CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 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/NCT01689532
NCT01689532Phase 3Completed
CompareCT.gov

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

Janssen Pharmaceutical K.K.·interventional·Posted Sep 21, 2012·Updated Oct 27, 2016

In Brief

A Phase 3 clinical trial evaluating Sirukumab 100 mg, Sirukumab 50 mg, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 122 participants across 17 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesJapan
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartNov 1, 2012
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.8 years ago

Interventions

Sirukumab 100 mgdrug

Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.

Sirukumab 50 mgdrug

Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.

Placebodrug

Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.