Abatacept Post-marketing Clinical Study in Japan

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758198
• Other study ID #: IM101-338
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: May 12, 2017
• Start date: April 11, 2013
• Est. completion date: December 26, 2016

Study information

• Verified date: May 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 26, 2016
• Est. primary completion date: December 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Abatacept

Drug:
• Placebo matching with Abatacept

• Methotrexate

Locations

Country	Name	City	State
Japan	Local Institution	Asahi
Japan	Local Institution	Fuchu
Japan	Local Institution	Fujieda-city	Shizuoka
Japan	Local institution	Fukuoka
Japan	Local Institution	Fukuoka
Japan	Local institution	Funabashi
Japan	Local Institution	Hakodate
Japan	Local Institution	Hiroshima
Japan	Local Institution	Hitachi
Japan	Local institution	Hokkaido
Japan	Local Institution	Iizuka
Japan	Local Institution	Izumisano-city	Osaka
Japan	Local Institution	Kagoshima
Japan	Local Institution	Kagoshima
Japan	Local Institution	Kakogawa-city	Hyogo
Japan	Local Institution	Kamogawa-city	Chiba
Japan	Local Institution	Kanazawa
Japan	Local Institution	Kasama
Japan	Local Institution	Kasamatsu-town	Gifu
Japan	Local Institution	Kato
Japan	Local Institution	Kitakyushu
Japan	Local Institution	Kitakyushu
Japan	Local Institution	Kitakyushu
Japan	Local Institution	Kitamoto
Japan	Local institution	Kobe
Japan	Local institution	Kobe
Japan	Local Institution	Kochi
Japan	Local Institution	Koshi
Japan	Local institution	Kumamoto
Japan	Local Institution	Kurashiki-city	Okayama
Japan	Local Institution	Matsumoto
Japan	Local Institution	Nagano
Japan	Local Institution	Nagaoka
Japan	Local Institution	Nagasaki
Japan	Local Institution	Nagoya
Japan	Local Institution	Nagoya
Japan	Local Institution	Narashino
Japan	Local Institution	Narita
Japan	Local Institution	Okayama
Japan	Local institution	Osaka
Japan	Local Institution	Osaki
Japan	Local institution	Oume
Japan	Local institution	Sapporo
Japan	Local Institution	Sapporo
Japan	Local Institution	Sapporo
Japan	Local Institution	Sapporo
Japan	Local Institution	Sasebo
Japan	Local Institution	Sayama
Japan	Local Institution	Sendai
Japan	Local Institution	Sendai
Japan	Local Institution	Sendai
Japan	Local Institution	Shimonoseki-city	Yamaguchi
Japan	Local Institution	Shizuoka
Japan	Local Institution	Takaoka
Japan	Local Institution	Takasaki
Japan	Local institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tokyo
Japan	Local Institution	Tomakomai
Japan	Local Institution	Toyama
Japan	Local Institution	Toyama
Japan	Local Institution	Toyama-city	Toyama
Japan	Local Institution	Utsunomiya
Japan	Local institution	Yokohama
Japan	Local institution	Yokohama
Japan	Local Institution	Yokohama-city	Kanagawa
Japan	Local Institution	Yotsukaido

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR) 20% response rate		4 months (week 16)
Primary	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	Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)		Baseline (Day 1), 4 months (Week 16)
Secondary	Non-progressors rate for the structural damage	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)	Baseline (Day 1), 6 months (Week 24)
Secondary	ACR 50 response rates		4 months (Week16)
Secondary	ACR 70 response rates		4 months (Week16)
Secondary	Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities		12 months (Week52)

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls