A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

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

NCT00409838

IM101-124

Details and patient eligibility

About

The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
• Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
• Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses

Key Exclusion Criteria:

• Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 3 patient groups, including a placebo group

Abatacept and Methotrexate

Experimental group

Treatment:

Drug: Abatacept

Drug: Methotrexate

Drug: Methotrexate

Drug: Abatacept

Placebo and Methotrexate

Placebo Comparator group

Description:

(standard of care)

Treatment:

Drug: Placebo

Drug: Methotrexate

Drug: Methotrexate

Abatacept - Open Label

Experimental group

Description:

Open-label extension phase

Treatment:

Drug: Abatacept

Drug: Methotrexate

Drug: Methotrexate

Drug: Abatacept