NCT00292422

Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis

A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF therapy. This study will assist with dose selection for further planned Phase 2 studies.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	BG9924

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-02-16
• Last updated: 2007-12-31

Locations

10 sites across 2 countries: United States, Poland