NCT01604343

A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite DMARD Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,670 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) and inhibition of radiographic progression in patients with active RA who are unresponsive to treatment with disease-modifying antirheumatic drugs (DMARD).

Detailed description

Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 120 weeks, which includes 104 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long-term safety and efficacy study, if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 52, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Placebo	Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 50.
DRUG	Placebo	Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 104.
DRUG	Sirukumab	Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 52 through Week 104.
DRUG	Sirukumab	Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 104.
DRUG	Sirukumab	Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 104.

Timeline

• Start date: 2012-08-15
• Primary completion: 2015-09-02
• Completion: 2016-12-06
• First posted: 2012-05-23
• Last updated: 2018-01-11
• Results posted: 2018-01-11

Locations

156 sites across 18 countries: United States, Bulgaria, Canada, Chile, Colombia, Croatia, Japan, Lithuania, Malaysia, Mexico, Poland, Romania, Russia, Serbia, South Africa, South Korea, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study