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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Abatacept; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00124449

IM101-046

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.
• 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

Trial design

56 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Abatacept

2

Placebo Comparator group

Treatment:

Drug: placebo