Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

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 antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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