CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,286 enrolled
Drug / intervention
Abatacept +2 moredrug
Likely dose
Abatacept 500 mg to 1 gram IV monthly based on body weightAI-extracted
Key inclusion· 4
  • ✓Completed the double-blind portion of the IM101064 study
  • ✓Rheumatoid arthritis diagnosed >1 year ago
  • ✓ACR functional class I, II, or III
  • ✓Current or prior anti-TNF therapy at approved labeled dose for ≥3 months
Key exclusion· 2
  • ✕Active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
  • ✕History of cancer within the last 5 years (except non-melanoma skin cancers cured by local resection)

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

Search/NCT00124982
NCT00124982Phase 3Completed
CompareCT.gov

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Bristol-Myers Squibb·interventional·Posted Jul 29, 2005·Updated Feb 27, 2012

In Brief

A Phase 3 clinical trial evaluating Abatacept, Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD), and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 1,286 participants across 148 sites in 10 countries.

Detailed Summary

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Czechia, France, Germany, Ireland, Italy, Mexico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2005
Enrollment StartApr 1, 2005
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.9 years ago

Interventions

Abataceptdrug

IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)drug

During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

Anti-Tumor Necrosing Factor (TNF) Therapydrug

Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months