Back to resultsA Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Abatacept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Local Institution
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- Local Institution
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- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Abatacept 2 mg/kg
Abatacept 10 mg/kg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00345748
Brief Title
A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abatacept 2 mg/kg
Arm Type
Active Comparator
Arm Title
Abatacept 10 mg/kg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Description
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Nagoya-Shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Local Institution
City
Goshogawara-Shi
State/Province
Aomori
ZIP/Postal Code
037-0053
Country
Japan
Facility Name
Local Institution
City
Chiba-Shi
State/Province
Chiba
Country
Japan
Facility Name
Local Institution
City
Fukui-Shi
State/Province
Fukui
ZIP/Postal Code
910-0041
Country
Japan
Facility Name
Local Institution
City
Fukui-Shi
State/Province
Fukui
ZIP/Postal Code
910-0067
Country
Japan
Facility Name
Local Institution
City
Fukuoka-Shi
State/Province
Fukuoka
ZIP/Postal Code
810-0065
Country
Japan
Facility Name
Local Institution
City
Fukuoka-Shi
State/Province
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Local Institution
City
Kitakyushu-Shi
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Local Institution
City
Higashi-Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
739-0002
Country
Japan
Facility Name
Local Institution
City
Sapporo City
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Local Institution
City
Sapporo-City
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Local Institution
City
Sapporo-City
State/Province
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Local Institution
City
Kanzaki-Gun
State/Province
Hyogo
ZIP/Postal Code
679-2414
Country
Japan
Facility Name
Local Institution
City
Kato-Gun
State/Province
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Local Institution
City
Hitachi-Shi
State/Province
Ibaraki
ZIP/Postal Code
316-0035
Country
Japan
Facility Name
Local Institution
City
Tsukuba-Shi
State/Province
Ibaraki
ZIP/Postal Code
305-0005
Country
Japan
Facility Name
Local Institution
City
Sagamihara-Shi
State/Province
Kanagawa
ZIP/Postal Code
228-8522
Country
Japan
Facility Name
Local Institution
City
Sendai-Shi
State/Province
Miyagi
ZIP/Postal Code
981-0911
Country
Japan
Facility Name
Local Institution
City
Sendai-Shi
State/Province
Miyagi
ZIP/Postal Code
982-0032
Country
Japan
Facility Name
Local Institution
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Local Institution
City
Nagano-Shi
State/Province
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Facility Name
Local Institution
City
Tsukubo-Gun
State/Province
Okayama
ZIP/Postal Code
701-0304
Country
Japan
Facility Name
Local Institution
City
Kawachinagano-Shi
State/Province
Osaka
ZIP/Postal Code
86-0008
Country
Japan
Facility Name
Local Institution
City
Ureshino-Shi
State/Province
Saga
ZIP/Postal Code
843-0301
Country
Japan
Facility Name
Local Institution
City
Iruma-Gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Local Institution
City
Kawagoe-Shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Local Institution
City
Kitamoto-Shi
State/Province
Saitama
ZIP/Postal Code
364-0026
Country
Japan
Facility Name
Local Institution
City
Hamamatsu-Shi
State/Province
Shizuoka
ZIP/Postal Code
430-0906
Country
Japan
Facility Name
Local Institution
City
Kawachigun
State/Province
Tochigi
ZIP/Postal Code
329-1104
Country
Japan
Facility Name
Local Institution
City
Arakawa-Ku
State/Province
Tokyo
ZIP/Postal Code
116-0011
Country
Japan
Facility Name
Local Institution
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-0022
Country
Japan
Facility Name
Local Institution
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Local Institution
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
155-0032
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-0054
Country
Japan
Facility Name
Local Institution
City
Takaoka-Shi
State/Province
Toyama
ZIP/Postal Code
933-8525
Country
Japan
Facility Name
Local Institution
City
Chiba-Shi
ZIP/Postal Code
260-0801
Country
Japan
Facility Name
Local Institution
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
12. IPD Sharing Statement
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A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
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