Trial Outcomes & Findings for Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis (NCT NCT01443364)
NCT ID: NCT01443364
Last Updated: 2017-08-15
Results Overview
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
COMPLETED
PHASE4
132 participants
From Baseline to Week 12 and Week 52
2017-08-15
Participant Flow
This study started to enroll patients in December 2011 and concluded in May 2015.
Participant Flow refers to all subjects randomized who have received at least one dose of study medication.
Participant milestones
| Measure |
Certolizumab Pegol
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Certolizumab Pegol
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
14
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Other Reason
|
4
|
|
Overall Study
SAE, non-fatal
|
6
|
|
Overall Study
AE, non-serious non-fatal
|
8
|
|
Overall Study
SAE, non-fatal+AE, non-serious non-fatal
|
1
|
Baseline Characteristics
Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Certolizumab Pegol
n=132 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=99 Participants
|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Weight
|
69.33 kilogram
STANDARD_DEVIATION 14.10 • n=99 Participants
|
|
Height
|
164.16 centimeter
STANDARD_DEVIATION 8.48 • n=99 Participants
|
|
BMI
|
25.66 kg/m^2
STANDARD_DEVIATION 4.52 • n=99 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12 and Week 52Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
Outcome measures
| Measure |
Certolizumab Pegol
n=131 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
|
69.1 percentage of subjects
Interval 58.78 to 78.27
|
PRIMARY outcome
Timeframe: From Baseline to Week 8 and Week 52Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
Outcome measures
| Measure |
Certolizumab Pegol
n=131 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52
|
69.8 percentage of subjects
Interval 59.57 to 78.75
|
PRIMARY outcome
Timeframe: From Baseline to Week 6 and Week 52Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
Outcome measures
| Measure |
Certolizumab Pegol
n=131 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52
|
65.2 percentage of subjects
Interval 54.33 to 74.96
|
PRIMARY outcome
Timeframe: From Baseline to Week 4 and Week 52Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
Outcome measures
| Measure |
Certolizumab Pegol
n=131 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52
|
66.7 percentage of subjects
Interval 56.13 to 76.11
|
PRIMARY outcome
Timeframe: From Baseline to Week 2 and Week 52Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
Outcome measures
| Measure |
Certolizumab Pegol
n=131 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52
|
64.9 percentage of subjects
Interval 52.89 to 75.61
|
PRIMARY outcome
Timeframe: From Baseline to Week 1 and Week 52Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
Outcome measures
| Measure |
Certolizumab Pegol
n=131 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52
|
55.8 percentage of subjects
Interval 39.88 to 70.92
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 52
|
-1.0 units on a scale
Interval -9.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 36
|
-1.0 units on a scale
Interval -9.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 24
|
-1.0 units on a scale
Interval -9.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 12
|
-1.0 units on a scale
Interval -12.0 to 5.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 8
|
-1.0 units on a scale
Interval -12.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 6
|
-1.0 units on a scale
Interval -10.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 4
|
-1.0 units on a scale
Interval -8.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=57 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 2
|
-1.0 units on a scale
Interval -5.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=53 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Synovial Fluid and Proliferation at Week 1
|
0.0 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 52
|
-1.0 units on a scale
Interval -12.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 36
|
-1.0 units on a scale
Interval -11.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 24
|
-1.0 units on a scale
Interval -11.0 to 6.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 12
|
-1.0 units on a scale
Interval -12.0 to 9.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 8
|
-1.0 units on a scale
Interval -12.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 6
|
-1.0 units on a scale
Interval -12.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 4
|
-0.5 units on a scale
Interval -10.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=57 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 2
|
0.0 units on a scale
Interval -10.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=53 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Doppler Signal and Blood Flow at Week 1
|
0.0 units on a scale
Interval -10.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=55 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 52
|
0.0 units on a scale
Interval -11.0 to 8.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=55 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 36
|
0.0 units on a scale
Interval -12.0 to 16.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 24
|
0.0 units on a scale
Interval -13.0 to 11.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 12
|
0.0 units on a scale
Interval -11.0 to 11.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 8
|
0.0 units on a scale
Interval -11.0 to 9.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 6
|
0.0 units on a scale
Interval -11.0 to 7.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 4
|
0.0 units on a scale
Interval -11.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=53 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 2
|
0.0 units on a scale
Interval -11.0 to 9.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=50 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Cartilage Damage at Week 1
|
0.0 units on a scale
Interval -8.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 52
|
0.0 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 36
|
0.0 units on a scale
Interval -5.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 24
|
0.0 units on a scale
Interval -5.0 to 10.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 12
|
0.0 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 8
|
0.0 units on a scale
Interval -5.0 to 5.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 6
|
0.0 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 4
|
0.0 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=57 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 2
|
0.0 units on a scale
Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=53 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Bone Erosion at Week 1
|
0.0 units on a scale
Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
|
-3.0 units on a scale
Interval -20.0 to 5.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
|
-3.0 units on a scale
Interval -20.0 to 6.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
|
-3.0 units on a scale
Interval -20.0 to 10.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
|
-3.0 units on a scale
Interval -23.0 to 14.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
|
-3.0 units on a scale
Interval -23.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
|
-2.5 units on a scale
Interval -20.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=58 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
|
-2.5 units on a scale
Interval -17.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=57 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
|
-2.0 units on a scale
Interval -13.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=53 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
|
-1.0 units on a scale
Interval -13.0 to 3.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=55 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
|
-2.0 units on a scale
Interval -15.0 to 9.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=55 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
|
-2.0 units on a scale
Interval -15.0 to 17.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
|
-1.5 units on a scale
Interval -15.0 to 10.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
|
-2.0 units on a scale
Interval -15.0 to 11.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
|
-2.0 units on a scale
Interval -13.0 to 11.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
|
-2.0 units on a scale
Interval -15.0 to 5.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=54 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
|
-1.0 units on a scale
Interval -15.0 to 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=53 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
|
-1.0 units on a scale
Interval -15.0 to 9.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=50 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
|
-1.0 units on a scale
Interval -10.0 to 4.0
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 52
|
5.0 units on a scale
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 36
|
5.0 units on a scale
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 24
|
5.0 units on a scale
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 12
|
5.0 units on a scale
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 8
|
5.0 units on a scale
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 6
|
6.0 units on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 4
|
6.0 units on a scale
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 2
|
7.0 units on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 1
|
7.0 units on a scale
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline)Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Synovial Fluid and Proliferation at Week 0
|
8.0 units on a scale
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 52
|
0.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 36
|
0.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 24
|
0.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 12
|
0.0 units on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 8
|
0.0 units on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 6
|
0.5 units on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 4
|
2.0 units on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 2
|
1.0 units on a scale
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 1
|
1.0 units on a scale
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline)Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Doppler Signal and Blood Flow at Week 0
|
2.0 units on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 52
|
4.0 units on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 36
|
5.0 units on a scale
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 24
|
4.5 units on a scale
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 12
|
5.0 units on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 8
|
4.5 units on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 6
|
4.0 units on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 4
|
4.0 units on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=61 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 2
|
4.0 units on a scale
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=57 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 1
|
5.0 units on a scale
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline)Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=56 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Cartilage Damage at Week 0
|
6.0 units on a scale
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 52
|
2.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 36
|
2.0 units on a scale
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 24
|
2.0 units on a scale
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 12
|
2.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 8
|
2.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 6
|
2.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 4
|
2.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 2
|
2.0 units on a scale
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 1
|
2.0 units on a scale
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline)Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=60 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Bone Erosion at Week 0
|
2.0 units on a scale
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
|
5.0 units on a scale
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
|
6.0 units on a scale
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
|
6.5 units on a scale
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
|
7.0 units on a scale
Interval 0.0 to 22.0
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
|
6.0 units on a scale
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
|
7.0 units on a scale
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
|
8.0 units on a scale
Interval 0.0 to 18.0
|
SECONDARY outcome
Timeframe: Week 2The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
|
8.0 units on a scale
Interval 0.0 to 23.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
|
8.0 units on a scale
Interval 1.0 to 23.0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline)Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Outcome measures
| Measure |
Certolizumab Pegol
n=59 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0
|
10.0 units on a scale
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
|
7.0 units on a scale
Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: Week 36Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=65 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
|
8.0 units on a scale
Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
|
10.0 units on a scale
Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
|
9.0 units on a scale
Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=64 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
|
9.0 units on a scale
Interval 0.0 to 34.0
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
|
8.0 units on a scale
Interval 0.0 to 33.0
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=63 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
|
8.0 units on a scale
Interval 0.0 to 34.0
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=61 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
|
10.0 units on a scale
Interval 0.0 to 43.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=57 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
|
10.0 units on a scale
Interval 0.0 to 47.0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline)Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Outcome measures
| Measure |
Certolizumab Pegol
n=55 Participants
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0
|
12.0 units on a scale
Interval 0.0 to 47.0
|
Adverse Events
Certolizumab Pegol
Serious adverse events
| Measure |
Certolizumab Pegol
n=132 participants at risk
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Eye disorders
Periorbital oedema
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Bronchopneumonia
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Endophthalmitis
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Paratyphoid fever
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lobular breast carcinoma in situ
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Anosmia
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Renal and urinary disorders
Bladder mass
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Vascular disorders
Flushing
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.76%
1/132 • Number of events 1 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
Other adverse events
| Measure |
Certolizumab Pegol
n=132 participants at risk
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
|
|---|---|
|
General disorders
Pyrexia
|
5.3%
7/132 • Number of events 7 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
11.4%
15/132 • Number of events 16 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
5.3%
7/132 • Number of events 7 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
9/132 • Number of events 18 • Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60