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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00119678 |
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, active lupus flares in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints. All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: Abatacept+Prednisone Drug: Placebo + Prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares |
Estimated Enrollment: | 180 |
Study Start Date: | September 2005 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: Abatacept+Prednisone
Injectable + tablets, intravenous + oral, abatacept 10mg/kg prednisone 30mg, abatacept every 28 days prednisone daily for 28 days then taper, 12 months.
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A2: Placebo Comparator |
Drug: Placebo + Prednisone
Injectable + tablets, intravenous + oral, placebo & prednisone 30mg, placebo every 28 days prednisone daily for 28 days then taper, 12 months.
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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:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | IM101-042 |
Study First Received: | June 30, 2005 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00119678 |
Health Authority: | United States: Food and Drug Administration |
SLE |
Prednisone Abatacept Autoimmune Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |
Anti-Inflammatory Agents Immune System Diseases Antineoplastic Agents, Hormonal Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Glucocorticoids Hormones Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Antirheumatic Agents |