Trial Outcomes & Findings for The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis (NCT NCT01533714)
NCT ID: NCT01533714
Last Updated: 2022-05-20
Results Overview
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Results posted on
2022-05-20
Participant Flow
The present study was an open-label extension to study RA0083 (NCT01463059). Subjects completing the 12-week treatment period of study RA0083 had the opportunity to participate in this study. First subject enrolled: 26 January 2012. Last subject completed: 27 November 2013.
105 subjects completed the parent Study RA0083 (NCT01463059); 103 subjects were enrolled in Study RA0089.
Participant milestones
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
15
|
11
|
15
|
28
|
24
|
|
Overall Study
COMPLETED
|
10
|
12
|
7
|
11
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
4
|
4
|
7
|
3
|
Reasons for withdrawal
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
2
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Exclusion criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Positive for purified protein derivative
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal criteria
|
0
|
0
|
1
|
0
|
3
|
1
|
|
Overall Study
Ineligibility reason
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=15 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)Population: Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0089.
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=15 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
|
8 Participants
|
13 Participants
|
10 Participants
|
12 Participants
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)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 RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per 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 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. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (\>) 5.1 correspond with active disease, scores less than (\<) 3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=14 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=10 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=13 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=23 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=23 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
|
-2.9618 units on a scale
Standard Deviation 1.05692
|
-2.5358 units on a scale
Standard Deviation 1.11550
|
-2.9758 units on a scale
Standard Deviation 1.23346
|
-2.7948 units on a scale
Standard Deviation 1.28792
|
-2.6837 units on a scale
Standard Deviation 0.80614
|
-2.5902 units on a scale
Standard Deviation 1.06296
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)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 RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=8 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=9 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=10 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=11 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=22 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=22 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
|
-2.6916 units on a scale
Standard Deviation 0.75807
|
-3.3277 units on a scale
Standard Deviation 1.05841
|
-3.3523 units on a scale
Standard Deviation 0.74516
|
-2.8884 units on a scale
Standard Deviation 1.43276
|
-3.0176 units on a scale
Standard Deviation 0.82217
|
-2.8235 units on a scale
Standard Deviation 0.99271
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)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 RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=6 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=4 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=7 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=9 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
|
-2.6243 units on a scale
Standard Deviation 1.52735
|
-3.2720 units on a scale
Standard Deviation 0.97343
|
-3.2397 units on a scale
Standard Deviation 0.85356
|
-2.9625 units on a scale
Standard Deviation 1.16236
|
-2.4750 units on a scale
Standard Deviation 1.31771
|
-3.2211 units on a scale
Standard Deviation 0.45471
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)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 RA0089.
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
|
100.0 Percentage of responders
|
60.0 Percentage of responders
|
81.8 Percentage of responders
|
71.4 Percentage of responders
|
64.3 Percentage of responders
|
70.8 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)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 RA0089.
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
|
60.0 Percentage of responders
|
46.7 Percentage of responders
|
81.8 Percentage of responders
|
57.1 Percentage of responders
|
71.4 Percentage of responders
|
66.7 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)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 RA0089.
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
|
20.0 Percentage of responders
|
13.3 Percentage of responders
|
54.5 Percentage of responders
|
21.4 Percentage of responders
|
21.4 Percentage of responders
|
33.3 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)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 RA0089.
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
|
70.0 Percentage of responders
|
40.0 Percentage of responders
|
54.5 Percentage of responders
|
42.9 Percentage of responders
|
42.9 Percentage of responders
|
50.0 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)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 RA0089.
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
|
40.0 Percentage of responders
|
40.0 Percentage of responders
|
63.6 Percentage of responders
|
57.1 Percentage of responders
|
42.9 Percentage of responders
|
45.8 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)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 RA0089.
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
|
20.0 Percentage of responders
|
13.3 Percentage of responders
|
45.5 Percentage of responders
|
14.3 Percentage of responders
|
17.9 Percentage of responders
|
29.2 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)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 RA0089.
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
|
30.0 Percentage of responders
|
26.7 Percentage of responders
|
27.3 Percentage of responders
|
21.4 Percentage of responders
|
17.9 Percentage of responders
|
29.2 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)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 RA0089.
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
|
10.0 Percentage of responders
|
20.0 Percentage of responders
|
54.5 Percentage of responders
|
42.9 Percentage of responders
|
32.1 Percentage of responders
|
25.0 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)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 RA0089.
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
|
10.0 Percentage of responders
|
13.3 Percentage of responders
|
18.2 Percentage of responders
|
14.3 Percentage of responders
|
7.1 Percentage of responders
|
16.7 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: 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), total 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. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12 (Study RA0089)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 RA0089.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
|
50.00 Percentage of subjects
|
64.29 Percentage of subjects
|
70.00 Percentage of subjects
|
53.85 Percentage of subjects
|
43.48 Percentage of subjects
|
39.13 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 24 (Study RA0089)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 RA0089.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
|
50.00 Percentage of subjects
|
77.78 Percentage of subjects
|
80.00 Percentage of subjects
|
54.55 Percentage of subjects
|
59.09 Percentage of subjects
|
40.91 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 48 (Study RA0089)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 RA0089.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
|
66.67 Percentage of subjects
|
100.00 Percentage of subjects
|
83.33 Percentage of subjects
|
100.00 Percentage of subjects
|
42.86 Percentage of subjects
|
55.56 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 96 (Study RA0089)DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12 (Study RA0089)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 RA0089.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
|
100.00 Percentage of subjects
|
71.43 Percentage of subjects
|
80.00 Percentage of subjects
|
69.23 Percentage of subjects
|
78.26 Percentage of subjects
|
65.22 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 24 (Study RA0089)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 RA0089.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
|
87.50 Percentage of subjects
|
100.00 Percentage of subjects
|
90.00 Percentage of subjects
|
81.82 Percentage of subjects
|
72.73 Percentage of subjects
|
77.27 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 48 (Study RA0089)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 RA0089.
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Outcome measures
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=14 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
|
66.67 Percentage of subjects
|
100.00 Percentage of subjects
|
100.00 Percentage of subjects
|
100.00 Percentage of subjects
|
71.43 Percentage of subjects
|
77.78 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 96 (Study RA0089)DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-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 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 shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)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 RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
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; MCP, thumb IP, and 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=6 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=4 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=7 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=9 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
|
-72.0000 units on a scale
Standard Deviation 86.13362
|
-108.0256 units on a scale
Standard Deviation 77.85787
|
-95.1667 units on a scale
Standard Deviation 24.41652
|
-75.2870 units on a scale
Standard Deviation 46.83603
|
-94.7363 units on a scale
Standard Deviation 54.63562
|
-99.9744 units on a scale
Standard Deviation 41.83169
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)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; MCP, thumb IP, and 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. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)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 RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (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; MCP, thumb IP, and 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 |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=3 Participants
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=6 Participants
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=4 Participants
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=7 Participants
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=9 Participants
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
|
-75.6667 units on a scale
Standard Deviation 90.23488
|
-130.6923 units on a scale
Standard Deviation 97.08073
|
-125.1667 units on a scale
Standard Deviation 48.85659
|
-93.7870 units on a scale
Standard Deviation 61.23550
|
-113.3077 units on a scale
Standard Deviation 53.87161
|
-127.8633 units on a scale
Standard Deviation 38.49694
|
SECONDARY outcome
Timeframe: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL\]), as per 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; MCP, thumb IP, and PIP joints of the hands; and the knees. 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. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Outcome measures
Outcome data not reported
Adverse Events
RA0083 CDP6038 (Olokizumab) 120 mg q2w
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
RA0083 CDP6038 (Olokizumab) 240 mg q4w
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
RA0083 CDP6038 (Olokizumab) 60 mg q2w
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
RA0083 CDP6038 (Olokizumab) 60 mg q4w
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
RA0083 Placebo
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 participants at risk
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 participants at risk
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 participants at risk
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=15 participants at risk
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 participants at risk
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 participants at risk
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Nervous system disorders
Third nerve paralysis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
Other adverse events
| Measure |
RA0083 CDP6038 (Olokizumab) 120 mg q2w
n=10 participants at risk
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 120 mg q4w
n=15 participants at risk
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 240 mg q4w
n=11 participants at risk
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q2w
n=15 participants at risk
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 CDP6038 (Olokizumab) 60 mg q4w
n=28 participants at risk
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
|
RA0083 Placebo
n=24 participants at risk
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
10.7%
3/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
18.2%
2/11 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
10.7%
3/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
14.3%
4/28 • Number of events 4 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Hypocomplementaemia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Abnormal sensation in eye
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Asthenopia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
14.3%
4/28 • Number of events 5 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gingival swelling
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
10.7%
3/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
30.0%
3/10 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
27.3%
3/11 • Number of events 8 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Chest pain
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Discomfort
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Injection site erythema
|
20.0%
2/10 • Number of events 17 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 4 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 7 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Injection site induration
|
20.0%
2/10 • Number of events 16 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Injection site pruritus
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 4 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Injection site swelling
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Malaise
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
12.5%
3/24 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
12.5%
3/24 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 8 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Immune system disorders
Seasonal allergy
|
20.0%
2/10 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Candida infection
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
10.7%
3/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Endometritis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Furuncle
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
27.3%
3/11 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
20.0%
3/15 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Localised infection
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10 • Number of events 6 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
40.0%
6/15 • Number of events 6 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
18.2%
2/11 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
40.0%
6/15 • Number of events 7 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
32.1%
9/28 • Number of events 12 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
33.3%
8/24 • Number of events 14 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Onychomycosis
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Paronychia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
10.7%
3/28 • Number of events 5 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
27.3%
3/11 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Tinea pedis
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
12.5%
3/24 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
20.0%
3/15 • Number of events 5 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
12.5%
3/24 • Number of events 8 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
2/10 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
20.8%
5/24 • Number of events 5 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
20.8%
5/24 • Number of events 6 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Bacterial test positive
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Complement factor abnormal
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
8.3%
2/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Atlantoaxial instability
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
3.6%
1/28 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 4 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
16.7%
4/24 • Number of events 11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Nervous system disorders
Hyperaesthesia
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
7.1%
2/28 • Number of events 2 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
10.0%
1/10 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/28 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/24 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
9.1%
1/11 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
13.3%
2/15 • Number of events 3 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
10.7%
3/28 • Number of events 5 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/15 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
0.00%
0/11 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
6.7%
1/15 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
14.3%
4/28 • Number of events 4 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
4.2%
1/24 • Number of events 1 • From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
|
Additional Information
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