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Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296711
Recruitment Status : Terminated (Decision to out-license the compound for further development)
First Posted : February 15, 2011
Results First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
R-Pharm
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: CDP6038 (olokizumab)
Enrollment 190
Recruitment Details The present study was an open-label extension to study RA0056 (NCT01242488). Subjects completing the 12-week treatment period of study RA0056 had the opportunity to participate in this study. First subject enrolled: 07 March 2011. Early termination: 05 Aug 2013.
Pre-assignment Details 198 subjects completed the parent study RA0056 (NCT01242488); 190 subjects were enrolled in study RA0057. The study was a single treatment study and all subjects received CDP6038 (olokizumab) 120 mg sc q2w, however, some results are also presented according to the previously assigned treatment arms of the parent study RA0056.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Period Title: Overall Study
Started 20 20 21 20 17 16 40 36
Completed 4 12 8 7 7 5 9 15
Not Completed 16 8 13 13 10 11 31 21
Reason Not Completed
Adverse Event             3             1             4             3             1             6             11             3
Lack of Efficacy             1             4             1             1             1             0             2             3
Lost to Follow-up             0             0             1             1             2             0             4             2
Protocol Violation             0             0             0             1             1             0             0             0
Withdrawal by Subject             4             2             2             1             1             1             2             1
Study termination             8             1             5             4             4             4             8             10
Continued elevated liver enzymes             0             0             0             1             0             0             0             0
Methotrexate discontinued             0             0             0             1             0             0             0             0
Investigator discretion             0             0             0             0             0             0             1             0
Other             0             0             0             0             0             0             1             0
Required restricted steroid injections             0             0             0             0             0             0             1             0
Ongoing missed appointments             0             0             0             0             0             0             1             0
Failure to comply with visits             0             0             0             0             0             0             0             1
Patient decision due to transport             0             0             0             0             0             0             0             1
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w Total
Hide Arm/Group Description CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 20 20 21 20 17 16 40 36 190
Hide Baseline Analysis Population Description
Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0057.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 20 participants 17 participants 16 participants 40 participants 36 participants 190 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  85.0%
16
  80.0%
17
  81.0%
14
  70.0%
13
  76.5%
14
  87.5%
27
  67.5%
29
  80.6%
147
  77.4%
>=65 years
3
  15.0%
4
  20.0%
4
  19.0%
6
  30.0%
4
  23.5%
2
  12.5%
13
  32.5%
7
  19.4%
43
  22.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 20 participants 17 participants 16 participants 40 participants 36 participants 190 participants
Female
17
  85.0%
17
  85.0%
19
  90.5%
16
  80.0%
14
  82.4%
14
  87.5%
33
  82.5%
31
  86.1%
161
  84.7%
Male
3
  15.0%
3
  15.0%
2
   9.5%
4
  20.0%
3
  17.6%
2
  12.5%
7
  17.5%
5
  13.9%
29
  15.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 20 participants 17 participants 16 participants 40 participants 36 participants 190 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.0%
1
   5.0%
3
  14.3%
2
  10.0%
1
   5.9%
4
  25.0%
3
   7.5%
4
  11.1%
19
  10.0%
White
19
  95.0%
18
  90.0%
18
  85.7%
18
  90.0%
16
  94.1%
12
  75.0%
35
  87.5%
31
  86.1%
167
  87.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.0%
1
   2.8%
4
   2.1%
1.Primary Outcome
Title Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Hide Description Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
Time Frame From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Count of Participants
Unit of Measure: Participants
17
  85.0%
20
 100.0%
19
  90.5%
18
  90.0%
15
  88.2%
15
  93.8%
39
  97.5%
35
  97.2%
2.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) to Week 12 of Study RA0057
Hide Description DAS28(CRP) was calculated using the tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, the Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 13 17 19 15 15 15 32 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.2809  (1.45737) -2.2485  (1.39384) -2.5123  (1.39667) -2.2230  (1.17572) -1.6957  (0.67335) -2.1735  (1.56606) -2.3727  (1.41421) -2.4710  (1.43947)
3.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 13 14 19 10 13 14 31 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.6441  (1.46566) 1.46566  (1.17637) -2.5811  (1.40191) -2.5999  (1.16812) -1.7189  (0.87218) -2.4221  (1.37341) -2.1484  (1.34676) -2.7624  (1.47841)
4.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 10 12 13 10 12 10 20 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3257  (1.07427) -2.2498  (1.66580) -2.5277  (1.56763) -2.7050  (0.96160) -2.3824  (0.79065) -2.1501  (0.64141) -2.2403  (1.47765) -2.7611  (1.31329)
5.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 3 1 3 2 3 2 2 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2427  (1.74642) -3.5767 -2.5985  (2.16200) -3.0999  (0.02877) -1.7516  (2.03992) -2.6451  (0.96108) -3.3173  (3.23508) -3.7982  (1.23889)
6.Secondary Outcome
Title The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
Hide Description ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
40.0 50.0 76.2 35.0 58.8 50.0 47.5 52.8
7.Secondary Outcome
Title The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
Hide Description ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
40.0 50.0 66.7 30.0 47.1 62.5 42.5 63.9
8.Secondary Outcome
Title The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
Hide Description ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
40.0 30.0 42.9 35.0 47.1 43.8 25.0 50.0
9.Secondary Outcome
Title The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
Hide Description ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
15.0 5.0 9.5 5.0 11.8 12.5 2.5 13.9
10.Secondary Outcome
Title The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
Hide Description ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
25.0 15.0 33.3 15.0 17.6 18.8 27.5 38.9
11.Secondary Outcome
Title The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
Hide Description ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
20.0 20.0 33.3 15.0 11.8 43.8 25.0 41.7
12.Secondary Outcome
Title The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
Hide Description ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
10.0 15.0 28.6 20.0 35.3 31.3 15.0 33.3
13.Secondary Outcome
Title The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
Hide Description ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
10.0 5.0 4.8 0.0 11.8 6.3 2.5 8.3
14.Secondary Outcome
Title The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
Hide Description ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
10.0 5.0 19.0 5.0 0.0 18.8 15.0 13.9
15.Secondary Outcome
Title The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
Hide Description ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
10.0 15.0 19.0 5.0 0.0 12.5 10.0 25.0
16.Secondary Outcome
Title The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
Hide Description ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
5.0 5.0 23.8 10.0 11.8 6.3 10.0 13.9
17.Secondary Outcome
Title The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
Hide Description ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time Frame Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of responders
5.0 0.0 4.8 0.0 5.9 0.0 2.5 5.6
18.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Time Frame Week 12 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
25.0 30.0 38.1 25.0 0 18.8 25.0 25.0
19.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Time Frame Week 24 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
25.0 35.0 33.3 25.0 17.6 12.5 20.0 33.3
20.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Time Frame Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
20.0 30.0 23.8 20.0 29.4 12.5 15.0 22.2
21.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Time Frame Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
10.0 5.0 9.5 5.0 11.8 0 2.5 8.3
22.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to (<=) 3.2 implies low disease activity.
Time Frame Week 12 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
35.6 40.0 52.4 30.0 17.6 25.0 35.0 44.4
23.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
Time Frame Week 24 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
35.0 40.0 38.1 30.0 23.5 37.5 35.0 50.0
24.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
Time Frame Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
25.0 45.0 23.8 25.0 29.4 18.8 22.5 47.2
25.Secondary Outcome
Title Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057
Hide Description DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
Time Frame Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 20 20 21 20 17 16 40 36
Measure Type: Number
Unit of Measure: Percentage of subjects
15.0 5.0 9.5 5.0 11.8 0 2.5 11.1
26.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057
Hide Description CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 10 13 14 10 12 10 20 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-80.1000  (53.28425) -65.3373  (63.72098) -94.3335  (61.48562) -80.8077  (57.91606) -79.9231  (30.09849) -84.8378  (33.77586) -74.3315  (53.99274) -83.4950  (42.48396)
27.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057
Hide Description CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
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Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 3 1 3 2 3 2 2 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
-108.0000  (66.77574) -118.0000 -89.0000  (55.97321) -74.3846  (4.78657) -74.0000  (55.74944) -90.5000  (13.43503) -104.5000  (126.57211) -107.4000  (51.52960)
28.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057
Hide Description SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre [mg/dL]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
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Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 10 13 13 10 12 10 20 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-92.1000  (62.22799) -75.8757  (74.37825) -104.6668  (80.47988) -92.4077  (55.42723) -87.7564  (28.41084) -112.5378  (52.99896) -87.5815  (59.26016) -107.4080  (60.17362)
29.Secondary Outcome
Title Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057
Hide Description SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre [mg/dL]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Time Frame Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, Number of Participants Analyzed included those participants who were evaluable for the assessment.
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description:
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Overall Number of Participants Analyzed 3 1 3 2 3 2 2 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
-111.0000  (68.78953) -125.0000 -90.3333  (56.04760) -91.8846  (29.53531) -75.3333  (56.09219) -147.5000  (77.07464) -128.0000  (147.07821) -143.4000  (80.28574)
Time Frame From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Adverse Event Reporting Description Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
 
Arm/Group Title RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Hide Arm/Group Description CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056). CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks. Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
All-Cause Mortality
RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)      0/21 (0.00%)      0/20 (0.00%)      0/17 (0.00%)      1/16 (6.25%)      1/40 (2.50%)      0/36 (0.00%)    
Hide Serious Adverse Events
RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/20 (15.00%)      6/20 (30.00%)      6/21 (28.57%)      7/20 (35.00%)      5/17 (29.41%)      3/16 (18.75%)      14/40 (35.00%)      4/36 (11.11%)    
Cardiac disorders                 
Acute myocardial infarction * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Bradycardia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Coronary artery disease * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Myocardial infarction * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Angina pectoris * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Endocrine disorders                 
Goitre * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Gastrointestinal disorders                 
Gastric perforation * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
General disorders                 
Chest pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 2/20 (10.00%)  2 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Chest discomfort * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Unevaluable event * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Multi-organ failure * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Infections and infestations                 
Cellulitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Staphylococcal infection * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Localised infection * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Appendicitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Gangrene * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Subcutaneous abscess * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Diverticulitis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Pyelonephritis acute * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Diabetic foot infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Pneumonia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Urinary tract infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Incision site cellulitis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Furuncle * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Necrotising fasciitis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Sepsis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Injury, poisoning and procedural complications                 
Rib fracture * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Upper limb fracture * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Hip fracture * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Road traffic accident * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Investigations                 
Blood lactate dehydrogenase increased * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Hepatic enzyme increased * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Cervical spinal stenosis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Arthralgia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Musculoskeletal pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Back pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Bladder cancer * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Basal cell carcinoma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
B-cell lymphoma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Renal cell carcinoma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Basosquamous carcinoma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Squamous cell carcinoma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders                 
Transient ischaemic attack * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Psychiatric disorders                 
Depression suicidal * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Anxiety disorder * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Depression * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Renal and urinary disorders                 
Renal failure acute * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Pulmonary infarction * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Asthma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Chronic obstructive pulmonary disease * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Emphysema * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Pulmonary fibrosis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Laryngospasm * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Rash maculo-papular * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Surgical and medical procedures                 
Cholecystectomy * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Spinal fusion surgery * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Vascular disorders                 
Haematoma * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Hypertension * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Femoral artery occlusion * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Deep vein thrombosis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
1
Term from vocabulary, MedDRA 16.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/20 (80.00%)      20/20 (100.00%)      18/21 (85.71%)      17/20 (85.00%)      15/17 (88.24%)      15/16 (93.75%)      36/40 (90.00%)      35/36 (97.22%)    
Blood and lymphatic system disorders                 
Neutropenia * 1  1/20 (5.00%)  1 1/20 (5.00%)  2 2/21 (9.52%)  2 0/20 (0.00%)  0 0/17 (0.00%)  0 2/16 (12.50%)  6 1/40 (2.50%)  1 0/36 (0.00%)  0
Leukopenia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 2/16 (12.50%)  6 0/40 (0.00%)  0 0/36 (0.00%)  0
Anaemia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 1/36 (2.78%)  1
Macrocytosis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Monocytopenia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Ear and labyrinth disorders                 
Tinnitus * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Vertigo * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/21 (9.52%)  3 1/20 (5.00%)  1 0/17 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 0/36 (0.00%)  0
Ear pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Eye disorders                 
Eye pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Vision blurred * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Conjunctivitis * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 0/36 (0.00%)  0
Gastrointestinal disorders                 
Diarrhoea * 1  2/20 (10.00%)  2 1/20 (5.00%)  1 3/21 (14.29%)  4 1/20 (5.00%)  1 1/17 (5.88%)  1 0/16 (0.00%)  0 7/40 (17.50%)  8 4/36 (11.11%)  4
Flatulence * 1  2/20 (10.00%)  2 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Vomiting * 1  1/20 (5.00%)  1 3/20 (15.00%)  3 3/21 (14.29%)  3 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 3/40 (7.50%)  3 1/36 (2.78%)  4
Constipation * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/36 (5.56%)  2
Haemorrhoids * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Nausea * 1  0/20 (0.00%)  0 1/20 (5.00%)  2 3/21 (14.29%)  4 1/20 (5.00%)  5 0/17 (0.00%)  0 1/16 (6.25%)  1 5/40 (12.50%)  5 2/36 (5.56%)  2
Abdominal pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 3/36 (8.33%)  3
Periodontal disease * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Hiatus hernia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
General disorders                 
Fatigue * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 0/17 (0.00%)  0 2/16 (12.50%)  2 4/40 (10.00%)  4 2/36 (5.56%)  2
Injection site reaction * 1  2/20 (10.00%)  2 2/20 (10.00%)  3 0/21 (0.00%)  0 1/20 (5.00%)  1 2/17 (11.76%)  2 0/16 (0.00%)  0 6/40 (15.00%)  8 8/36 (22.22%)  14
Oedema peripheral * 1  1/20 (5.00%)  2 0/20 (0.00%)  0 2/21 (9.52%)  3 1/20 (5.00%)  1 1/17 (5.88%)  1 0/16 (0.00%)  0 3/40 (7.50%)  3 2/36 (5.56%)  3
Injection site erythema * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  9 1/16 (6.25%)  2 2/40 (5.00%)  4 2/36 (5.56%)  2
Injection site bruising * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1 1/17 (5.88%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 1/36 (2.78%)  2
Injection site pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  11 1/17 (5.88%)  1 1/16 (6.25%)  16 3/40 (7.50%)  18 3/36 (8.33%)  21
Injection site induration * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Injection site rash * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Vessel puncture site haematoma * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Injection site swelling * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  2 0/40 (0.00%)  0 1/36 (2.78%)  1
Pyrexia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/36 (5.56%)  2
Pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 2/36 (5.56%)  2
Immune system disorders                 
Seasonal allergy * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 2/21 (9.52%)  2 2/20 (10.00%)  2 0/17 (0.00%)  0 1/16 (6.25%)  1 2/40 (5.00%)  2 1/36 (2.78%)  1
Infections and infestations                 
Bronchitis * 1  1/20 (5.00%)  1 2/20 (10.00%)  2 3/21 (14.29%)  3 3/20 (15.00%)  4 1/17 (5.88%)  1 3/16 (18.75%)  3 5/40 (12.50%)  7 3/36 (8.33%)  4
Cellulitis * 1  1/20 (5.00%)  1 2/20 (10.00%)  4 1/21 (4.76%)  1 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 2/36 (5.56%)  3
Ear infection * 1  1/20 (5.00%)  1 2/20 (10.00%)  2 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 2/40 (5.00%)  2 1/36 (2.78%)  1
Herpes zoster * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/21 (4.76%)  1 1/20 (5.00%)  1 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Influenza * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 3/40 (7.50%)  3 2/36 (5.56%)  2
Nasopharyngitis * 1  1/20 (5.00%)  3 6/20 (30.00%)  10 0/21 (0.00%)  0 1/20 (5.00%)  1 2/17 (11.76%)  2 2/16 (12.50%)  2 3/40 (7.50%)  3 3/36 (8.33%)  5
Oral herpes * 1  1/20 (5.00%)  2 1/20 (5.00%)  3 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/36 (5.56%)  2
Otitis media * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 2/16 (12.50%)  2 1/40 (2.50%)  1 0/36 (0.00%)  0
Sinusitis * 1  1/20 (5.00%)  1 3/20 (15.00%)  3 0/21 (0.00%)  0 2/20 (10.00%)  2 1/17 (5.88%)  1 2/16 (12.50%)  3 4/40 (10.00%)  4 6/36 (16.67%)  7
Upper respiratory tract infection * 1  3/20 (15.00%)  3 3/20 (15.00%)  3 9/21 (42.86%)  12 2/20 (10.00%)  2 4/17 (23.53%)  6 3/16 (18.75%)  3 7/40 (17.50%)  10 5/36 (13.89%)  9
Urinary tract infection * 1  2/20 (10.00%)  2 1/20 (5.00%)  3 6/21 (28.57%)  24 2/20 (10.00%)  2 2/17 (11.76%)  3 3/16 (18.75%)  5 5/40 (12.50%)  12 5/36 (13.89%)  11
Gastroenteritis viral * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 2/21 (9.52%)  2 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 2/40 (5.00%)  2 1/36 (2.78%)  3
Pharyngitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 2/17 (11.76%)  2 1/16 (6.25%)  1 2/40 (5.00%)  2 1/36 (2.78%)  1
Pneumonia * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 0/36 (0.00%)  0
Fungal infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  2 1/20 (5.00%)  1 1/17 (5.88%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Skin infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Staphylococcal infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/36 (5.56%)  3
Respiratory tract infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Vaginitis bacterial * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 2/17 (11.76%)  2 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Staphylococcal abscess * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Viral infection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  2 2/36 (5.56%)  2
Injury, poisoning and procedural complications                 
Arthropod bite * 1  0/20 (0.00%)  0 3/20 (15.00%)  3 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 1/36 (2.78%)  2
Contusion * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 1/20 (5.00%)  1 2/17 (11.76%)  4 1/16 (6.25%)  1 2/40 (5.00%)  3 0/36 (0.00%)  0
Limb injury * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/21 (4.76%)  1 0/20 (0.00%)  0 1/17 (5.88%)  1 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Muscle strain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/36 (5.56%)  3
Excoriation * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 2/36 (5.56%)  4
Fall * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 2/20 (10.00%)  5 2/17 (11.76%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 1/36 (2.78%)  1
Wound * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/21 (9.52%)  2 0/20 (0.00%)  0 0/17 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 0/36 (0.00%)  0
Cartilage injury * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Ligament sprain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 2/17 (11.76%)  2 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Upper limb fracture * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0 0/40 (0.00%)  0 0/36 (0.00%)  0
Meniscus injury * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1 0/40 (0.00%)  0 0/36 (0.00%)  0
Investigations                 
Alanine aminotransferase increased