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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00409838 |
The purpose of the study is to demonstrate the clinical efficacy of abatacept (fixed dose ~ 10mg/kg) compared with placebo on a background of methotrexate after six months of treatment in patients with active RA and an inadequate clinical response to methotrexate
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Placebo Drug: abatacept versus placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate |
Enrollment: | 113 |
Study Start Date: | April 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Placebo Comparator |
Drug: Placebo
solution, intravenous, 0 mg, every 28 days, 6 months and 12 months open-label
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A2: Placebo Comparator |
Drug: abatacept versus placebo
solution, intravenous, 10 mg, every 28 days, 6 months and 12 months open-label
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Local Institution | |
Seoul, Korea, Republic of, 137040 | |
Local Institution | |
Seoul, Korea, Republic of, 110-744 | |
Local Institution | |
Seoul, Korea, Republic of, 138-736 | |
Local Institution | |
Daegu, Korea, Republic of, 705-718 | |
Local Institution | |
Anyang, Korea, Republic of, 431-070 | |
Local Institution | |
Daejeon, Korea, Republic of, 302-799 | |
Korea, Republic of, Sungdong-Gu | |
Local Institution | |
Seoul, Sungdong-Gu, Korea, Republic of, 133-792 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | IM101-124 |
Study First Received: | December 8, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00409838 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Rheumatoid Arthritis, with inadequate response to methotrexate |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Abatacept Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Abatacept Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |