Overview

This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatments sirukumab 100 mg, sirukumab 50 mg, placebo
Phase phase 3
Sponsor Janssen Research & Development, LLC
Collaborator GlaxoSmithKline
Start date August 2013
End date November 2019
Trial size 1820 participants
Trial identifier NCT01856309, 2012-001176-10, CNTO136ARA3004, CR102023

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
sirukumab 100 mg
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.
(Experimental)
sirukumab 50 mg
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.
placebo
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.

Primary Outcomes

Measure
The number of participants with cardiovascular serious adverse events (SAEs)
time frame: Up to 224 weeks
The number of participants with malignancies
time frame: Up to 224 weeks
The number of participants with serious infections
time frame: Up to 224 weeks
The number of participants with gastrointestinal perforations
time frame: Up to 224 weeks

Secondary Outcomes

Measure
Observations of laboratory parameters of interest (neutrophils, platelets, hepatobiliary parameters, and lipid parameters)
time frame: Up to 224 weeks
Summary of toxicity grading
time frame: Up to 224 weeks
Proportion of participants who achieve ACR 20 response
time frame: Up to 208 weeks
Proportion of participants who achieve ACR 50 response
time frame: Up to 208 weeks
Proportion of participants who achieve ACR 70 response
time frame: Up to 208 weeks
Proportion of participants with DAS28 (CRP) response
time frame: Up to 208 weeks
Proportion of participants with DAS28 (CRP) remission
time frame: Up to 208 weeks
Change from baseline in DAS28 (CRP)
time frame: Up to 208 weeks
Proportion of participants with SDAI-based ACR/EULAR remission
time frame: Up to 208 weeks
Proportion of participants with Boolean-based ACR/EULAR remission
time frame: Up to 208 weeks
Change from baseline in SDAI
time frame: Up to 208 weeks
Change from baseline in CDAI
time frame: Up to 208 weeks
Change from baseline in HAQ-DI
time frame: Up to 208 weeks
Proportion of HAQ-DI responders (ie, those who have a change from baseline of > 0.22 in HAQ-DI score)
time frame: Up to 208 weeks
Change from baseline in Physical Component Score (PCS)
time frame: Up to 208 weeks
Change from baseline in Mental Component Score (MCS)
time frame: Up to 208 weeks
Change from baseline in domain scores of 36-item short form health survey (SF-36)
time frame: Up to 208 weeks
Change From Baseline in Duration of Morning Stiffness
time frame: Up to 208 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.