Abatacept Post-marketing Clinical Study in Japan

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Abatacept; Drug: Placebo matching with Abatacept; Drug: Methotrexate

• Registration Number: NCT01758198
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-26
• Study First Posted: 2013-01-01
• Study Start: 2013-04-11
• Primary Completion: 2016-12-26
• Study Completion: 2016-12-26
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Abatacept + Methotrexate (MTX)	Abatacept	Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Group 1: Abatacept + Methotrexate (MTX)	Methotrexate	Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Group 2: Placebo matching with Abatacept + Methotrexate	Placebo matching with Abatacept	Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Group 2: Placebo matching with Abatacept + Methotrexate	Methotrexate	Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)	Baseline (Day 1), 4 months (Week 16)
Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities	12 months (Week52)
ACR 70 response rates	4 months (Week16)
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)

Trial Locations

Locations (2)

Local Institution; 🇯🇵 Yotsukaido, Japan

Local institution; 🇯🇵 Yokohama, Japan