NCT02019472

A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 559 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, parallel-group, global, multicenter study of subcutaneous (SC) sirukumab monotherapy compared with adalimumab monotherapy in subjects with active rheumatoid arthritis. Approximately 510 subjects will be randomly assigned in a 1:1:1 ratio to receive treatment with adalimumab 40 mg SC every 2 weeks, sirukumab 100 mg SC every 2 weeks, or 50 mg SC every 4 weeks, with approximately 170 subjects per treatment group. At Week 16, subjects in all treatment groups who have \< 20% improvement from baseline in both swollen and tender joint counts will qualify for early escape. The expected duration of the study is 68 weeks. This includes 52 weeks of treatment with study agent and 16 weeks of safety follow-up after the last study agent administration. The study will end when the last subject completes the last scheduled visit (Week 68 visit or completes the 16 week safety follow-up, whichever is later). Subject safety will be monitored through the end of the study.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab 40 mg	SC injections
BIOLOGICAL	sirukumab 100 mg	SC injections
BIOLOGICAL	sirukumab 50 mg	SC injections
DRUG	Placebo	SC injections

Timeline

• Start date: 2014-04-04
• Primary completion: 2016-08-17
• Completion: 2016-08-17
• First posted: 2013-12-24
• Last updated: 2017-10-26
• Results posted: 2017-09-14

Locations

107 sites across 16 countries: United States, Bulgaria, Chile, Colombia, Germany, Hungary, Lithuania, Mexico, Moldova, Poland, Romania, Russia, Serbia, South Africa, Spain, Ukraine