Clinical trial NCT01758198: Abatacept Post-marketing Clinical Study in Japan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2013-01-01
Enrollment: 405
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: American College of Rheumatology (ACR) 20% response rate
timeFrame: 4 months (week 16)
measure: Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
timeFrame: Baseline (Day 1), 6 months (Week 24)
Secondary outcomes:
measure: Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)
timeFrame: Baseline (Day 1), 4 months (Week 16)
measure: Non-progressors rate for the structural damage
timeFrame: Baseline (Day 1), 6 months (Week 24)
measure: ACR 50 response rates
timeFrame: 4 months (Week16)
measure: ACR 70 response rates
timeFrame: 4 months (Week16)
measure: Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities
timeFrame: 12 months (Week52)
Other outcomes:
Locations:
city: Kamogawa-city
country: Japan
facility: Local Institution
state: Chiba
city: Kasamatsu-town
country: Japan
facility: Local Institution
state: Gifu
city: Kakogawa-city
country: Japan
facility: Local Institution
state: Hyogo
city: Yokohama-city
country: Japan
facility: Local Institution
state: Kanagawa
city: Kurashiki-city
country: Japan
facility: Local Institution
state: Okayama
city: Izumisano-city
country: Japan
facility: Local Institution
state: Osaka
city: Fujieda-city
country: Japan
facility: Local Institution
state: Shizuoka
city: Toyama-city
country: Japan
facility: Local Institution
state: Toyama
city: Shimonoseki-city
country: Japan
facility: Local Institution
state: Yamaguchi
city: Asahi
country: Japan
facility: Local Institution
city: Fuchu
country: Japan
facility: Local Institution
city: Fukuoka
country: Japan
facility: Local institution
city: Fukuoka
country: Japan
facility: Local Institution
city: Funabashi
country: Japan
facility: Local institution
city: Hakodate
country: Japan
facility: Local Institution
city: Hiroshima
country: Japan
facility: Local Institution
city: Hitachi
country: Japan
facility: Local Institution
city: Hokkaido
country: Japan
facility: Local institution
city: Iizuka
country: Japan
facility: Local Institution
city: Kagoshima
country: Japan
facility: Local Institution
city: Kagoshima
country: Japan
facility: Local Institution
city: Kanazawa
country: Japan
facility: Local Institution
city: Kasama
country: Japan
facility: Local Institution
city: Kato
country: Japan
facility: Local Institution
city: Kitakyushu
country: Japan
facility: Local Institution
city: Kitakyushu
country: Japan
facility: Local Institution
city: Kitakyushu
country: Japan
facility: Local Institution
city: Kitamoto
country: Japan
facility: Local Institution
city: Kobe
country: Japan
facility: Local institution
city: Kobe
country: Japan
facility: Local institution
city: Kochi
country: Japan
facility: Local Institution
city: Koshi
country: Japan
facility: Local Institution
city: Kumamoto
country: Japan
facility: Local institution
city: Matsumoto
country: Japan
facility: Local Institution
city: Nagano
country: Japan
facility: Local Institution
city: Nagaoka
country: Japan
facility: Local Institution
city: Nagasaki
country: Japan
facility: Local Institution
city: Nagoya
country: Japan
facility: Local Institution
city: Nagoya
country: Japan
facility: Local Institution
city: Narashino
country: Japan
facility: Local Institution
city: Narita
country: Japan
facility: Local Institution
city: Okayama
country: Japan
facility: Local Institution
city: Osaka
country: Japan
facility: Local institution
city: Osaki
country: Japan
facility: Local Institution
city: Oume
country: Japan
facility: Local institution
city: Sapporo
country: Japan
facility: Local institution
city: Sapporo
country: Japan
facility: Local Institution
city: Sapporo
country: Japan
facility: Local Institution
city: Sapporo
country: Japan
facility: Local Institution
city: Sasebo
country: Japan
facility: Local Institution
city: Sayama
country: Japan
facility: Local Institution
city: Sendai
country: Japan
facility: Local Institution
city: Sendai
country: Japan
facility: Local Institution
city: Sendai
country: Japan
facility: Local Institution
city: Shizuoka
country: Japan
facility: Local Institution
city: Takaoka
country: Japan
facility: Local Institution
city: Takasaki
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
city: Tomakomai
country: Japan
facility: Local Institution
city: Toyama
country: Japan
facility: Local Institution
city: Toyama
country: Japan
facility: Local Institution
city: Utsunomiya
country: Japan
facility: Local Institution
city: Yokohama
country: Japan
facility: Local institution
city: Yokohama
country: Japan
facility: Local institution
city: Yotsukaido
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: