Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Diagnosis of RA.

• All subjects will be required to have been taking a stable dose of methotrexate.

• Active RA at screening defined as greater than or equal to 6 swollen joints.

• The presence of erosive disease

Exclusion Criteria:

• Received any biologic agent (e.g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava® within 8 weeks before randomization; past use of these agents is allowed.

• Steroid use greater than 15 mg/day.

• Scheduled for surgery or joint replacement in the hands, wrists or feet.