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| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00430677 |
Purpose
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 |
|
Systemic Lupus Erythematosus |
Drug: steroids (prednisone or prednisolone) + MMF Drug: abatacept |
Phase II Phase III |
| MedlinePlus related topics: | Lupus |
| 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: | 474 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 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
|
| A2: Active Comparator |
Drug: abatacept
intravenous solution, injectable, 10mg/kg or 30 mg/kg, every 28 days, 52 week double blind period
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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. |
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Show 104 Study Locations |
| Bristol-Myers Squibb |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
  |
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | IM101-075 |
| First Received: | February 1, 2007 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00430677 |
| Health Authority: | United States: Food and Drug Administration |
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