A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345748

IM101-071

Details and patient eligibility

About

The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.

Enrollment: 194 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization

Exclusion criteria

• no current infection or other evolutive or uncontrolled disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 3 patient groups, including a placebo group

Abatacept 2 mg/kg

Active Comparator group

Treatment:

Drug: Abatacept

Abatacept 10 mg/kg

Active Comparator group

Treatment:

Drug: Abatacept

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo