A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and 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

NCT00048568

IM101-102

Details and patient eligibility

About

Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.

Enrollment: 1,250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.
• Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,250 participants in 3 patient groups

Abatacept + Methotrexate

Experimental group

Description:

Short Term: Abatacept was dosed by weight with participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a minimum dose of 15 mg.

Treatment:

Drug: Abatacept

Drug: Methotrexate

Placebo + Methotrexate

Active Comparator group

Description:

Short Term: Participants received a placebo solution intravenously and methotrexate at the dose employed prior to study enrollment and a minimum of 15 mg.

Treatment:

Drug: Placebo

Drug: Methotrexate

Abatacept + Methotrexate Open Label

Experimental group

Description:

Open Label: Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.

Treatment:

Drug: Abatacept

Drug: Methotrexate