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Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

NCT00124449 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-04-07

Study results available
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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).

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Abatacept

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

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-05-31
Completion
2008-04-30

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Italy
  • Mexico
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00124449 on ClinicalTrials.gov