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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00430677 |
The purpose of this clinical research study is to learn if abatacept treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and steroids as part of this study will control the nephritis despite a protocol-defined steroid taper; the endpoint is a "complete renal response", a composite including normalization of renal function (or stable normal function if function was normal at study entry) plus disappearance of protein and cells/casts from the urinary sediment. The safety of this treatment will also be studied
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: steroids (prednisone or prednisolone) + MMF Drug: abatacept |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE) |
Estimated Enrollment: | 303 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: steroids (prednisone or prednisolone) + MMF
tablets, oral, 0.5-0.8 mg/kg + 2-3g, daily, 52 week double blind period
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A2: Active Comparator |
Drug: abatacept
intravenous solution, injectable, 10mg/kg or 30 mg/kg, every 28 days, 52 week double blind period
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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:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | IM101-075 |
Study First Received: | February 1, 2007 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00430677 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Prednisone Glomerulonephritis Autoimmune Diseases Immunologic Factors Antineoplastic Agents, Hormonal Methylprednisolone Lupus Nephritis Hormone Antagonists Lupus Hormones, Hormone Substitutes, and Hormone Antagonists Methylprednisolone acetate |
Prednisolone acetate Immunosuppressive Agents Hormones Glucocorticoids Abatacept Lupus Erythematosus, Systemic Nephritis Prednisolone Mycophenolate mofetil Connective Tissue Diseases Antirheumatic Agents Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Autoimmune Diseases Immunologic Factors Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents |
Glucocorticoids Hormones Pharmacologic Actions Abatacept Lupus Erythematosus, Systemic Therapeutic Uses Prednisolone Connective Tissue Diseases Antirheumatic Agents |