The Long-term Safety and Efficacy of CDP6038 (Olokizumab)... | NCT01533714 | Trialant
NCT01533714
Sponsor
UCB BIOSCIENCES, Inc.
Status
Terminated
Last Update Posted
May 20, 2022Actual
Enrollment
103Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
CDP6038 (olokizumab)
Countries
Japan
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01533714
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RA0089
Secondary IDs
Not provided
Brief Title
The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
Official Title
Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083
Acronym
Not provided
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
May 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
Jan 26, 2012Actual
Primary Completion Date
Nov 27, 2013Actual
Completion Date
Nov 29, 2013Actual
First Submitted Date
Feb 10, 2012
First Submission Date that Met QC Criteria
Feb 10, 2012
First Posted Date
Feb 15, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
May 5, 2016
Results First Submitted that Met QC Criteria
Feb 28, 2022
Results First Posted Date
May 17, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 25, 2014
Certification/Extension First Submitted that Passed QC Review
Aug 27, 2014
Certification/Extension First Posted Date
Aug 29, 2014Estimated
Last Update Submitted Date
May 18, 2022
Last Update Posted Date
May 20, 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 (RA) who completed study RA0083 [NCT01463059].
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 2 weeks (q2w), for the treatment of active RA.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
Monoclonal antibody
Interleukin-6
Olokizumab
CDP6038
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
103Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CDP6038 (olokizumab)
Experimental
CDP6038 (olokizumab) 120 mg: subcutaneous injections at q2w (every two weeks). RA0089 is a single arm study, however, analysis will be presented according to the original treatment arms of the parent study NCT01463059 (RA0083).
Biological: CDP6038 (olokizumab)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CDP6038 (olokizumab)
Biological
Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
CDP6038 (olokizumab)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Total 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 RA0089 and within 30 days after the last dose.
From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: •TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (>) 5.1 correspond with active disease, scores less than (<) 3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Completed the RA0083 [NCT01463059] study (Week 12 Visit)
Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059], 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 2 acceptable methods of contraception
Exclusion Criteria:
Have an ongoing SAE from the RA0083 [NCT01463059] study
Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
Have evidence of active or latent tuberculosis (TB)
Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
Subject has planned surgery during the first 12 weeks of the study
Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 [NCT01463059] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 [NCT01463059]
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 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
Tsutomu Takeuchi, Professor
Keio University
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
102
Chiba
Japan
114
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
105 subjects completed the parent Study RA0083 (NCT01463059); 103 subjects were enrolled in Study RA0089.
Recruitment Details
The present study was an open-label extension to study RA0083 (NCT01463059). Subjects completing the 12-week treatment period of study RA0083 had the opportunity to participate in this study. First subject enrolled: 26 January 2012. Last subject completed: 27 November 2013.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
FG001
RA0083 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
RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
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 RA0083) and Week 12 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed.
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported.
Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Fukuoka
Japan
115
Fukuoka
Japan
113
Hiroshima
Japan
120
Kakogawa
Japan
118
Kumamoto
Japan
116
Kurume
Japan
122
Matsuyama
Japan
107
Nagaoka
Japan
110
Nagoya
Japan
103
Narita
Japan
112
Okayama
Japan
119
ÅŒita
Japan
100
Sapporo
Japan
117
Sasebo
Japan
123
Tokyo
Japan
101
Tomakomai
Japan
108
Tonami
Japan
111
Tsu
Japan
105
Yokohama
Japan
104
Yotukaido
Japan
200
Daejeon
South Korea
201
Junggu
South Korea
202
Seongdong-Gu
South Korea
203
Seoul
South Korea
204
Seoul
South Korea
301
Taichung
Taiwan
306
Taichung
Taiwan
307
Taichung
Taiwan
302
Taipei
Taiwan
308
Taipei
Taiwan
309
Taipei
Taiwan
CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
FG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
FG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
FG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
FG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
FG00010 subjects
FG00115 subjects
FG00211 subjects
FG00315 subjects
FG00428 subjects
FG00524 subjects
COMPLETED
FG00010 subjects
FG00112 subjects
FG0027 subjects
FG00311 subjects
FG00421 subjects
FG00521 subjects
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0047 subjects
FG0053 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Exclusion criteria
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Positive for purified protein derivative
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal criteria
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Ineligibility reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0089.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
BG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
BG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
BG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
BG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
BG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00115
BG00211
BG00315
BG00428
BG00524
BG006103
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
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
BG0007
BG00112
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
Total 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 RA0089 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 RA0089.
Posted
Count of Participants
Participants
From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0008
OG00113
OG00210
OG003
Secondary
Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: •TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (>) 5.1 correspond with active disease, scores less than (<) 3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Full Analysis Set (FAS) included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
Secondary
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
Secondary
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
Secondary
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed.
Not Posted
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Participants
Secondary
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Participants
Secondary
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Participants
Secondary
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of responders
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Participants
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of subjects
Week 12 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of subjects
Week 24 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of subjects
Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Week 96 (Study RA0089)
Participants
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of subjects
Week 12 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of subjects
Week 24 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
Posted
Number
Percentage of subjects
Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Week 96 (Study RA0089)
Participants
Secondary
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
OG001
Secondary
Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Participants
Secondary
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
ID
Title
Description
OG000
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
Secondary
Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Not Posted
Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Participants
Secondary
Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Not Posted
Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Participants
Secondary
Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Not Posted
Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Participants
Time Frame
From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Description
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 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
RA0083 CDP6038 (Olokizumab) 120 mg q2w
CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083).
0
10
1
10
8
10
EG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
0
15
0
15
13
15
EG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
0
11
2
11
10
11
EG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
0
15
2
15
12
15
EG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
0
28
5
28
25
28
EG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
0
24
4
24
21
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected15 at risk
EG0040 events0 affected28 at risk
EG0050 events0 affected24 at risk
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Avulsion fracture
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Third nerve paralysis
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Spondylitic myelopathy
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coagulopathy
Blood and lymphatic system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected15 at risk
EG0040 events0 affected28 at risk
EG0050 events0 affected24 at risk
Hypocomplementaemia
Blood and lymphatic system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Asthenopia
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Cataract
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Dry eye
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Gingival swelling
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Ischaemic enteritis
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0003 events3 affected10 at risk
EG0012 events2 affected15 at risk
EG0028 events3 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Chest pain
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Discomfort
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Injection site erythema
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG00017 events2 affected10 at risk
EG0013 events2 affected15 at risk
EG0024 events1 affected11 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Injection site induration
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG00016 events2 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Injection site pruritus
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Injection site reaction
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0014 events2 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Injection site swelling
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0022 events1 affected11 at risk
EG003
Malaise
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0028 events1 affected11 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Candida infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Endometritis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0023 events3 affected11 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0013 events3 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Localised infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0006 events3 affected10 at risk
EG0016 events6 affected15 at risk
EG0022 events2 affected11 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Oral herpes
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected15 at risk
EG0023 events3 affected11 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0015 events3 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected10 at risk
EG0013 events2 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Nail avulsion
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Bacterial test positive
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Complement factor abnormal
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
White blood cell count decreased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Atlantoaxial instability
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Spinal ligament ossification
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0004 events2 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0013 events2 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0022 events2 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0023 events1 affected11 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected15 at risk
EG0021 events1 affected11 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected15 at risk
EG0021 events1 affected11 at risk
EG003
The clinical trial was terminated early following a strategic UCB decision to out-license the study drug for further development. No data were collected at Week 96 or beyond; no analysis was performed on study drug plasma levels or antibodies.
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
UCB
Cares
001-844-599-2273
UCBCares@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
0 subjects
FG0051 subjects
1 subjects
FG0050 subjects
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
3 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0007
BG00111
BG00210
BG00313
BG00423
BG00518
BG00682
>=65 years
BG0003
BG0014
BG0021
BG0032
BG0045
BG0056
BG00621
9
BG00312
BG00427
BG00521
BG00688
Male
BG0003
BG0013
BG0022
BG0033
BG0041
BG0053
BG00615
15
OG00428
OG00524
12
OG00425
OG00522
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00114
OG00210
OG00313
OG00423
OG00523
Title
Denominators
Categories
Title
Measurements
OG000-2.9618± 1.05692
OG001-2.5358± 1.11550
OG002-2.9758± 1.23346
OG003-2.7948± 1.28792
OG004-2.6837± 0.80614
OG005-2.5902± 1.06296
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG0008
OG0019
OG00210
OG00311
OG00422
OG00522
Title
Denominators
Categories
Title
Measurements
OG000-2.6916± 0.75807
OG001-3.3277± 1.05841
OG002-3.3523± 0.74516
OG003-2.8884± 1.43276
OG004-3.0176± 0.82217
OG005-2.8235± 0.99271
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0034
OG0047
OG0059
Title
Denominators
Categories
Title
Measurements
OG000-2.6243± 1.52735
OG001-3.2720± 0.97343
OG002-3.2397± 0.85356
OG003-2.9625± 1.16236
OG004-2.4750± 1.31771
OG005-3.2211± 0.45471
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG00160.0
OG00281.8
OG00371.4
OG00464.3
OG00570.8
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00060.0
OG00146.7
OG00281.8
OG00357.1
OG00471.4
OG00566.7
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00113.3
OG00254.5
OG00321.4
OG00421.4
OG00533.3
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00070.0
OG00140.0
OG00254.5
OG00342.9
OG00442.9
OG00550.0
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00140.0
OG00263.6
OG00357.1
OG00442.9
OG00545.8
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00113.3
OG00245.5
OG00314.3
OG00417.9
OG00529.2
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00030.0
OG00126.7
OG00227.3
OG00321.4
OG00417.9
OG00529.2
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG00120.0
OG00254.5
OG00342.9
OG00432.1
OG00525.0
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG00113.3
OG00218.2
OG00314.3
OG0047.1
OG00516.7
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00050.00
OG00164.29
OG00270.00
OG00353.85
OG00443.48
OG00539.13
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00050.00
OG00177.78
OG00280.00
OG00354.55
OG00459.09
OG00540.91
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00066.67
OG001100.00
OG00283.33
OG003100.00
OG00442.86
OG00555.56
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG000100.00
OG00171.43
OG00280.00
OG00369.23
OG00478.26
OG00565.22
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00087.50
OG001100.00
OG00290.00
OG00381.82
OG00472.73
OG00577.27
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG00010
OG00115
OG00211
OG00314
OG00428
OG00524
Title
Denominators
Categories
Title
Measurements
OG00066.67
OG001100.00
OG002100.00
OG003100.00
OG00471.43
OG00577.78
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0034
OG0047
OG0059
Title
Denominators
Categories
Title
Measurements
OG000-72.0000± 86.13362
OG001-108.0256± 77.85787
OG002-95.1667± 24.41652
OG003-75.2870± 46.83603
OG004-94.7363± 54.63562
OG005-99.9744± 41.83169
OG001
RA0083 CDP6038 (Olokizumab) 120 mg q4w
CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG002
RA0083 CDP6038 (Olokizumab) 240 mg q4w
CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG003
RA0083 CDP6038 (Olokizumab) 60 mg q2w
CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG004
RA0083 CDP6038 (Olokizumab) 60 mg q4w
CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083).
OG005
RA0083 Placebo
Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083)