NCT01689532

A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).

Detailed description

This is a randomized (patients will be assigned to treatment by chance), double-blind (study personnel and patients will not know what treatments are being given), multicenter study. The expected duration of the study is 68 weeks. This will include 52 weeks of treatment with study agent with dosing every 2 weeks and 16 weeks of safety follow-up after the last dose. Disease-modifying antirheumatic drugs (DMARDs), including MTX and SSZ, are not permitted from 4 weeks before the first dosing with study agent until Week 24. The use of DMARDs is discouraged at or any time after Week 24; however, patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 24 will be allowed to take DMARDs. At or any time after Week 16, the initiation and/or adjustment of oral corticosteroids will be allowed for patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 16.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Sirukumab 100 mg	Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.
DRUG	Sirukumab 50 mg	Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.
DRUG	Placebo	Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-09-21
• Last updated: 2016-10-27
• Results posted: 2016-10-27

Locations

17 sites across 1 country: Japan