CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 227 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Confirmed diagnosis of rheumatoid arthritis
  • ✓Stable dose of methotrexate required
  • ✓Active RA at screening with ≥6 swollen joints
  • ✓Presence of erosive disease
Key exclusion· 3
  • ✕Biologic agents (Enbrel, Remicade, Humira, Kineret) or Arava within 8 weeks prior to randomization
  • ✕Corticosteroid dose exceeding 15 mg/day
  • ✕Planned surgery or joint replacement in hands, wrists, or feet

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00095498
NCT00095498Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Amgen·interventional·Posted Nov 8, 2004·Updated Oct 25, 2021

In Brief

A Phase 2 clinical trial evaluating placebo and denosumab for Rheumatoid Arthritis. Completed, enrolled 227 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2004
Enrollment StartAug 11, 2004
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 21.7 years ago

Interventions

placebodrug

placebo subcutaneous injection

denosumabdrug

For subcutaneous injection