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

April 11, 2011 updated by: Bristol-Myers Squibb

A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba-Shi, Japan, 260-0801
        • Local Institution
      • Tochigi, Japan, 329-0498
        • Local Institution
    • Aichi
      • Nagoya, Aichi, Japan, 466-8550
        • Local Institution
      • Nagoya-Shi, Aichi, Japan, 460-0001
        • Local Institution
    • Aomori
      • Goshogawara-Shi, Aomori, Japan, 037-0053
        • Local Institution
    • Chiba
      • Chiba-Shi, Chiba, Japan
        • Local Institution
    • Fukui
      • Fukui-Shi, Fukui, Japan, 910-0041
        • Local Institution
      • Fukui-Shi, Fukui, Japan, 910-0067
        • Local Institution
    • Fukuoka
      • Fukuoka-Shi, Fukuoka, Japan, 810-0065
        • Local Institution
      • Fukuoka-Shi, Fukuoka, Japan, 812-0025
        • Local Institution
      • Kitakyushu-Shi, Fukuoka, Japan, 807-8555
        • Local Institution
    • Hiroshima
      • Higashi-Hiroshima-Shi, Hiroshima, Japan, 739-0002
        • Local Institution
    • Hokkaido
      • Sapporo City, Hokkaido, Japan, 060-8648
        • Local Institution
      • Sapporo-City, Hokkaido, Japan, 060-0001
        • Local Institution
      • Sapporo-City, Hokkaido, Japan, 060-8604
        • Local Institution
    • Hyogo
      • Kanzaki-Gun, Hyogo, Japan, 679-2414
        • Local Institution
      • Kato-Gun, Hyogo, Japan, 673-1462
        • Local Institution
    • Ibaraki
      • Hitachi-Shi, Ibaraki, Japan, 316-0035
        • Local Institution
      • Tsukuba-Shi, Ibaraki, Japan, 305-0005
        • Local Institution
    • Kanagawa
      • Sagamihara-Shi, Kanagawa, Japan, 228-8522
        • Local Institution
    • Miyagi
      • Sendai, Miyagi, Japan
        • Local Institution
      • Sendai-Shi, Miyagi, Japan, 981-0911
        • Local Institution
      • Sendai-Shi, Miyagi, Japan, 982-0032
        • Local Institution
    • Nagano
      • Nagano-Shi, Nagano, Japan, 380-8582
        • Local Institution
    • Okayama
      • Tsukubo-Gun, Okayama, Japan, 701-0304
        • Local Institution
    • Osaka
      • Kawachinagano-Shi, Osaka, Japan, 86-0008
        • Local Institution
    • Saga
      • Ureshino-Shi, Saga, Japan, 843-0301
        • Local Institution
    • Saitama
      • Iruma-Gun, Saitama, Japan, 350-0495
        • Local Institution
      • Kawagoe-Shi, Saitama, Japan, 350-8550
        • Local Institution
      • Kitamoto-Shi, Saitama, Japan, 364-0026
        • Local Institution
    • Shizuoka
      • Hamamatsu-Shi, Shizuoka, Japan, 430-0906
        • Local Institution
    • Tochigi
      • Kawachigun, Tochigi, Japan, 329-1104
        • Local Institution
    • Tokyo
      • Arakawa-Ku, Tokyo, Japan, 116-0011
        • Local Institution
      • Bunkyo-Ku, Tokyo, Japan, 113-0022
        • Local Institution
      • Bunkyo-Ku, Tokyo, Japan, 113-8519
        • Local Institution
      • Setagaya-Ku, Tokyo, Japan, 155-0032
        • Local Institution
      • Shinjuku-Ku, Tokyo, Japan, 162-0054
        • Local Institution
    • Toyama
      • Takaoka-Shi, Toyama, Japan, 933-8525
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Active Comparator: Abatacept 2 mg/kg
Drug: Abatacept
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Other Names:
  • Orencia
Active Comparator: Abatacept 10 mg/kg
Drug: Abatacept
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline.
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity
Time Frame: at 6 months
at 6 months
Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

June 23, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

April 25, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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