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Abatacept Post-marketing Clinical Study in Japan

NCT ID: NCT01758198

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-11

Study Completion Date

2016-12-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1: Abatacept + Methotrexate (MTX)

Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months

Methotrexate ≥6 mg/week for 12 months

Group Type EXPERIMENTAL

Abatacept

Intervention Type BIOLOGICAL

Methotrexate

Intervention Type DRUG

Group 2: Placebo matching with Abatacept + Methotrexate

Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months

Methotrexate ≥6 mg/week for 12 months

Group Type PLACEBO_COMPARATOR

Placebo matching with Abatacept

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Interventions

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Abatacept

Intervention Type BIOLOGICAL

Placebo matching with Abatacept

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Other Intervention Names

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BMS-188667 (Orencia)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Kamogawa, Chiba, Japan

Site Status

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Kasamatsu-town, Gifu, Japan

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Kakogawa, Hyōgo, Japan

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Yokohama, Kanagawa, Japan

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Kurashiki, Okayama-ken, Japan

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Izumisano, Osaka, Japan

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Fujieda, Shizuoka, Japan

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Toyama, Toyama, Japan

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Shimonoseki, Yamaguchi, Japan

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Asahi, , Japan

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Fuchū, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Funabashi, , Japan

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Hakodate, , Japan

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Hiroshima, , Japan

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Hitachi, , Japan

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Hokkaido, , Japan

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Iizuka, , Japan

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Kagoshima, , Japan

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Kagoshima, , Japan

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Kanazawa, , Japan

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Kasama, , Japan

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Katō, , Japan

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Kitakyushu, , Japan

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Kitakyushu, , Japan

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Kitakyushu, , Japan

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Kitamoto, , Japan

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Kobe, , Japan

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Kobe, , Japan

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Kochi, , Japan

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Kōshi, , Japan

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Kumamoto, , Japan

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Matsumoto, , Japan

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Nagano, , Japan

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Nagaoka, , Japan

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Nagasaki, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Narashino, , Japan

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Narita, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Ōme, , Japan

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Ōsaki, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sasebo, , Japan

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Sayama, , Japan

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Sendai, , Japan

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Sendai, , Japan

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Sendai, , Japan

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Shizuoka, , Japan

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Takaoka, , Japan

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Takasaki, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tomakomai, , Japan

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Toyama, , Japan

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Toyama, , Japan

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Utsunomiya, , Japan

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Yokohama, , Japan

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Yokohama, , Japan

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Yotsukaidō, , Japan

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Countries

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Japan

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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IM101-338

Identifier Type: -

Identifier Source: org_study_id

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