A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00345748
First received: June 23, 2006
Last updated: April 11, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Abatacept Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
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. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 194 |
| Study Start Date: | June 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Abatacept 2 mg/kg |
Drug: Abatacept
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Other Name: Orencia
|
| Active Comparator: Abatacept 10 mg/kg |
Drug: Abatacept
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
Other Name: Orencia
|
| Placebo Comparator: Placebo |
Drug: Placebo
Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345748
Locations
| Japan | |
| Local Institution | |
| Nagoya, Aichi, Japan, 466-8550 | |
| Local Institution | |
| Nagoya-Shi, Aichi, Japan, 460-0001 | |
| Local Institution | |
| Goshogawara-Shi, Aomori, Japan, 037-0053 | |
| Local Institution | |
| Chiba-Shi, Chiba, Japan | |
| Local Institution | |
| Fukui-Shi, Fukui, Japan, 910-0067 | |
| Local Institution | |
| Fukui-Shi, Fukui, Japan, 910-0041 | |
| Local Institution | |
| Fukuoka-Shi, Fukuoka, Japan, 812-0025 | |
| Local Institution | |
| Fukuoka-Shi, Fukuoka, Japan, 810-0065 | |
| Local Institution | |
| Kitakyushu-Shi, Fukuoka, Japan, 807-8555 | |
| Local Institution | |
| Higashi-Hiroshima-Shi, Hiroshima, Japan, 739-0002 | |
| Local Institution | |
| Sapporo City, Hokkaido, Japan, 060-8648 | |
| Local Institution | |
| Sapporo-City, Hokkaido, Japan, 060-8604 | |
| Local Institution | |
| Sapporo-City, Hokkaido, Japan, 060-0001 | |
| Local Institution | |
| Kanzaki-Gun, Hyogo, Japan, 679-2414 | |
| Local Institution | |
| Kato-Gun, Hyogo, Japan, 673-1462 | |
| Local Institution | |
| Hitachi-Shi, Ibaraki, Japan, 316-0035 | |
| Local Institution | |
| Tsukuba-Shi, Ibaraki, Japan, 305-0005 | |
| Local Institution | |
| Sagamihara-Shi, Kanagawa, Japan, 228-8522 | |
| Local Institution | |
| Sendai, Miyagi, Japan | |
| Local Institution | |
| Sendai-Shi, Miyagi, Japan, 982-0032 | |
| Local Institution | |
| Sendai-Shi, Miyagi, Japan, 981-0911 | |
| Local Institution | |
| Nagano-Shi, Nagano, Japan, 380-8582 | |
| Local Institution | |
| Tsukubo-Gun, Okayama, Japan, 701-0304 | |
| Local Institution | |
| Kawachinagano-Shi, Osaka, Japan, 86-0008 | |
| Local Institution | |
| Ureshino-Shi, Saga, Japan, 843-0301 | |
| Local Institution | |
| Iruma-Gun, Saitama, Japan, 350-0495 | |
| Local Institution | |
| Kawagoe-Shi, Saitama, Japan, 350-8550 | |
| Local Institution | |
| Kitamoto-Shi, Saitama, Japan, 364-0026 | |
| Local Institution | |
| Hamamatsu-Shi, Shizuoka, Japan, 430-0906 | |
| Local Institution | |
| Kawachigun, Tochigi, Japan, 329-1104 | |
| Local Institution | |
| Arakawa-Ku, Tokyo, Japan, 116-0011 | |
| Local Institution | |
| Bunkyo-Ku, Tokyo, Japan, 113-8519 | |
| Local Institution | |
| Bunkyo-Ku, Tokyo, Japan, 113-0022 | |
| Local Institution | |
| Setagaya-Ku, Tokyo, Japan, 155-0032 | |
| Local Institution | |
| Shinjuku-Ku, Tokyo, Japan, 162-0054 | |
| Local Institution | |
| Takaoka-Shi, Toyama, Japan, 933-8525 | |
| Local Institution | |
| Chiba-Shi, Japan, 260-0801 | |
| Local Institution | |
| Tochigi, Japan, 329-0498 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00345748 History of Changes |
| Other Study ID Numbers: | IM101-071 |
| Study First Received: | June 23, 2006 |
| Last Updated: | April 11, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abatacept Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013