CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 559 enrolled
Drug / intervention
adalimumab 40 mg +3 morebiological
Likely dose
adalimumab 40 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/NCT02019472
NCT02019472Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis

Janssen Research & Development, LLC·interventional·Posted Dec 24, 2013·Updated Oct 26, 2017

In Brief

A Phase 3 clinical trial evaluating adalimumab 40 mg, sirukumab 100 mg, and 2 other interventions for Arthritis, Rheumatoid. Completed, enrolled 559 participants across 107 sites in 16 countries.

Detailed Summary

The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesBulgaria, Chile, Colombia, Germany, Hungary, Lithuania, Mexico, Moldova, Poland, Romania, Russia, Serbia, South Africa, Spain, Ukraine, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 24, 2013
Enrollment StartApr 4, 2014
Primary CompletionAug 17, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.5 years ago

Interventions

adalimumab 40 mgbiological

SC injections

sirukumab 100 mgbiological

SC injections

sirukumab 50 mgbiological

SC injections

Placebodrug

SC injections