CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 431 enrolled
Drug / intervention
Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) +4 moredrug
Likely dose
Abatacept: IV infusion dosed by participant weight, administered monthly; Infliximab: IV infusion dosed by participant weight, administered every 2 monthsAI-extracted
Key inclusion· 3
  • ✓Confirmed diagnosis of rheumatoid arthritis
  • ✓At least 3 months of prior methotrexate treatment
  • ✓Active disease: ≥10 swollen joints, ≥12 tender joints, and CRP ≥1 mg/dL
Key exclusion· 6
  • ✕Prior treatment with any approved biologic drug
  • ✕Failure of more than 3 DMARDs
  • ✕History of cancer within the last 5 years
  • ✕Severe or recurrent bacterial infection

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

Search/NCT00095147
NCT00095147Phase 3Completed
CompareCT.gov

A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate

Bristol-Myers Squibb·interventional·Posted Nov 2, 2004·Updated Mar 24, 2015

In Brief

A Phase 3 clinical trial evaluating Abatacept (ABA) + Methotrexate (MTX), double-blind (DB), Infliximab (INF) + MTX, DB, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 431 participants across 76 sites in 17 countries.

Detailed Summary

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Brazil, Canada, Czechia, Denmark, Mexico, Peru, Poland, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2004
Enrollment StartFeb 1, 2005
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 21.7 years ago

Interventions

Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)drug

Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.

Infliximab (INF) + MTX, DBdrug

Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.

Placebo (PLA) + MTX, DBdrug

Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.

PLA + MTX switched to ABA+ MTX, DBdrug

Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months

ABA, open-label (OL)drug

Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months