CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,820 enrolled
Drug / intervention
Sirukumab 100 mg +2 moredrug
Likely dose
Sirukumab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01856309
NCT01856309Phase 3Completed
CompareCT.gov

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)

Janssen Research & Development, LLC·interventional·Posted May 17, 2013·Updated May 6, 2019

In Brief

A Phase 3 clinical trial evaluating Sirukumab 100 mg, Sirukumab 50 mg, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 1,820 participants across 197 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, France, Germany, Japan, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 17, 2013
Enrollment StartAug 7, 2013
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.1 years ago

Interventions

Sirukumab 100 mgdrug

Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.

Sirukumab 50 mgdrug

Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.

Placebodrug

Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.