CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Abatacept +1 moredrug
Likely dose
Abatacept weight-based IV monthly: <60 kg = 500 mg; 60–100 kg = 750 mg; >100 kg = 1 gAI-extracted
Key inclusion· 6
  • ✓Diagnosis of undifferentiated arthritis
  • ✓Clinical synovitis of two or more joints
  • ✓At least one but not more than three criteria for RA diagnosis (1987)
  • ✓Positive for anti-CCP antibodies
Key exclusion· 5
  • ✕Women of childbearing potential unwilling or unable to use acceptable contraception
  • ✕Active vasculitis of a major organ system
  • ✕Severe or recurrent bacterial infection
  • ✕History of cancer in the last 5 years (except certain skin cancers)

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

Search/NCT00124449
NCT00124449Phase 2Completed
CompareCT.gov

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Bristol-Myers Squibb·interventional·Posted Jul 28, 2005·Updated Apr 7, 2015

In Brief

A Phase 2 clinical trial evaluating Abatacept and placebo for Arthritis, Rheumatoid. Completed, enrolled 56 participants across 48 sites in 10 countries.

Detailed Summary

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesAustralia, Belgium, France, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2005
Enrollment StartFeb 1, 2005
Primary CompletionMay 1, 2007
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.9 years ago

Interventions

Abataceptdrug

solution, intravenous injection, monthly, 169 days weight based: \<60 kg = 500 mg 60 to 100 kg = 750 mg \>100 kg = 1 g

placebodrug

solution, intravenous injection, 0 mg, monthly, 169 days