A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

NCT ID: NCT00345748

Last Updated: 2011-04-25

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

PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-11-30

Brief Summary

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The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.

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

DOUBLE

Participants Investigators

Study Groups

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Abatacept 2 mg/kg

Group Type ACTIVE_COMPARATOR

Abatacept

Intervention Type DRUG

Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Abatacept 10 mg/kg

Group Type ACTIVE_COMPARATOR

Abatacept

Intervention Type DRUG

Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Interventions

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Abatacept

Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Intervention Type DRUG

Placebo

Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Orencia

Eligibility Criteria

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Inclusion Criteria

* patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization

Exclusion Criteria

* no current infection or other evolutive or uncontrolled disease
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Goshogawara-Shi, Aomori, Japan

Site Status

Local Institution

Chiba, Chiba, Japan

Site Status

Local Institution

Fukui-shi, Fukui, Japan

Site Status

Local Institution

Fukui-shi, Fukui, Japan

Site Status

Local Institution

Fukuoka, Fukuoka, Japan

Site Status

Local Institution

Fukuoka, Fukuoka, Japan

Site Status

Local Institution

Kitakyushu-Shi, Fukuoka, Japan

Site Status

Local Institution

Higashi-Hiroshima-Shi, Hiroshima, Japan

Site Status

Local Institution

Sapporo, Hokkaido, Japan

Site Status

Local Institution

Sapporo, Hokkaido, Japan

Site Status

Local Institution

Sapporo, Hokkaido, Japan

Site Status

Local Institution

Kanzaki-Gun, Hyōgo, Japan

Site Status

Local Institution

Kato-Gun, Hyōgo, Japan

Site Status

Local Institution

Hitachi-Shi, Ibaraki, Japan

Site Status

Local Institution

Tsukuba, Ibaraki, Japan

Site Status

Local Institution

Sagamihara-Shi, Kanagawa, Japan

Site Status

Local Institution

Sendai, Miyagi, Japan

Site Status

Local Institution

Sendai, Miyagi, Japan

Site Status

Local Institution

Sendai, Miyagi, Japan

Site Status

Local Institution

Nagano, Nagano, Japan

Site Status

Local Institution

Tsukubo-Gun, Okayama-ken, Japan

Site Status

Local Institution

Kawachinagano-Shi, Osaka, Japan

Site Status

Local Institution

Ureshino-Shi, Saga-ken, Japan

Site Status

Local Institution

Iruma-Gun, Saitama, Japan

Site Status

Local Institution

Kawagoe-Shi, Saitama, Japan

Site Status

Local Institution

Kitamoto-Shi, Saitama, Japan

Site Status

Local Institution

Hamamatsu, Shizuoka, Japan

Site Status

Local Institution

Kawachigun, Tochigi, Japan

Site Status

Local Institution

Tochigi, Tochigi, Japan

Site Status

Local Institution

Arakawa-Ku, Tokyo, Japan

Site Status

Local Institution

Bunkyo-Ku, Tokyo, Japan

Site Status

Local Institution

Bunkyo-Ku, Tokyo, Japan

Site Status

Local Institution

Setagaya-Ku, Tokyo, Japan

Site Status

Local Institution

Shinjuku-Ku, Tokyo, Japan

Site Status

Local Institution

Takaoka-Shi, Toyama, Japan

Site Status

Local Institution

Chiba, , Japan

Site Status

Countries

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Japan

Other Identifiers

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IM101-071

Identifier Type: -

Identifier Source: org_study_id

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