NCT00941707

An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy.

Detailed description

This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) and parallel-group (each group of participants will be treated at the same time) study. The study will consist of 3 phases; Screening phase (3 weeks), Treatment phase (12 weeks) and Follow-up phase (4 weeks). Each participant will be enrolled in the study for approximately 19 weeks. Participants with active rheumatoid arthritis despite MTX therapy will receive JNJ-38518168, 100 milligram (mg) per day or matching placebo capsules once daily for 12 weeks. Efficacy will be primarily evaluated by change from Baseline in disease activity index score C-reactive protein at Week 12. Participants' safety will be monitored throughout the study.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	JNJ 38518168	JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks.
DRUG	Placebo	Placebo capsules matching to JNJ-38518168 orally once daily for 12 weeks.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-07-20
• Last updated: 2013-04-23

Locations

34 sites across 10 countries: Belgium, Czechia, Ireland, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom