Study Stopped
Decision to out-license the compound for further development
Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056
2 other identifiers
interventional
190
3 countries
55
Brief Summary
The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis who completed study RA0056 (NCT01242488).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Mar 2011
Typical duration for phase_2 rheumatoid-arthritis
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedStudy Start
First participant enrolled
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2013
CompletedResults Posted
Study results publicly available
April 14, 2022
CompletedApril 14, 2022
March 1, 2022
2.2 years
February 14, 2011
January 27, 2017
March 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
Secondary Outcomes (28)
Change From Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) to Week 12 of Study RA0057
Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
- +23 more secondary outcomes
Study Arms (1)
CDP6038 (olokizumab)
EXPERIMENTALInterventions
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
Eligibility Criteria
You may qualify if:
- Subject completed the RA0056 study (Week 12 Visit)
- Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of administration for at least 12 weeks
- Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
- Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 (olokizumab) dose
- Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038 (olokizumab)
You may not qualify if:
- Subject has an ongoing serious adverse event from the RA0056 study
- Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
- Subject has evidence of active or latent tuberculosis
- Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
- Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (\~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES, Inc.lead
- R-Pharmcollaborator
Study Sites (55)
166
Mesa, Arizona, United States
154
Phoenix, Arizona, United States
118
Scottsdale, Arizona, United States
103
Hot Springs, Arkansas, United States
127
Covina, California, United States
148
La Jolla, California, United States
184
Long Beach, California, United States
177
Los Angeles, California, United States
104
Palo Alto, California, United States
129
Santa Maria, California, United States
164
Upland, California, United States
141
Hamden, Connecticut, United States
111
Lewes, Delaware, United States
151
DeBary, Florida, United States
114
Jupiter, Florida, United States
157
Tampa, Florida, United States
183
Tampa, Florida, United States
116
Idaho Falls, Idaho, United States
160
Moline, Illinois, United States
168
Springfield, Illinois, United States
133
Cedar Rapids, Iowa, United States
172
Kansas City, Kansas, United States
185
Saint Clair Shores, Michigan, United States
112
St Louis, Missouri, United States
134
St Louis, Missouri, United States
102
Lincoln, Nebraska, United States
171
Freehold, New Jersey, United States
152
Toms River, New Jersey, United States
174
Brooklyn, New York, United States
170
Charlotte, North Carolina, United States
150
Cincinnati, Ohio, United States
100
Dayton, Ohio, United States
110
Oklahoma City, Oklahoma, United States
165
Duncansville, Pennsylvania, United States
105
Nashville, Tennessee, United States
135
Austin, Texas, United States
128
Dallas, Texas, United States
126
Houston, Texas, United States
132
Houston, Texas, United States
138
Houston, Texas, United States
181
Houston, Texas, United States
145
Mesquite, Texas, United States
143
Nassau Bay, Texas, United States
122
San Antonio, Texas, United States
144
Tomball, Texas, United States
142
Victoria, Texas, United States
139
Chesapeake, Virginia, United States
175
Tacoma, Washington, United States
136
Beckley, West Virginia, United States
167
Clarksburg, West Virginia, United States
401
Brussels, Belgium
400
Liège, Belgium
206
Essex, United Kingdom
208
Southampton, United Kingdom
209
Torquay, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The clinical trial was terminated early as a result of a strategic UCB decision to out-license the study drug for further development. As a result, only small numbers of subjects were still in the study past the Week 48 time point.
Results Point of Contact
- Title
- Clin Trial Reg & Results Disclosure
- Organization
- UCB BIOSCIENCES GmbH
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Genovese, Dr
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
March 7, 2011
Primary Completion
May 1, 2013
Study Completion
August 5, 2013
Last Updated
April 14, 2022
Results First Posted
April 14, 2022
Record last verified: 2022-03