Trial Outcomes & Findings for A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (NCT NCT01255761)
NCT ID: NCT01255761
Last Updated: 2018-07-31
Results Overview
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined. RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status.
COMPLETED
PHASE4
736 participants
Baseline (Week 0) to Week 12
2018-07-31
Participant Flow
Enrollment began in November 2010. Overall study completion occurred in December 2012. The Participant Flow consists of the Randomized Set (RS). The RS consists of all subjects randomized into the study. The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.
The Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. FAS-NRI: For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Participant milestones
| Measure |
RAPID3 to Assess Response to Cimzia
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Overall Study
STARTED
|
369
|
367
|
|
Overall Study
COMPLETED
|
187
|
192
|
|
Overall Study
NOT COMPLETED
|
182
|
175
|
Reasons for withdrawal
| Measure |
RAPID3 to Assess Response to Cimzia
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Overall Study
Adverse Event
|
29
|
43
|
|
Overall Study
Lack of Efficacy
|
86
|
74
|
|
Overall Study
Protocol Violation
|
9
|
5
|
|
Overall Study
Lost to Follow-up
|
10
|
8
|
|
Overall Study
Withdrawal by Subject
|
11
|
27
|
|
Overall Study
Other Reasons
|
37
|
18
|
Baseline Characteristics
A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects
Baseline characteristics by cohort
| Measure |
RAPID3 to Assess Response to Cimzia
n=369 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=367 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
Total
n=736 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
295 Participants
n=99 Participants
|
276 Participants
n=107 Participants
|
571 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 12.8 • n=107 Participants
|
54.9 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
280 Participants
n=99 Participants
|
293 Participants
n=107 Participants
|
573 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
369 participants
n=99 Participants
|
367 participants
n=107 Participants
|
736 participants
n=206 Participants
|
|
Weight
|
84.08 Kilogram
STANDARD_DEVIATION 21.35 • n=99 Participants
|
80.17 Kilogram
STANDARD_DEVIATION 19.23 • n=107 Participants
|
82.13 Kilogram
STANDARD_DEVIATION 20.40 • n=206 Participants
|
|
Height
|
164.94 Centimeters
STANDARD_DEVIATION 9.91 • n=99 Participants
|
164.00 Centimeters
STANDARD_DEVIATION 9.25 • n=107 Participants
|
164.47 Centimeters
STANDARD_DEVIATION 9.59 • n=206 Participants
|
|
Body Mass Index (BMI)
|
30.87 kg/ m^2
STANDARD_DEVIATION 7.23 • n=99 Participants
|
29.82 kg/ m^2
STANDARD_DEVIATION 6.90 • n=107 Participants
|
30.34 kg/ m^2
STANDARD_DEVIATION 7.08 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined. RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
Yes
|
64.7 percentage of participants
|
76.4 percentage of participants
|
|
Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
No
|
35.3 percentage of participants
|
23.6 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=238 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=279 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52
Yes
|
31.5 percentage of participants
|
32.3 percentage of participants
|
|
Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52
No
|
68.5 percentage of participants
|
67.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52
Yes
|
44.3 percentage of participants
|
51.8 percentage of participants
|
|
Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52
No
|
55.7 percentage of participants
|
48.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages. The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis.
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=238 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=279 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
Yes
|
21.8 percentage of participants
|
23.3 percentage of participants
|
|
Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
No
|
78.2 percentage of participants
|
76.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52
Yes
|
50.5 percentage of participants
|
58.6 percentage of participants
|
|
Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52
No
|
49.5 percentage of participants
|
41.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=355 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=355 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
|
-2.20 units on a scale
Standard Deviation 1.33
|
-2.11 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=355 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=355 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
|
-2.26 units on a scale
Standard Deviation 1.45
|
-2.14 units on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=361 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=357 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12
|
-23.79 units on a scale
Standard Deviation 14.35
|
-23.11 units on a scale
Standard Deviation 14.57
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=361 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=357 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52
|
-24.55 units on a scale
Standard Deviation 15.42
|
-23.16 units on a scale
Standard Deviation 15.20
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=361 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=357 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12
|
-6.78 units on a scale
Standard Deviation 5.94
|
-6.47 units on a scale
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=361 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=357 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52
|
-6.36 units on a scale
Standard Deviation 6.48
|
-6.65 units on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
Yes
|
25.0 percentage of subjects
|
28.2 percentage of subjects
|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
No
|
75.0 percentage of subjects
|
71.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
Yes
|
21.5 percentage of subjects
|
24.9 percentage of subjects
|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
No
|
78.5 percentage of subjects
|
75.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
Yes
|
12.8 percentage of subjects
|
15.6 percentage of subjects
|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
No
|
87.2 percentage of subjects
|
84.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
Yes
|
14.9 percentage of subjects
|
17.8 percentage of subjects
|
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
No
|
85.1 percentage of subjects
|
82.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
Yes
|
34.8 percentage of subjects
|
38.1 percentage of subjects
|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
No
|
65.2 percentage of subjects
|
61.9 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
Yes
|
30.2 percentage of subjects
|
33.4 percentage of subjects
|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
No
|
69.8 percentage of subjects
|
66.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
Yes
|
10.1 percentage of subjects
|
10.1 percentage of subjects
|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
No
|
89.9 percentage of subjects
|
89.9 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
Yes
|
12.2 percentage of subjects
|
15.6 percentage of subjects
|
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
No
|
87.8 percentage of subjects
|
84.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
Yes
|
33.7 percentage of subjects
|
33.4 percentage of subjects
|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
No
|
66.3 percentage of subjects
|
66.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
Yes
|
27.7 percentage of subjects
|
28.8 percentage of subjects
|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
No
|
72.3 percentage of subjects
|
71.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
Yes
|
14.9 percentage of subjects
|
18.9 percentage of subjects
|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
No
|
85.1 percentage of subjects
|
81.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline \& valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=368 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=365 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
Yes
|
18.8 percentage of subjects
|
20.8 percentage of subjects
|
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
No
|
81.3 percentage of subjects
|
79.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=149 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=134 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
0.7 Number of work days missed in last month
Standard Deviation 3.6
|
0.7 Number of work days missed in last month
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=149 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=134 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
1.1 Work days with reduced work productivity
Standard Deviation 3.5
|
1.2 Work days with reduced work productivity
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=149 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=134 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
1.7 units on a scale
Standard Deviation 2.3
|
1.6 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=321 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=314 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
3.2 Days with no household work
Standard Deviation 5.9
|
3.1 Days with no household work
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=320 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=312 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
3.1 Days with reduced household work
Standard Deviation 5.7
|
3.1 Days with reduced household work
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=321 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=314 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
0.7 Activity days missed
Standard Deviation 2.4
|
0.9 Activity days missed
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=321 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=314 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
0.4 Days with hired outside help
Standard Deviation 2.2
|
0.5 Days with hired outside help
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=321 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=314 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
|
2.7 units on a scale
Standard Deviation 2.7
|
2.4 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=88 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=84 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
0.2 Number of work days missed in last month
Standard Deviation 0.9
|
0.1 Number of work days missed in last month
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=88 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=84 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
0.6 Work days with reduced work productivity
Standard Deviation 2.1
|
0.3 Work days with reduced work productivity
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=88 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=83 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
0.7 units on a scale
Standard Deviation 1.4
|
0.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=172 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=180 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
1.1 Days with no household work
Standard Deviation 3.1
|
1.3 Days with no household work
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=172 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=180 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
1.3 Days with reduced household work
Standard Deviation 3.3
|
1.1 Days with reduced household work
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=172 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=180 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
0.4 Activity days missed
Standard Deviation 2.5
|
0.2 Activity days missed
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=172 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=180 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
0.1 Days with hired outside help
Standard Deviation 0.6
|
0.3 Days with hired outside help
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Outcome measures
| Measure |
RAPID3 to Assess Response to Cimzia
n=172 Participants
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=180 Participants
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
|
1.4 units on a scale
Standard Deviation 2.0
|
1.2 units on a scale
Standard Deviation 2.0
|
Adverse Events
RAPID3 to Assess Response to Cimzia
CDAI to Assess Response to Cimzia
Serious adverse events
| Measure |
RAPID3 to Assess Response to Cimzia
n=369 participants at risk
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=367 participants at risk
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.54%
2/367 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.82%
3/367 • Number of events 3 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.54%
2/367 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.54%
2/367 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.81%
3/369 • Number of events 3 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
General disorders
Spinal pain
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.54%
2/369 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.82%
3/367 • Number of events 4 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Lobar pneumonia
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.54%
2/367 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Critical illness myopathy
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Amnesia
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient global amnesia
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Multiple sclerosis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Optic neuritis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Myelopathy
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on oral contraceptive
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.27%
1/369 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.27%
1/369 • Number of events 2 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/369 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.27%
1/367 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Vascular disorders
Flushing
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.27%
1/369 • Number of events 1 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
0.00%
0/367 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
RAPID3 to Assess Response to Cimzia
n=369 participants at risk
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
|
CDAI to Assess Response to Cimzia
n=367 participants at risk
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.
Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
2.7%
10/369 • Number of events 10 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
6.0%
22/367 • Number of events 23 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
7.6%
28/369 • Number of events 34 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
5.4%
20/367 • Number of events 24 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
37/369 • Number of events 39 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
10.4%
38/367 • Number of events 41 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
39/369 • Number of events 53 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
10.4%
38/367 • Number of events 46 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
24/369 • Number of events 33 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
2.7%
10/367 • Number of events 11 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.1%
19/369 • Number of events 21 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
1.4%
5/367 • Number of events 5 • Adverse Events were collected from November 2010 through December 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set (SS) consisted of all subjects who received at least 1 dose of study medication.
|
Additional Information
(UCB) Study Director
UCB Clinical Trial Call Center
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER