Lupus Nephritis
Conditions
Interventions
investigational material(s)
Generic name etc : Experimental: BMS-188667 + Mycophenolate mofetil + Prednisone
INN of investigational material : Abatacept
Therapeutic category code : 399 Agents affecti
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major Inclusion criteria: a) Systemic Lupus Erythematosus (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 coincidentally. b) Urine protein creatinine ratio (UPCR) 1.0 or more than 1.0 at Screening. c) Biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis International Society of Nephrology (ISN)/ Renal Pathology Society (RPS) 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-G (C)] or World Health Organization (WHO) 1982 Classification Class III or IV (excluding IIIc, IVd). d) Evidence of active disease within 3 months of Screening. e) Serum creatinine 3 or less than 3 mg/dL.
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: a) Subjects with drug-induced SLE, as opposed to idiopathic SLE. b) Subjects with autoimmune disease other than SLE as their main diagnosis. c) Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study. d) Active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive dysfunction [screening Magnetic Resonating Imaging (MRI) or other imaging of the brain is not required to rule-out CNS disease in subjects who have no clinical features suggesting active CNS disease]. e) Subjects who are diagnosed as end-stage renal disease. f) Subjects with persistent non-lupus related pyuria or hematuria (eg, hemorrhagic cystitis). g) Subjects with a degree of tubulo-interstitial changes that suggests a significant and irreversible decrease in renal function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Complete Response of renal disease Proportion of subjects achieving Complete Response of renal disease following 52 weeks of treatment, where complete response is a composite endpoint based on renal function, proteinuria, urine sediment, and corticosteroid dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Proportion of subjects with CR, PR(partial renal response), NR(no response). Time to achieving first CR, PR. Proportion of subjects meeting each of the components of PR and CR of response. Proportion of subjects meeting each of the components of Partial response (PR) and Complete renal response (CR) of response. British Isles Lupus Assessment Group (BILAG) 2004. etc. Major Secondary Outcome Measures: Proportion of subjects with ranked outcome of partial renal response and no response at Day 365. Proportion of subjects in complete renal response of lupus glomerulonephritis at Day 729. Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response at Day 729. Time to achieving first complete renal response. Time to achieving first partial renal response. Proportion of subjects meeting each of the components of PR and CR of response. Mean change from baseline in disease activity as measured by British Isles Lupus Assessment Group (BILAG) 2004 at Day 365 etc. | — |
Countries
Japan, North America
Outcome results
None listed