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

Phase 2

Active, not recruiting

• Conditions: ndifferentiated Arthritis (UA); Undifferentiated Arthritis (UA); Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12605000785606
• Lead Sponsor: Bristol-Myers Squibb Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Diagnosis of undifferentiated arthritis Clinical synovitis of two or more joints At least one but not more than three of the criteria for diagnosis of RA (1987). No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics. Duration of disease must be 18 months or less. Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria

Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy. Men unwilling to use an adequate method of contraception. Active vasculitis of a major organ system. Severe or recurrent bacterial infection. History of cancer in the last five years except certain skin cancers. Herpes zoster that resolved less than 2 months prior to enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects wih a diagnosis of Rheumatoid Arthritis by ARA criteria[At 12 months]

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a diagnosis of RA by 1987 ARA criteria.[At 24 months.];The proportion of subjects with persistent symptomatic clinical synovitis.[At 6, 12, and 24 months.];The mean DAS 28 (crp) score.[At 6, 12, and 24 months.]