NCT00810836

Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

Detailed description

The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	BG00012	oral
DRUG	BG00012	Oral
DRUG	placebo	oral placebo

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2008-12-18
• Last updated: 2013-09-16

Locations

24 sites across 6 countries: Australia, Canada, Czechia, India, Poland, Slovakia