Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

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

Official Title

A Sequential Adaptive 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)

Conditions

Systemic Lupus Erythematosus

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Renal response [Time Frame: Time to occurrence]

Secondary Outcome Measures:

• Proportion of subjects achieving renal response [Time Frame: within 1 year]
• Proportion of subjects maintaining renal response [Time Frame: for at least 3 months]
• Proportion of subjects/time to occurrence of renal improvement (partial response) [Time Frame: within 1 year]
• Change in renal function [Time Frame: within 1 year]
• SLE disease activity/ACR Damage Index Assessment
• Score on quality of life scales
• Safety of abatacept

Study Start

April 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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 6 months of enrollment (screening visit) indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-g (C)]. If renal function has deteriorated, biopsy may have been no more than 3 months prior to enrollment (screening visit)
• 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 within 1 year of screening visit or who have persisting lymphopenia following rituximab at anytime in the past

Total Enrolment

300

Contact Details

For site information, please email: Clinical.Trials@bms.com (First line of email MUST contain “NCT00430677” & Site #. Only trial sites that are recruiting have contact information at this time.)

• Site 058: Westmead, New South Wales, 2145, Australia; Not yet recruiting
• Site 059: Liverpool, New South Wales, 2170, Australia; Not yet recruiting
• Site 061: Brisbane, Queensland, 4102, Australia; Not yet recruiting
• Site 060: Clayton, Victoria, 3168, Australia; Not yet recruiting
• Site 062: Parkville, Victoria, 3050, Australia; Not yet recruiting
• Site 064: Heidelberg, Victoria, 3084, Australia; Not yet recruiting

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