Trial Outcomes & Findings for Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056 (NCT NCT01296711)
NCT ID: NCT01296711
Last Updated: 2022-04-14
Results Overview
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Results posted on
2022-04-14
Participant Flow
The present study was an open-label extension to study RA0056 (NCT01242488). Subjects completing the 12-week treatment period of study RA0056 had the opportunity to participate in this study. First subject enrolled: 07 March 2011. Early termination: 05 Aug 2013.
198 subjects completed the parent study RA0056 (NCT01242488); 190 subjects were enrolled in study RA0057. The study was a single treatment study and all subjects received CDP6038 (olokizumab) 120 mg sc q2w, however, some results are also presented according to the previously assigned treatment arms of the parent study RA0056.
Participant milestones
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
21
|
20
|
17
|
16
|
40
|
36
|
|
Overall Study
COMPLETED
|
4
|
12
|
8
|
7
|
7
|
5
|
9
|
15
|
|
Overall Study
NOT COMPLETED
|
16
|
8
|
13
|
13
|
10
|
11
|
31
|
21
|
Reasons for withdrawal
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
3
|
1
|
6
|
11
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
1
|
1
|
1
|
0
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
2
|
0
|
4
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
2
|
1
|
1
|
1
|
2
|
1
|
|
Overall Study
Study termination
|
8
|
1
|
5
|
4
|
4
|
4
|
8
|
10
|
|
Overall Study
Continued elevated liver enzymes
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Methotrexate discontinued
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Investigator discretion
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Required restricted steroid injections
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Ongoing missed appointments
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Failure to comply with visits
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Patient decision due to transport
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
Baseline characteristics by cohort
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
147 Participants
n=42 Participants
|
|
Age, Customized
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
161 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
167 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)Population: Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0057.
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
|
17 Participants
|
20 Participants
|
19 Participants
|
18 Participants
|
15 Participants
|
15 Participants
|
39 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)Population: Full Analysis Set (FAS) included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
DAS28(CRP) was calculated using the tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, the Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=13 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=17 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=19 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=15 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=15 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=15 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=32 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=29 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) to Week 12 of Study RA0057
|
-2.2809 units on a scale
Standard Deviation 1.45737 • Interval 1.45737 to
|
-2.2485 units on a scale
Standard Deviation 1.39384 • Interval 1.39384 to
|
-2.5123 units on a scale
Standard Deviation 1.39667 • Interval 1.39667 to
|
-2.2230 units on a scale
Standard Deviation 1.17572 • Interval 1.17572 to
|
-1.6957 units on a scale
Standard Deviation 0.67335 • Interval 0.67335 to
|
-2.1735 units on a scale
Standard Deviation 1.56606 • Interval 1.56606 to
|
-2.3727 units on a scale
Standard Deviation 1.41421 • Interval 1.41421 to
|
-2.4710 units on a scale
Standard Deviation 1.43947 • Interval 1.43947 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=13 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=14 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=19 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=10 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=13 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=31 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=29 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
|
-2.6441 units on a scale
Standard Deviation 1.46566 • Interval 1.46566 to
|
1.46566 units on a scale
Standard Deviation 1.17637 • Interval 1.17637 to
|
-2.5811 units on a scale
Standard Deviation 1.40191 • Interval 1.40191 to
|
-2.5999 units on a scale
Standard Deviation 1.16812 • Interval 1.16812 to
|
-1.7189 units on a scale
Standard Deviation 0.87218 • Interval 0.87218 to
|
-2.4221 units on a scale
Standard Deviation 1.37341 • Interval 1.37341 to
|
-2.1484 units on a scale
Standard Deviation 1.34676 • Interval 1.34676 to
|
-2.7624 units on a scale
Standard Deviation 1.47841 • Interval 1.47841 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=12 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=13 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=10 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=12 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=10 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=20 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=22 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
|
-2.3257 units on a scale
Standard Deviation 1.07427 • Interval 1.07427 to
|
-2.2498 units on a scale
Standard Deviation 1.66580 • Interval 1.6658 to
|
-2.5277 units on a scale
Standard Deviation 1.56763 • Interval 1.56763 to
|
-2.7050 units on a scale
Standard Deviation 0.96160 • Interval 0.9616 to
|
-2.3824 units on a scale
Standard Deviation 0.79065 • Interval 0.79065 to
|
-2.1501 units on a scale
Standard Deviation 0.64141 • Interval 0.64141 to
|
-2.2403 units on a scale
Standard Deviation 1.47765 • Interval 1.47765 to
|
-2.7611 units on a scale
Standard Deviation 1.31329 • Interval 1.31329 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=1 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=3 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=2 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=3 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=2 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=2 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=5 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
|
-3.2427 units on a scale
Standard Deviation 1.74642
|
-3.5767 units on a scale
|
-2.5985 units on a scale
Standard Deviation 2.16200
|
-3.0999 units on a scale
Standard Deviation 0.02877
|
-1.7516 units on a scale
Standard Deviation 2.03992
|
-2.6451 units on a scale
Standard Deviation 0.96108
|
-3.3173 units on a scale
Standard Deviation 3.23508
|
-3.7982 units on a scale
Standard Deviation 1.23889
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
|
40.0 Percentage of responders
|
50.0 Percentage of responders
|
76.2 Percentage of responders
|
35.0 Percentage of responders
|
58.8 Percentage of responders
|
50.0 Percentage of responders
|
47.5 Percentage of responders
|
52.8 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
|
40.0 Percentage of responders
|
50.0 Percentage of responders
|
66.7 Percentage of responders
|
30.0 Percentage of responders
|
47.1 Percentage of responders
|
62.5 Percentage of responders
|
42.5 Percentage of responders
|
63.9 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
|
40.0 Percentage of responders
|
30.0 Percentage of responders
|
42.9 Percentage of responders
|
35.0 Percentage of responders
|
47.1 Percentage of responders
|
43.8 Percentage of responders
|
25.0 Percentage of responders
|
50.0 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
|
15.0 Percentage of responders
|
5.0 Percentage of responders
|
9.5 Percentage of responders
|
5.0 Percentage of responders
|
11.8 Percentage of responders
|
12.5 Percentage of responders
|
2.5 Percentage of responders
|
13.9 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
|
25.0 Percentage of responders
|
15.0 Percentage of responders
|
33.3 Percentage of responders
|
15.0 Percentage of responders
|
17.6 Percentage of responders
|
18.8 Percentage of responders
|
27.5 Percentage of responders
|
38.9 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
|
20.0 Percentage of responders
|
20.0 Percentage of responders
|
33.3 Percentage of responders
|
15.0 Percentage of responders
|
11.8 Percentage of responders
|
43.8 Percentage of responders
|
25.0 Percentage of responders
|
41.7 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
|
10.0 Percentage of responders
|
15.0 Percentage of responders
|
28.6 Percentage of responders
|
20.0 Percentage of responders
|
35.3 Percentage of responders
|
31.3 Percentage of responders
|
15.0 Percentage of responders
|
33.3 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
|
10.0 Percentage of responders
|
5.0 Percentage of responders
|
4.8 Percentage of responders
|
0.0 Percentage of responders
|
11.8 Percentage of responders
|
6.3 Percentage of responders
|
2.5 Percentage of responders
|
8.3 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
|
10.0 Percentage of responders
|
5.0 Percentage of responders
|
19.0 Percentage of responders
|
5.0 Percentage of responders
|
0.0 Percentage of responders
|
18.8 Percentage of responders
|
15.0 Percentage of responders
|
13.9 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
|
10.0 Percentage of responders
|
15.0 Percentage of responders
|
19.0 Percentage of responders
|
5.0 Percentage of responders
|
0.0 Percentage of responders
|
12.5 Percentage of responders
|
10.0 Percentage of responders
|
25.0 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
|
5.0 Percentage of responders
|
5.0 Percentage of responders
|
23.8 Percentage of responders
|
10.0 Percentage of responders
|
11.8 Percentage of responders
|
6.3 Percentage of responders
|
10.0 Percentage of responders
|
13.9 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
|
5.0 Percentage of responders
|
0.0 Percentage of responders
|
4.8 Percentage of responders
|
0.0 Percentage of responders
|
5.9 Percentage of responders
|
0.0 Percentage of responders
|
2.5 Percentage of responders
|
5.6 Percentage of responders
|
SECONDARY outcome
Timeframe: Week 12 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057
|
25.0 Percentage of subjects
|
30.0 Percentage of subjects
|
38.1 Percentage of subjects
|
25.0 Percentage of subjects
|
0 Percentage of subjects
|
18.8 Percentage of subjects
|
25.0 Percentage of subjects
|
25.0 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 24 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057
|
25.0 Percentage of subjects
|
35.0 Percentage of subjects
|
33.3 Percentage of subjects
|
25.0 Percentage of subjects
|
17.6 Percentage of subjects
|
12.5 Percentage of subjects
|
20.0 Percentage of subjects
|
33.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057
|
20.0 Percentage of subjects
|
30.0 Percentage of subjects
|
23.8 Percentage of subjects
|
20.0 Percentage of subjects
|
29.4 Percentage of subjects
|
12.5 Percentage of subjects
|
15.0 Percentage of subjects
|
22.2 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057
|
10.0 Percentage of subjects
|
5.0 Percentage of subjects
|
9.5 Percentage of subjects
|
5.0 Percentage of subjects
|
11.8 Percentage of subjects
|
0 Percentage of subjects
|
2.5 Percentage of subjects
|
8.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 12 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to (\<=) 3.2 implies low disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057
|
35.6 Percentage of subjects
|
40.0 Percentage of subjects
|
52.4 Percentage of subjects
|
30.0 Percentage of subjects
|
17.6 Percentage of subjects
|
25.0 Percentage of subjects
|
35.0 Percentage of subjects
|
44.4 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 24 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score \<=3.2 implies low disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057
|
35.0 Percentage of subjects
|
40.0 Percentage of subjects
|
38.1 Percentage of subjects
|
30.0 Percentage of subjects
|
23.5 Percentage of subjects
|
37.5 Percentage of subjects
|
35.0 Percentage of subjects
|
50.0 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score \<=3.2 implies low disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057
|
25.0 Percentage of subjects
|
45.0 Percentage of subjects
|
23.8 Percentage of subjects
|
25.0 Percentage of subjects
|
29.4 Percentage of subjects
|
18.8 Percentage of subjects
|
22.5 Percentage of subjects
|
47.2 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score \<=3.2 implies low disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057
|
15.0 Percentage of subjects
|
5.0 Percentage of subjects
|
9.5 Percentage of subjects
|
5.0 Percentage of subjects
|
11.8 Percentage of subjects
|
0 Percentage of subjects
|
2.5 Percentage of subjects
|
11.1 Percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=13 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=14 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=10 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=12 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=10 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=20 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=23 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057
|
-80.1000 units on a scale
Standard Deviation 53.28425 • Interval 53.28425 to
|
-65.3373 units on a scale
Standard Deviation 63.72098 • Interval 63.72098 to
|
-94.3335 units on a scale
Standard Deviation 61.48562 • Interval 61.48562 to
|
-80.8077 units on a scale
Standard Deviation 57.91606 • Interval 57.91606 to
|
-79.9231 units on a scale
Standard Deviation 30.09849 • Interval 30.09849 to
|
-84.8378 units on a scale
Standard Deviation 33.77586 • Interval 33.77586 to
|
-74.3315 units on a scale
Standard Deviation 53.99274 • Interval 53.99274 to
|
-83.4950 units on a scale
Standard Deviation 42.48396 • Interval 42.48396 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=1 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=3 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=2 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=3 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=2 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=2 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=5 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057
|
-108.0000 units on a scale
Standard Deviation 66.77574
|
-118.0000 units on a scale
|
-89.0000 units on a scale
Standard Deviation 55.97321
|
-74.3846 units on a scale
Standard Deviation 4.78657
|
-74.0000 units on a scale
Standard Deviation 55.74944
|
-90.5000 units on a scale
Standard Deviation 13.43503
|
-104.5000 units on a scale
Standard Deviation 126.57211
|
-107.4000 units on a scale
Standard Deviation 51.52960
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre \[mg/dL\]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=13 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=13 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=10 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=12 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=10 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=20 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=23 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057
|
-92.1000 units on a scale
Standard Deviation 62.22799 • Interval 62.22799 to
|
-75.8757 units on a scale
Standard Deviation 74.37825 • Interval 74.37825 to
|
-104.6668 units on a scale
Standard Deviation 80.47988 • Interval 80.47988 to
|
-92.4077 units on a scale
Standard Deviation 55.42723 • Interval 55.42723 to
|
-87.7564 units on a scale
Standard Deviation 28.41084 • Interval 28.41084 to
|
-112.5378 units on a scale
Standard Deviation 52.99896 • Interval 52.99896 to
|
-87.5815 units on a scale
Standard Deviation 59.26016 • Interval 59.26016 to
|
-107.4080 units on a scale
Standard Deviation 60.17362 • Interval 60.17362 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre \[mg/dL\]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=1 Participants
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=3 Participants
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=2 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=3 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=2 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=2 Participants
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=5 Participants
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057
|
-111.0000 units on a scale
Standard Deviation 68.78953
|
-125.0000 units on a scale
|
-90.3333 units on a scale
Standard Deviation 56.04760
|
-91.8846 units on a scale
Standard Deviation 29.53531
|
-75.3333 units on a scale
Standard Deviation 56.09219
|
-147.5000 units on a scale
Standard Deviation 77.07464
|
-128.0000 units on a scale
Standard Deviation 147.07821
|
-143.4000 units on a scale
Standard Deviation 80.28574
|
Adverse Events
RA0056 CDP6038 (Olokizumab) 120 mg q2w
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
RA0056 CDP6038 (Olokizumab) 240 mg q2w
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
RA0056 CDP6038 (Olokizumab) 240 mg q4w
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
RA0056 CDP6038 (Olokizumab) 60 mg q2w
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
RA0056 CDP6038 (Olokizumab) 60 mg q4w
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
RA0056 Placebo
Serious events: 14 serious events
Other events: 36 other events
Deaths: 1 deaths
RA0056 Tocilizumab 8 mg/kg q4w
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 participants at risk
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 participants at risk
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 participants at risk
CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056).
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 participants at risk
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 participants at risk
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 participants at risk
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 participants at risk
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 participants at risk
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Staphylococcal infection
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Localised infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Gangrene
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Furuncle
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Endocrine disorders
Goitre
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Chest pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Unevaluable event
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Multi-organ failure
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
Other adverse events
| Measure |
RA0056 CDP6038 (Olokizumab) 120 mg q2w
n=20 participants at risk
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 120 mg q4w
n=20 participants at risk
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 240 mg q2w
n=21 participants at risk
CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056).
|
RA0056 CDP6038 (Olokizumab) 240 mg q4w
n=20 participants at risk
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q2w
n=17 participants at risk
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 CDP6038 (Olokizumab) 60 mg q4w
n=16 participants at risk
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Placebo
n=40 participants at risk
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
RA0056 Tocilizumab 8 mg/kg q4w
n=36 participants at risk
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
14.3%
3/21 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 6 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 6 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Eye disorders
Eye pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
14.3%
3/21 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
17.5%
7/40 • Number of events 8 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.1%
4/36 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
14.3%
3/21 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
5/40 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
14.3%
3/21 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
18.8%
3/16 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
5/40 • Number of events 7 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Herpes zoster
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
30.0%
6/20 • Number of events 10 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
4/40 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
16.7%
6/36 • Number of events 7 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
42.9%
9/21 • Number of events 12 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
23.5%
4/17 • Number of events 6 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
18.8%
3/16 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
17.5%
7/40 • Number of events 10 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
13.9%
5/36 • Number of events 9 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
28.6%
6/21 • Number of events 24 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
18.8%
3/16 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
5/40 • Number of events 12 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
13.9%
5/36 • Number of events 11 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Skin infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Infections and infestations
Viral infection
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 8 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Lipids increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Mammogram abnormal
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Investigations
Red cell distribution width increased
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 6 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
17.6%
3/17 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
5/40 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
16.7%
6/36 • Number of events 10 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
4/40 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
3/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
18.8%
3/16 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.1%
4/36 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
25.0%
5/20 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
17.5%
7/40 • Number of events 7 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.1%
4/36 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
30.0%
6/20 • Number of events 7 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.1%
4/36 • Number of events 8 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
4/40 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.0%
1/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
20.0%
4/20 • Number of events 6 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
14.3%
3/21 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
25.0%
4/16 • Number of events 6 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
6/40 • Number of events 7 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
13.9%
5/36 • Number of events 8 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
18.8%
3/16 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mass
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
5/20 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
4.8%
1/21 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
15.0%
3/20 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
14.3%
3/21 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
13.9%
5/36 • Number of events 5 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
12.5%
2/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
4/40 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site reaction
|
10.0%
2/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
10.0%
2/20 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
11.8%
2/17 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
15.0%
6/40 • Number of events 8 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
22.2%
8/36 • Number of events 14 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
9.5%
2/21 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 3 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 9 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
2/40 • Number of events 4 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site bruising
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.0%
1/20 • Number of events 11 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
7.5%
3/40 • Number of events 18 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
8.3%
3/36 • Number of events 21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site induration
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site rash
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.9%
1/17 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/36 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Injection site swelling
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
6.2%
1/16 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.8%
1/36 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
2.5%
1/40 • Number of events 1 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
|
General disorders
Pain
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/21 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/20 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/17 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/16 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
0.00%
0/40 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
5.6%
2/36 • Number of events 2 • From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
|
Additional Information
Clin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Phone: 001-844-599-2273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. The Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER