Status:

COMPLETED

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

Lead Sponsor:

Amgen

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 11 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2007

Estimated Enrollment :

227 Patients enrolled

Trial Details

Trial ID

NCT00095498

Start Date

August 11 2004

End Date

April 1 2007

Last Update

October 25 2021

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