CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,795 enrolled
Drug / intervention
Double-blind Abatacept +2 moredrug
Likely dose
Abatacept 500 mg (body weight <60 kg), 750 mg (body weight 60-100 kg), or 1000 mg (body weight >100 kg) intravenously on Days 1, 15, and 29AI-extracted
Key inclusion· 4
  • ✓Diagnosis of rheumatoid arthritis by American Rheumatism Association criteria
  • ✓American College of Rheumatology functional class I, II, III, or IV
  • ✓On 1 or more DMARDs and/or biologic approved for RA for at least 3 months
  • ✓Stable dose of DMARD/biologic for 28 days prior to Day 1
Key exclusion· 2
  • ✕Other autoimmune disease as main diagnosis (e.g., SLE, Scleroderma)
  • ✕Active tuberculosis requiring treatment within last 3 years

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

Search/NCT00048932
NCT00048932Phase 3Completed
CompareCT.gov

A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

Bristol-Myers Squibb·interventional·Posted Nov 13, 2002·Updated Nov 24, 2011

In Brief

A Phase 3 clinical trial evaluating Double-blind Abatacept, Double-blind Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 1,795 participants across 44 sites.

Detailed Summary

The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 13, 2002
Enrollment StartDec 1, 2002
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 23.6 years ago

Interventions

Double-blind Abataceptdrug

Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Day 1, 15, and 29.

Double-blind Placebodrug

Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.

Open-label Abataceptdrug

Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Every 28 days.