Abatacept Post-marketing Clinical Study in Japan

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Abatacept; Drug: Methotrexate; Drug: Placebo matching with Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01758198

IM101-338

Details and patient eligibility

About

The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.

Enrollment: 405 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MTX inadequate responder
• Biologic Naïve
• Functional class I, II or III
• ≥6 swollen and ≥6 tender joints
• C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
• Anti-cyclic citrullinated peptide (CCP) antibody positive
• Have erosion

Exclusion criteria

• Any other rheumatic disease
• Active angiitis on main organs excluding rheumatoid nodule

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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405 participants in 2 patient groups, including a placebo group

Group 1: Abatacept + Methotrexate (MTX)

Experimental group

Description:

Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months

Treatment:

Drug: Methotrexate

Biological: Abatacept

Group 2: Placebo matching with Abatacept + Methotrexate

Placebo Comparator group

Description:

Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months

Treatment:

Drug: Methotrexate

Drug: Placebo matching with Abatacept