None listed
Conditions
Interventions
THE PRIMARY ENDPOINT WILL BE ASSESSED AT DAY 365. THEREAFTER, SUBJECTS WHO CONTINUE TO MEET CRITERIA FOR PARTICIPATION WILL REMAIN ON BLINDED TREATMENT FOR AN ADDITIONAL 52 WEEKS TO ASSESS IMPROMEVENT
VS BLACK, AFRICAN DESCENT OR AFRICAN AMERICAN
VS CAUCASIAN OR OTHER
AND BY THE USE OF ACEI/ARBS
(ONGOING USE OF ACEI/ARBS OR NO ONGOING USE OF ACEI/ARBS). ALL SUBJECTS WILL ALSO RECEIVE THERAPY WITH MMF AT STABLE DOSES DETAILED IN SECTION 4.3.3. ALL SUBJECTS WILL RECEIVE TREATMENT WITH HIGH DOSE
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT 2) TARGET POPULATION A) 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. THE 4 CRITERIA NEED NOT BE PRESENT AT THE TIME OF STUDY ENTRY (SEE APPENDIX 1). B) URINE PROTEIN CREATININE RATIO (UPCR) ≥ 1.0 AT SCREENING C) BIOPSY WITHIN 12 MONTHS PRIOR TO 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)] OR WHO 1982 CLASSIFICATION CLASS III OR IV (EXCLUDING IIIC, IVD) (SEE APPENDIX 2). NOTE: IF NO PRIOR BIOPSY WAS DONE FOR THE SUBJECT AT THE TIME OF THE SCREENING VISIT YET, THE PROCEDURE CAN BE PERFORMED DURING THE SCREENING PERIOD AS A STUDY PROCEDURE ONLY AFTER THE SUBJECT MEETS ALL OTHER INCLUSION AND EXCLUSION CRITERIA. D) EVIDENCE OF ACTIVE DISEASE WITHIN 3 MONTHS OF SCREENING, BASED ON AT LEAST ONE OF THE FOLLOWING: I) RENAL FLARE (DEFINED IN SECTION 5.4.1.4) II) UPCR > 3 AT SCREENING III) ACTIVE URINE SEDIMENT, DEFINED AS AT LEAST ONE OF THE FOLLOWING:
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE A) SUBJECTS WITH DRUG-INDUCED SLE, AS OPPOSED TO IDIOPATHIC SLE. B) SUBJECTS WHO ARE RENAL TRANSPLANT RECIPIENTS OR CANDIDATES. C) SUBJECTS WHO ARE DIAGNOSED AS END-STAGE RENAL DISEASE. D) SUBJECTS WITH PERSISTENT NON-LUPUS RELATED PYURIA OR HEMATURIA (EG, HEMORRHAGIC CYSTITIS). E) SUBJECTS WITH A DEGREE OF TUBULO-INTERSTITIAL CHANGES THAT SUGGESTS A SIGNIFICANT AND IRREVERSIBLE DECREASE IN RENAL FUNCTION. 3) MEDICAL HISTORY AND CONCURRENT DISEASES A) SUBJECTS WITH AUTOIMMUNE DISEASE OTHER THAN SLE AS THEIR MAIN DIAGNOSIS [EG; RHEUMATOID ARTHRITIS (RA), MULTIPLE SCLEROSIS (MS)]. B) 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. C) ACTIVE CNS LUPUS (BILAG A OR B) WITH THE EXCEPTION OF FATIGUE OR MILD STABLE COGNITIVE DYSFUNCTION (SCREENING 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).
Countries
Argentina, Australia, Canada, Chile, Czech Republic, India, Italy, Japan, Mexico, Taiwan, United States
Contacts
Public ContactSTELA LOPEZ
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed