CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 524 enrolled
Drug / intervention
Abatacept (BMS-188667) +3 moredrug
Likely dose
Abatacept (BMS-188667) 2 mg/kg or 10 mg/kg intravenously on Days 1, 15, 30 and monthly thereafter for 12 monthsAI-extracted
Key inclusion· 5
  • ✓Males or females age ≥18 years; women of childbearing potential must use effective contraception and not be pregnant or nursing
  • ✓Diagnosis of rheumatoid arthritis per American Rheumatism Association (1987) criteria, functional class I, II, or III per American College of Rheumatology (1991)
  • ✓Currently taking methotrexate 10–30 mg weekly for ≥6 months at stable dose for ≥28 days
  • ✓For methotrexate monotherapy: ≥10 swollen joints, ≥12 tender joints, and CRP ≥0.1 mg/dL at screening
Key exclusion· 12
  • ✕Prior treatment with BMS-188667 (abatacept)
  • ✕Investigational drug within 30 days of Day 1 visit
  • ✕Active vasculitis of a major organ system (excluding subcutaneous rheumatoid nodules)
  • ✕Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or concomitant medical conditions placing subject at unacceptable risk

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

Search/NCT00162266
NCT00162266Phase 2Completed
CompareCT.gov

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Bristol-Myers Squibb·interventional·Posted Sep 13, 2005·Updated Jun 1, 2012

In Brief

A Phase 2 clinical trial evaluating Abatacept (BMS-188667) and Placebo for Rheumatoid Arthritis. Completed, enrolled 524 participants across 57 sites in 11 countries.

Detailed Summary

This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, Canada, France, Germany, Ireland, Netherlands, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2005
Enrollment StartOct 1, 2000
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.8 years ago

Interventions

Abatacept (BMS-188667)drug

IV, 10 mg/Kg, monthly, for the duration of the trial

Abatacept (BMS-188667)drug

Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

Abatacept (BMS-188667)drug

Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

Placebodrug

Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months