Open-label Study to Assess the Safety and Efficacy of CDP... | NCT01296711 | Trialant
NCT01296711
Sponsor
UCB BIOSCIENCES, Inc.
Status
Terminated
Last Update Posted
Apr 14, 2022Actual
Enrollment
190Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
CDP6038 (olokizumab)
Countries
United States
Belgium
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01296711
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RA0057
Secondary IDs
ID
Type
Description
Link
2010-022224-77
EudraCT Number
Brief Title
Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
Official Title
A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056
Acronym
Not provided
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Mar 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Decision to out-license the compound for further development
Expanded Access Info
No
Start Date
Mar 7, 2011Actual
Primary Completion Date
May 1, 2013Actual
Completion Date
Aug 5, 2013Actual
First Submitted Date
Feb 14, 2011
First Submission Date that Met QC Criteria
Feb 14, 2011
First Posted Date
Feb 15, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 27, 2017
Results First Submitted that Met QC Criteria
Mar 18, 2022
Results First Posted Date
Apr 14, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 3, 2013
Certification/Extension First Submitted that Passed QC Review
Jun 3, 2013
Certification/Extension First Posted Date
Jun 11, 2013Estimated
Last Update Submitted Date
Mar 18, 2022
Last Update Posted Date
Apr 14, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB BIOSCIENCES, Inc.INDUSTRY
Collaborators
Name
Class
R-Pharm
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis who completed study RA0056 (NCT01242488).
Detailed Description
Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every two weeks, for the treatment of active rheumatoid arthritis.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis
CDP6038
Interleukin-6
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
190Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CDP6038 (olokizumab)
Experimental
Biological: CDP6038 (olokizumab)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CDP6038 (olokizumab)
Biological
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
CDP6038 (olokizumab)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Secondary Outcomes
Measure
Description
Time Frame
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
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject completed the RA0056 study (Week 12 Visit)
Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of administration for at least 12 weeks
Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 (olokizumab) dose
Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038 (olokizumab)
Exclusion Criteria:
Subject has an ongoing serious adverse event from the RA0056 study
Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
Subject has evidence of active or latent tuberculosis
Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent adverse events) which in the Investigator's or Sponsor's judgment would make the subject unsuitable for inclusion in the study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Mark Genovese, Dr
Stanford University
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
166
Mesa
Arizona
United States
154
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
FG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
RA0057 is a single arm study, however, analyses will also be performed according to the original treatment arms of the parent study RA0056 (NCT01242488).
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. 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.
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
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
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.
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Week 12 (Study RA0057)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Week 24 (Study RA0057)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Week 48 (Study RA0057)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
Week 96 (Study RA0057)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to (<=) 3.2 implies low disease activity.
Week 12 (Study RA0057)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
Week 24 (Study RA0057)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
Week 48 (Study RA0057)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
Week 96 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057
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.
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057
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.
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057
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.
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057
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.
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
Phoenix
Arizona
United States
118
Scottsdale
Arizona
United States
103
Hot Springs
Arkansas
United States
127
Covina
California
United States
148
La Jolla
California
United States
184
Long Beach
California
United States
177
Los Angeles
California
United States
104
Palo Alto
California
United States
129
Santa Maria
California
United States
164
Upland
California
United States
141
Hamden
Connecticut
United States
111
Lewes
Delaware
United States
151
DeBary
Florida
United States
114
Jupiter
Florida
United States
157
Tampa
Florida
United States
183
Tampa
Florida
United States
116
Idaho Falls
Idaho
United States
160
Moline
Illinois
United States
168
Springfield
Illinois
United States
133
Cedar Rapids
Iowa
United States
172
Kansas City
Kansas
United States
185
Saint Clair Shores
Michigan
United States
112
St Louis
Missouri
United States
134
St Louis
Missouri
United States
102
Lincoln
Nebraska
United States
171
Freehold
New Jersey
United States
152
Toms River
New Jersey
United States
174
Brooklyn
New York
United States
170
Charlotte
North Carolina
United States
150
Cincinnati
Ohio
United States
100
Dayton
Ohio
United States
110
Oklahoma City
Oklahoma
United States
165
Duncansville
Pennsylvania
United States
105
Nashville
Tennessee
United States
135
Austin
Texas
United States
128
Dallas
Texas
United States
126
Houston
Texas
United States
132
Houston
Texas
United States
138
Houston
Texas
United States
181
Houston
Texas
United States
145
Mesquite
Texas
United States
143
Nassau Bay
Texas
United States
122
San Antonio
Texas
United States
144
Tomball
Texas
United States
142
Victoria
Texas
United States
139
Chesapeake
Virginia
United States
175
Tacoma
Washington
United States
136
Beckley
West Virginia
United States
167
Clarksburg
West Virginia
United States
401
Brussels
Belgium
400
Liège
Belgium
206
Essex
United Kingdom
208
Southampton
United Kingdom
209
Torquay
United Kingdom
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.
FG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
FG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
FG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
FG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
FG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
FG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
FG00020 subjects
FG00120 subjects
FG00221 subjects
FG00320 subjects
FG00417 subjects
FG00516 subjects
FG00640 subjects
FG00736 subjects
COMPLETED
FG0004 subjects
FG00112 subjects
FG0028 subjects
FG0037 subjects
FG0047 subjects
FG0055 subjects
FG0069 subjects
FG00715 subjects
NOT COMPLETED
FG00016 subjects
FG0018 subjects
FG00213 subjects
FG00313 subjects
FG00410 subjects
FG00511 subjects
FG00631 subjects
FG00721 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0024 subjects
FG0033 subjects
FG0041 subjects
FG0056 subjects
FG00611 subjects
FG0073 subjects
Lack of Efficacy
FG0001 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Study termination
FG0008 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG004
Continued elevated liver enzymes
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Methotrexate discontinued
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Investigator discretion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Required restricted steroid injections
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ongoing missed appointments
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Failure to comply with visits
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient decision due to transport
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0057.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
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.
BG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
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.
BG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
BG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
BG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
BG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
BG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
BG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00120
BG00221
BG00320
BG00417
BG00516
BG00640
BG00736
BG008190
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00117
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0057.
Posted
Count of Participants
Participants
From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG00017
OG00120
OG00219
OG003
Secondary
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
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
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
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.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
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.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
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.
Posted
Number
Percentage of subjects
Week 12 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
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.
Posted
Number
Percentage of subjects
Week 24 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
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.
Posted
Number
Percentage of subjects
Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
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.
Posted
Number
Percentage of subjects
Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to (<=) 3.2 implies low disease activity.
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.
Posted
Number
Percentage of subjects
Week 12 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
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.
Posted
Number
Percentage of subjects
Week 24 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
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.
Posted
Number
Percentage of subjects
Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
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.
Posted
Number
Percentage of subjects
Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Secondary
Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
ID
Title
Description
OG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
Time Frame
From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
RA0056 CDP6038 (Olokizumab) 120 mg q2w
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.
0
20
3
20
16
20
EG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
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.
0
20
6
20
20
20
EG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056).
0
21
6
21
18
21
EG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
0
20
7
20
17
20
EG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
0
17
5
17
15
17
EG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
1
16
3
16
15
16
EG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
1
40
14
40
36
40
EG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
0
36
4
36
35
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected20 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected16 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected36 at risk
Cellulitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Haematoma
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Localised infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Gangrene
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Femoral artery occlusion
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Incision site cellulitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Spinal fusion surgery
Surgical and medical procedures
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Furuncle
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Sepsis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Basosquamous carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Goitre
Endocrine disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Chest pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Chest discomfort
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Unevaluable event
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Multi-organ failure
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events1 affected20 at risk
EG0022 events2 affected21 at risk
EG0030 events0 affected20 at risk
EG0040 events0 affected17 at risk
EG0056 events2 affected16 at risk
EG0061 events1 affected40 at risk
EG0070 events0 affected36 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Macrocytosis
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Monocytopenia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0023 events2 affected21 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Eye pain
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected20 at risk
EG0024 events3 affected21 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected20 at risk
EG0023 events3 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected20 at risk
EG0024 events3 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected20 at risk
EG0023 events3 affected21 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0014 events2 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Ear infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0003 events1 affected20 at risk
EG00110 events6 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0002 events1 affected20 at risk
EG0013 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Otitis media
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0003 events3 affected20 at risk
EG0013 events3 affected20 at risk
EG00212 events9 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events1 affected20 at risk
EG00224 events6 affected21 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events1 affected21 at risk
EG003
Skin infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Vaginitis bacterial
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Viral infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Blood pressure increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events1 affected21 at risk
EG003
Lipids increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Platelet count decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Mammogram abnormal
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Red cell distribution width increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0006 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events1 affected20 at risk
EG0012 events1 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0004 events3 affected20 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0003 events3 affected20 at risk
EG0013 events2 affected20 at risk
EG0022 events1 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0015 events5 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Tendon calcification
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Rheumatoid nodule
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0005 events1 affected20 at risk
EG0017 events6 affected20 at risk
EG0022 events1 affected21 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Tremor
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Pyuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events2 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0003 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0016 events4 affected20 at risk
EG0023 events3 affected21 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events1 affected21 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Laryngeal mass
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0005 events5 affected20 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected21 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected21 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0004 events3 affected20 at risk
EG0011 events1 affected20 at risk
EG0023 events3 affected21 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Fatigue
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Injection site reaction
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events2 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0023 events2 affected21 at risk
EG003
Injection site erythema
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Injection site bruising
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Injection site pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Injection site induration
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Injection site rash
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Injection site swelling
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
Pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected21 at risk
EG003
The clinical trial was terminated early as a result of a strategic UCB decision to out-license the study drug for further development. As a result, only small numbers of subjects were still in the study past the Week 48 time point.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. The Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Clin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
001-844-599-2273
clinicaltrials@ucb.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000592400
olokizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0062 subjects
FG0073 subjects
2 subjects
FG0050 subjects
FG0064 subjects
FG0072 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
4 subjects
FG0054 subjects
FG0068 subjects
FG00710 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
Between 18 and 65 years
BG00017
BG00116
BG00217
BG00314
BG00413
BG00514
BG00627
BG00729
BG008147
>=65 years
BG0003
BG0014
BG0024
BG0036
BG0044
BG0052
BG00613
BG0077
BG00843
19
BG00316
BG00414
BG00514
BG00633
BG00731
BG008161
Male
BG0003
BG0013
BG0022
BG0034
BG0043
BG0052
BG0067
BG0075
BG00829
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Black or African American
BG0001
BG0011
BG0023
BG0032
BG0041
BG0054
BG0063
BG0074
BG00819
White
BG00019
BG00118
BG00218
BG00318
BG00416
BG00512
BG00635
BG00731
BG008167
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0062
BG0071
BG0084
20
OG00417
OG00516
OG00640
OG00736
18
OG00415
OG00515
OG00639
OG00735
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00013
OG00117
OG00219
OG00315
OG00415
OG00515
OG00632
OG00729
Title
Denominators
Categories
Title
Measurements
OG000-2.2809± 1.45737(1.45737 to )
OG001-2.2485± 1.39384(1.39384 to )
OG002-2.5123± 1.39667(1.39667 to )
OG003-2.2230± 1.17572(1.17572 to )
OG004-1.6957± 0.67335(0.67335 to )
OG005-2.1735± 1.56606(1.56606 to )
OG006-2.3727± 1.41421(1.41421 to )
OG007-2.4710± 1.43947(1.43947 to )
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00013
OG00114
OG00219
OG00310
OG00413
OG00514
OG00631
OG00729
Title
Denominators
Categories
Title
Measurements
OG000-2.6441± 1.46566(1.46566 to )
OG0011.46566± 1.17637(1.17637 to )
OG002-2.5811± 1.40191(1.40191 to )
OG003-2.5999± 1.16812(1.16812 to )
OG004-1.7189± 0.87218(0.87218 to )
OG005-2.4221± 1.37341(1.37341 to )
OG006-2.1484± 1.34676(1.34676 to )
OG007-2.7624± 1.47841(1.47841 to )
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00010
OG00112
OG00213
OG00310
OG00412
OG00510
OG00620
OG00722
Title
Denominators
Categories
Title
Measurements
OG000-2.3257± 1.07427(1.07427 to )
OG001-2.2498± 1.66580(1.66580 to )
OG002-2.5277± 1.56763(1.56763 to )
OG003-2.7050± 0.96160(0.96160 to )
OG004-2.3824± 0.79065(0.79065 to )
OG005-2.1501± 0.64141(0.64141 to )
OG006-2.2403± 1.47765(1.47765 to )
OG007-2.7611± 1.31329(1.31329 to )
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0032
OG0043
OG0052
OG0062
OG0075
Title
Denominators
Categories
Title
Measurements
OG000-3.2427± 1.74642
OG001-3.5767
OG002-2.5985± 2.16200
OG003-3.0999± 0.02877
OG004-1.7516± 2.03992
OG005-2.6451± 0.96108
OG006-3.3173± 3.23508
OG007-3.7982± 1.23889
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00150.0
OG00276.2
OG00335.0
OG00458.8
OG00550.0
OG00647.5
OG00752.8
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00150.0
OG00266.7
OG00330.0
OG00447.1
OG00562.5
OG00642.5
OG00763.9
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00130.0
OG00242.9
OG00335.0
OG00447.1
OG00543.8
OG00625.0
OG00750.0
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00015.0
OG0015.0
OG0029.5
OG0035.0
OG00411.8
OG00512.5
OG0062.5
OG00713.9
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00115.0
OG00233.3
OG00315.0
OG00417.6
OG00518.8
OG00627.5
OG00738.9
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00120.0
OG00233.3
OG00315.0
OG00411.8
OG00543.8
OG00625.0
OG00741.7
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG00115.0
OG00228.6
OG00320.0
OG00435.3
OG00531.3
OG00615.0
OG00733.3
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG0015.0
OG0024.8
OG0030.0
OG00411.8
OG0056.3
OG0062.5
OG0078.3
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG0015.0
OG00219.0
OG0035.0
OG0040.0
OG00518.8
OG00615.0
OG00713.9
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG00115.0
OG00219.0
OG0035.0
OG0040.0
OG00512.5
OG00610.0
OG00725.0
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG0005.0
OG0015.0
OG00223.8
OG00310.0
OG00411.8
OG0056.3
OG00610.0
OG00713.9
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.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG0005.0
OG0010.0
OG0024.8
OG0030.0
OG0045.9
OG0050.0
OG0062.5
OG0075.6
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00130.0
OG00238.1
OG00325.0
OG0040
OG00518.8
OG00625.0
OG00725.0
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00135.0
OG00233.3
OG00325.0
OG00417.6
OG00512.5
OG00620.0
OG00733.3
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00130.0
OG00223.8
OG00320.0
OG00429.4
OG00512.5
OG00615.0
OG00722.2
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG0015.0
OG0029.5
OG0035.0
OG00411.8
OG0050
OG0062.5
OG0078.3
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00035.6
OG00140.0
OG00252.4
OG00330.0
OG00417.6
OG00525.0
OG00635.0
OG00744.4
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00035.0
OG00140.0
OG00238.1
OG00330.0
OG00423.5
OG00537.5
OG00635.0
OG00750.0
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00145.0
OG00223.8
OG00325.0
OG00429.4
OG00518.8
OG00622.5
OG00747.2
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00020
OG00120
OG00221
OG00320
OG00417
OG00516
OG00640
OG00736
Title
Denominators
Categories
Title
Measurements
OG00015.0
OG0015.0
OG0029.5
OG0035.0
OG00411.8
OG0050
OG0062.5
OG00711.1
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00010
OG00113
OG00214
OG00310
OG00412
OG00510
OG00620
OG00723
Title
Denominators
Categories
Title
Measurements
OG000-80.1000± 53.28425(53.28425 to )
OG001-65.3373± 63.72098(63.72098 to )
OG002-94.3335± 61.48562(61.48562 to )
OG003-80.8077± 57.91606(57.91606 to )
OG004-79.9231± 30.09849(30.09849 to )
OG005-84.8378± 33.77586(33.77586 to )
OG006-74.3315± 53.99274(53.99274 to )
OG007-83.4950± 42.48396(42.48396 to )
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0032
OG0043
OG0052
OG0062
OG0075
Title
Denominators
Categories
Title
Measurements
OG000-108.0000± 66.77574
OG001-118.0000
OG002-89.0000± 55.97321
OG003-74.3846± 4.78657
OG004-74.0000± 55.74944
OG005-90.5000± 13.43503
OG006-104.5000± 126.57211
OG007-107.4000± 51.52960
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
Units
Counts
Participants
OG00010
OG00113
OG00213
OG00310
OG00412
OG00510
OG00620
OG00723
Title
Denominators
Categories
Title
Measurements
OG000-92.1000± 62.22799(62.22799 to )
OG001-75.8757± 74.37825(74.37825 to )
OG002-104.6668± 80.47988(80.47988 to )
OG003-92.4077± 55.42723(55.42723 to )
OG004-87.7564± 28.41084(28.41084 to )
OG005-112.5378± 52.99896(52.99896 to )
OG006-87.5815± 59.26016(59.26016 to )
OG007-107.4080± 60.17362(60.17362 to )
OG001
RA0056 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG002
RA0056 CDP6038 (Olokizumab) 240 mg q2w
CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG003
RA0056 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG004
RA0056 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG005
RA0056 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG006
RA0056 Placebo
Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
OG007
RA0056 Tocilizumab 8 mg/kg q4w
Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.