| February 1, 2007 |
| September 14, 2009 |
| June 2007 |
| October 2010 (final data collection date for primary outcome measure) |
- Renal response - (Double Blind Period) [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ]
- Assess the long term safety and tolerability of abatacept in subjects who have completed the initial 12 month double-blind treatment period on a background of Mycophenolate Mofetil and of tapering glucocorticosteroids - (Open Label Period) [ Time Frame: Open label treatment period ] [ Designated as safety issue: Yes ]
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| Time to occurrence of renal response |
| Complete list of historical versions of study NCT00430677 on ClinicalTrials.gov Archive Site |
- Proportion of subjects achieving renal response - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
- Proportion of subjects maintaining renal response - (Double Blind Period) [ Time Frame: for at least 3 months ] [ Designated as safety issue: No ]
- Proportion of subjects/time to occurrence of renal improvement (partial response) - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
- Change in renal function - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
- SLE disease activity/ACR Damage Index Assessment - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
- Score on quality of life scales - (Double Blind Period) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
- Safety of abatacept [ Time Frame: Double Blind Period ] [ Designated as safety issue: Yes ]
- Assess the durability of efficacy (e.g. complete renal response, renal improvement, SLICC/ACR Damage Index) [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]
- Assess glucocorticosteroid use [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]
- Assess the immunogenicity of abatacept during chronic use [ Time Frame: Open label treatment period ] [ Designated as safety issue: No ]
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- Proportion of subjects achieving renal response within 1 year
- Proportion of subjects maintaining renal response for at least 3 months
- Proportion of subjects/time to occurrence of renal improvement (partial response) within 1 year
- Change in renal function within 1 year
- SLE disease activity/ACR Damage Index Assessment
- Score on quality of life scales
- Safety of abatacept
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| Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis |
| 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) |
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 |
Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study
Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Systemic Lupus Erythematosus |
- Drug: steroids (prednisone or prednisolone) + MMF
- Drug: abatacept
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- Active Comparator: Double Blind Period
- Other: Open Label Period
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| Recruiting |
| 303 |
| October 2010 |
| October 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- SLE as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
- Renal Biopsy within 12 months of randomization (Day 1) indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-g (C)] or WHO 1982 Classification Class III or IV (excluding Class IIIc, IVd).
- Active renal disease at the screening visit, as defined by: urinary protein/creatinine ratio ≥0.5 AND an active urinary sediment as defined by at least one of the following 3 criteria: i) >5 RBC/hpf OR ii) >5 WBC/hpf (with no evidence of a urinary tract infection) OR iii) cylindruria AND
- A Stable serum creatine ≤3 mg/dL
Exclusion Criteria:
- Subjects with a rise in serum creatine of ≥1 mg/dL within 1 month prior to the screening visit
- Subjects with drug-induced SLE, as opposed to idiopathic SLE
- Subjects with severe, unstable and/or progressive CNS lupus
- Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; RA, MS)
- Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
- Subjects who have received treatment with rituximab < 6 months prior to the screening visit
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| Both |
| 18 Years and older |
| No |
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: |
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Clinical.Trials@bms.com |
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| 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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| 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 |
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| NCT00430677 |
| Study Director, Bristol-Myers Squibb |
| IM101-075 |
| Bristol-Myers Squibb |
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| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
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| Bristol-Myers Squibb |
| September 2009 |