Trial Outcomes & Findings for Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (NCT NCT02379091)
NCT ID: NCT02379091
Last Updated: 2018-09-14
Results Overview
The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], general health: patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-09-14
Participant Flow
Participants took part in the study at 28 investigative sites in Bulgaria, Czech Republic, Japan, Poland, Russian Federation, Spain and the United Kingdom from 17 December 2014 to 05 December 2016.
Participants with a diagnosis of moderate to severe Rheumatoid Arthritis were enrolled equally in one of 4 treatment groups: placebo or 20, 80, 150 mg/mL namilumab.
Participant milestones
| Measure |
Placebo
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
25
|
28
|
|
Overall Study
Full Analysis Set
|
26
|
28
|
24
|
28
|
|
Overall Study
COMPLETED
|
15
|
18
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
7
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
2
|
0
|
1
|
|
Overall Study
Principal Investigator Discretion
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Voluntary Withdrawal
|
2
|
5
|
2
|
4
|
|
Overall Study
Study Termination
|
7
|
2
|
5
|
8
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=25 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 13.45 • n=99 Participants
|
46.1 years
STANDARD_DEVIATION 10.07 • n=107 Participants
|
49.0 years
STANDARD_DEVIATION 9.60 • n=206 Participants
|
51.3 years
STANDARD_DEVIATION 14.13 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 12.02 • n=31 Participants
|
|
Age, Customized
< 45 years
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Age, Customized
45 to 64 years
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
|
Age, Customized
65 to 74 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Age, Customized
>= 75 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
84 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
88 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
89 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
Bulgaria
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Region of Enrollment
Czech Republic
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Region of Enrollment
Russia
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Height
|
164.3 cm
STANDARD_DEVIATION 10.51 • n=99 Participants
|
167.7 cm
STANDARD_DEVIATION 6.65 • n=107 Participants
|
167.4 cm
STANDARD_DEVIATION 8.36 • n=206 Participants
|
166.5 cm
STANDARD_DEVIATION 9.24 • n=7 Participants
|
166.5 cm
STANDARD_DEVIATION 8.78 • n=31 Participants
|
|
Weight
|
63.89 kg
STANDARD_DEVIATION 14.511 • n=99 Participants
|
70.28 kg
STANDARD_DEVIATION 15.911 • n=107 Participants
|
76.56 kg
STANDARD_DEVIATION 18.660 • n=206 Participants
|
72.23 kg
STANDARD_DEVIATION 19.168 • n=7 Participants
|
70.64 kg
STANDARD_DEVIATION 17.499 • n=31 Participants
|
|
Body Mass Index (BMI)
|
23.75 kg/m^2
STANDARD_DEVIATION 5.542 • n=99 Participants
|
24.91 kg/m^2
STANDARD_DEVIATION 5.210 • n=107 Participants
|
27.16 kg/m^2
STANDARD_DEVIATION 5.605 • n=206 Participants
|
25.92 kg/m^2
STANDARD_DEVIATION 6.313 • n=7 Participants
|
25.41 kg/m^2
STANDARD_DEVIATION 5.741 • n=31 Participants
|
|
BMI Categories
< 30 kg/m^2
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
85 Participants
n=31 Participants
|
|
BMI Categories
>= 30 kg/m^2
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Smoking classification
Participant has never smoked
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
|
Smoking classification
Participant is a current smoker
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Smoking classification
Participant is an ex-smoker
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Participants from the Full Analysis Set (FAS), all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in double-blind period up to Week 12, with data available at Baseline and Week 12 for analysis.
The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], general health: patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.
Outcome measures
| Measure |
Placebo
n=24 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=25 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=22 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=26 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12
|
-0.77 score on a scale
Standard Error 0.294
|
-1.38 score on a scale
Standard Error 0.288
|
-1.36 score on a scale
Standard Error 0.302
|
-1.69 score on a scale
Standard Error 0.286
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 24Population: FAS includes all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12. Number analyzed is the number of participants with data available for analysis at the given time point.
ACR20/50/70 response is defined as a ≥20/50/70% reduction from Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), and the following: * Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain * Patient's Global Assessment of Disease Activity * Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity * Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do * Acute-phase reactant: C-reactive Protein (CRP).
Outcome measures
| Measure |
Placebo
n=26 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=24 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
ACR 50, Week 12
|
16.7 percentage of participants
|
20.0 percentage of participants
|
30.4 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
ACR 70, Week 12
|
8.3 percentage of participants
|
4.0 percentage of participants
|
21.7 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
ACR 20, Week 12
|
37.5 percentage of participants
|
72.0 percentage of participants
|
52.2 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
ACR 20, Week 24
|
33.3 percentage of participants
|
65.2 percentage of participants
|
47.8 percentage of participants
|
56.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
ACR 50, Week 24
|
23.8 percentage of participants
|
34.8 percentage of participants
|
47.8 percentage of participants
|
36.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
ACR 70, Week 24
|
19.0 percentage of participants
|
13.0 percentage of participants
|
30.4 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis.
ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.
Outcome measures
| Measure |
Placebo
n=24 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=25 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=23 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=26 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
ACR Numeric (N) Index (ACRn) at Week 12
|
-17.25 percentage change
Standard Error 16.469
|
3.97 percentage change
Standard Error 16.372
|
19.68 percentage change
Standard Error 16.875
|
17.14 percentage change
Standard Error 16.098
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis. Post-escape data is included.
ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.
Outcome measures
| Measure |
Placebo
n=26 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=24 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
ACR Numeric (N) Index (ACRn) at Week 24
|
34.04 percentage change
Standard Deviation 40.248
|
35.35 percentage change
Standard Deviation 50.191
|
44.66 percentage change
Standard Deviation 38.203
|
36.57 percentage change
Standard Deviation 38.709
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 6 and 10Population: FAS includes all participants in the safety analysis set who had at least 1 valid postbaseline assessment of DAS28-CRP in the double-blind period up to Week 12. Number analyzed is the number of participants with data available for analysis at the given time point.
The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], general health: patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.
Outcome measures
| Measure |
Placebo
n=26 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=24 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10
Change at Week 10
|
-0.75 score on a scale
Standard Error 0.280
|
-1.19 score on a scale
Standard Error 0.273
|
-1.39 score on a scale
Standard Error 0.289
|
-1.51 score on a scale
Standard Error 0.269
|
|
Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10
Change at Week 2
|
-0.33 score on a scale
Standard Error 0.236
|
-0.58 score on a scale
Standard Error 0.222
|
-0.84 score on a scale
Standard Error 0.245
|
-0.95 score on a scale
Standard Error 0.224
|
|
Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10
Change at Week 6
|
-0.70 score on a scale
Standard Error 0.268
|
-1.13 score on a scale
Standard Error 0.256
|
-1.37 score on a scale
Standard Error 0.275
|
-1.42 score on a scale
Standard Error 0.257
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis at Baseline and Week 24.
The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], general health: patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=12 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=18 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=16 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=17 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP at Week 24
|
-1.75 score on a scale
Standard Deviation 1.401
|
-2.37 score on a scale
Standard Deviation 1.083
|
-2.20 score on a scale
Standard Deviation 1.219
|
-2.26 score on a scale
Standard Deviation 0.962
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 12 and 24Population: Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis. Number analyzed is the number of participants with data available for analysis at the given time point.
Reduction of Pain, defined as a ≥40% change from Baseline as measured using a 100 mm Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain at weeks 2, 12 and 24.
Outcome measures
| Measure |
Placebo
n=26 Participants
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 Participants
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=24 Participants
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 Participants
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24
Week 2
|
7.7 percentage of participants
|
14.3 percentage of participants
|
8.7 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24
Week 24
|
22.7 percentage of participants
|
43.5 percentage of participants
|
47.8 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24
Week 12
|
20.8 percentage of participants
|
44.0 percentage of participants
|
39.1 percentage of participants
|
30.8 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Namilumab 20 mg/mL
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Namilumab 80 mg/mL
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Namilumab 150 mg/mL
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo to Namilumab 150 mg/mL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Namilumab to Namilumab 150 mg/mL
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=27 participants at risk
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 participants at risk
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=25 participants at risk
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 participants at risk
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Placebo to Namilumab 150 mg/mL
n=12 participants at risk
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by Namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab to Namilumab 150 mg/mL
n=24 participants at risk
Namilumab 20 or 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 20 mg/mL
n=28 participants at risk
Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 80 mg/mL
n=25 participants at risk
Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab 150 mg/mL
n=28 participants at risk
Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Placebo to Namilumab 150 mg/mL
n=12 participants at risk
Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by Namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
Namilumab to Namilumab 150 mg/mL
n=24 participants at risk
Namilumab 20 or 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 12; followed by namilumab 150 mg/mL, SC injection, every 4 weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
1/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
18.5%
5/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
7/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.9%
5/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
7.4%
2/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.7%
1/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.0%
3/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
2/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
2/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/27 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • First dose of study drug to 30 days after last dose of study drug (Up to 46.4 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER