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| Descriptive Information Fields | |||||||||
| Brief Title † | Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis | ||||||||
| 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) | ||||||||
| Brief Summary | 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 |
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| Detailed Description | |||||||||
| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Renal response [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Proportion of subjects achieving renal response [ Time Frame: within 1 year ] [ Designated as safety issue: No ] Proportion of subjects maintaining renal response [ Time Frame: for at least 3 months ] [ Designated as safety issue: No ] Proportion of subjects/time to occurrence of renal improvement (partial response) [ Time Frame: within 1 year ] [ Designated as safety issue: No ] Change in renal function [ Time Frame: within 1 year ] [ Designated as safety issue: No ] SLE disease activity/ACR Damage Index Assessment [ Time Frame: within 1 year ] [ Designated as safety issue: No ] Score on quality of life scales [ Time Frame: within 1 year ] [ Designated as safety issue: No ] Safety of abatacept [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ] |
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| Condition † | Systemic Lupus Erythematosus | ||||||||
| Intervention † | Drug: steroids (prednisone or prednisolone) + MMF Drug: abatacept |
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| MEDLINE PMIDs | |||||||||
| Links | BMS Clinical Trials Disclosure ![]() For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 303 | ||||||||
| Start Date † | June 2007 | ||||||||
| Completion Date | June 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Hong Kong, India, Korea, Republic of, Mexico, Poland, Russian Federation, South Africa, Taiwan, Turkey, United Kingdom | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00430677 | ||||||||
| Organization ID | IM101-075 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Bristol-Myers Squibb | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||||||
| Verification Date | November 2008 | ||||||||
| First Received Date † | February 1, 2007 | ||||||||
| Last Updated Date | November 19, 2008 | ||||||||