Status:
COMPLETED
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antir...
Detailed Description
This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two groups of participants at the same time (parallel-group study). The maximum duration of participation in th...
Eligibility Criteria
Inclusion
- Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003
- Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study
Exclusion
- Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003
- Is pregnant
- Has active diverticulitis
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Key Trial Info
Start Date :
August 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
1820 Patients enrolled
Trial Details
Trial ID
NCT01856309
Start Date
August 7 2013
End Date
April 30 2018
Last Update
May 6 2019
Active Locations (197)
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1
Birmingham, Alabama, United States
2
Glendale, Arizona, United States
3
Mesa, Arizona, United States
4
Peoria, Arizona, United States