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

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758198

Enrollment

405

Registered

2013-01-01

Start date

2013-04-11

Completion date

2016-12-26

Last updated

2017-05-15

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

Conditions

Rheumatoid Arthritis

Brief 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.

Interventions

BIOLOGICALAbatacept

DRUGPlacebo matching with Abatacept

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
American College of Rheumatology (ACR) 20% response rate	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)	Baseline (Day 1), 6 months (Week 24)

Secondary

Measure	Time frame	Description
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)	Baseline (Day 1), 4 months (Week 16)	—
Non-progressors rate for the structural damage	Baseline (Day 1), 6 months (Week 24)	The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)
ACR 50 response rates	4 months (Week16)	—
ACR 70 response rates	4 months (Week16)	—
Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities	12 months (Week52)	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026