Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept; Drug: methotrexate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00122382

IM101-023

Details and patient eligibility

About

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Enrollment: 1,052 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.
• C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)
• Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
• Tender joints >=12 and swollen joints >=10

Exclusion criteria

• Women and men who are not willing to use birth control
• Diagnosed with other rheumatic disease
• History of cancer within 5 years
• Active tuberculosis
• Treatment with another investigation drug within 28 days
• Active bacterial or viral infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,052 participants in 2 patient groups

ABA + MTX

Active Comparator group

Description:

abatacept 10 mg/kg intravenous (IV) + methotrexate

Treatment:

Drug: methotrexate

Drug: Abatacept

Placebo (PLA) + MTX

Active Comparator group

Description:

placebo IV + methotrexate

Treatment:

Drug: methotrexate

Drug: placebo

Drug: Abatacept