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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00345748
First received: June 23, 2006
Last updated: April 11, 2011
Last verified: April 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 060-0001
Local Institution
Sapporo-City, Hokkaido, Japan, 060-8604
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, 981-0911
Local Institution
Sendai-Shi, Miyagi, Japan, 982-0032
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, 113-0022
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
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abatacept
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014