Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis - NCT00430677-37909 (Clinical Trial 161829)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy161829.aspx
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| City: |
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Knoxville |
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State:
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TN |
| Zip Code: |
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37909 |
| Conditions: |
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Systemic Lupus Erythematosus |
| Purpose: |
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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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| Study summary: |
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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 |
| Criteria: |
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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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| Study is available at: |
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Rheumatology Consultants Pllc
Knoxville, TN 37909
United States
Primary Contact:
Richard Misischia, Site 029
Phone: 865-602-7983
Secondary Contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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