A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)
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 this study is 208 weeks, followed by approximately 16 weeks of safety and
efficacy follow-up after the administration of the final study agent injection of sirukumab.
Participant safety will be monitored throughout the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The number of participants with cardiovascular serious adverse events (SAEs)
Up to 224 weeks
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
United States: Food and Drug Administration