NCT01597739

A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) therapy.

Detailed description

This is a randomized (treatment assigned by chance, like flipping a coin), multicenter, double-blind (neither physician nor patient will know the treatment the patient receives), parallel-group (each group of patients will be treated at the same time) study. JNJ-40346527 will be compared to a placebo, which is an inactive substance used to test whether a drug has a real effect. Patients will receive study medication for 12 weeks and will continue their permitted, stable DMARD therapy (methotrexate \[MTX\], sulfasalazine \[SSZ\], and/or hydroxychloroquine \[HCQ\]) through Week 12. A follow-up visit will occur 4 weeks after dosing is complete. The maximum length of patient participation will be 22 weeks, including a 6-week screening period. Other study visits will occur during the study, and patient safety will be monitored.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	JNJ-40346527	Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
DRUG	Placebo	Form=capsule; route=oral use; twice daily.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-05-14
• Last updated: 2014-04-08

Locations

32 sites across 10 countries: Argentina, Bulgaria, Chile, Czechia, Hungary, Poland, Russia, Singapore, South Korea, Ukraine