Abatacept Post-marketing Clinical Study in Japan

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080222075

Enrollment

400

Registered

2013-05-09

Start date

2013-05-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : Abatacept INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: MTX inadequate responder Biologic Naive Functional class I, II or III 6 or more swollen and 6 or more tender joints E19-reactive protein (CRP) 2.0 or more mg/dl or erythrocyte sedimentation rate (ESR) 28 or more mm/hr Anti-cyclic citrullinated peptide (CCP) antibody positive E17Have erosion

Exclusion criteria

Exclusion criteria: Any other rheumatic disease Active angiitis on main organs excluding rheumatoid nodule

Design outcomes

Primary

Measure	Time frame
American College of Rheumatology (ACR) 20% response rate at 4 months (week 16) Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)	—

Secondary

Measure	Time frame
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months Non-progressors rate for the structural damage at 6 months (Week 24) ACR 50 and 70 response rates at 4 months (Week16) Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026