Abatacept Post-marketing Clinical Study in Japan

• Status: Completed
• Trial end date: 2016-12-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Abatacept; Methotrexate

Criteria

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