None listed
Conditions
Interventions
ALL SUBJECTS ARE REQUIRED TO HAVE A DOCUMENTED DIAGNOSIS OF SLE BY THE ACR CRITERIA AND BIOPSY-PROVEN PROLIFERATIVE LN INTERNATIONAL SOCIETY OF NEPHROLOGY/RENAL PATHOLOGY SOCIETY (ISN/RPS
SEE SECTION 22.1, APPENDIX A) 2003 CLASS III OR IV LN. SUBJECTS ARE PERMITTED TO HAVE CO-EXISTING CLASS V LN. SUBJECTS ARE REQUIRED TO HAVE ACTIVE LN AT SCREENING DEFINED AS UPCR > 1 FOR SUBJECTS WITH
Sponsors
Biogen Idec Research Limited,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. ABILITY TO UNDERSTAND THE PURPOSE AND RISKS OF THE STUDY AND PROVIDE SIGNED AND DATED INFORMED CONSENT AND AUTHORIZATION TO USE PROTECTED HEALTH INFORMATION (PHI) IN ACCORDANCE WITH NATIONAL AND LOCAL SUBJECT PRIVACY REGULATIONS. 2. AGED 18 TO 75 YEARS OLD, INCLUSIVE, AT THE TIME OF INFORMED CONSENT. 3. MUST HAVE A DOCUMENTED DIAGNOSIS OF SLE ACCORDING TO CURRENT ACR CRITERIA (SEE SECTION 22.2 ,APPENDIX B). AT LEAST 4 ACR CRITERIA MUST BE DOCUMENTED, 1 OF WHICH MUST BE A POSITIVE ANTINUCLEAR ANTIBODY (ANA), ANTI-SM, OR ANTI-DSDNA ANTIBODY. 4. MUST HAVE A DIAGNOSIS OF ISN/RPS 2003 CLASS III OR IV LN WITH EITHER ACTIVE OR ACTIVE/CHRONIC DISEASE, CONFIRMED BY BIOPSY WITHIN 3 MONTHS PRIOR TO SCREENING. SUBJECTS ARE PERMITTED TO HAVE CO-EXISTING CLASS V LN. THE LOCAL HISTOLOGICAL DIAGNOSIS MUST BE CONFIRMED BY THE CENTRAL STUDY PATHOLOGIST. 5. MUST HAVE PROTEINURIA AT SCREENING (FROM A 24-HOUR URINE SAMPLE COLLECTION) DEFINED AS: • UPCR > 1.0 IN SUBJECTS WITH BIOPSY CLASS III OR IV LN • UPCR >2.0 IN SUBJECTS WITH CO-EXISTING CLASS V LN
Exclusion criteria
Exclusion criteria: SYSTEMIC LUPUS ERYTHEMATOUS 1. RETINITIS, POORLY-CONTROLLED SEIZURE DISORDER, ACUTE CONFUSIONAL STATE, MYELITIS, STROKE OR STROKE SYNDROME, CEREBELLAR ATAXIA, OR DEMENTIA THAT IS CURRENTLY ACTIVE AND RESULTING FROM SLE AT SCREENING. 2. MOST RECENT RENAL BIOPSY SHOWS > 50% OF GLOMERULI WITH GLOBAL SCLEROSIS. 3. MOST RECENT RENAL BIOPSY SHOWS > 50% INTERSTITIAL DIFFUSE FIBROSIS. 4. ESTIMATED GFR < 30 ML/MIN PER 1.73 M2 (CALCULATED USING THE ABBREVIATED MDRD EQUATION) OR THE PRESENCE OF OLIGURIA OR ESRD REQUIRING DIALYSIS OR TRANSPLANTATION. MEDICAL HISTORY 5. KNOWN TO BE POSITIVE FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) ANTIBODY. 6. HISTORY OF MALIGNANCY OR CARCINOMA IN SITU. HOWEVER, SUBJECTS WITH A HISTORY OF EXCISED OR TREATED BASAL CELL CARCINOMA OR < 3 EXCISED SQUAMOUS CELL CARCINOMAS OF THE SKIN ARE ELIGIBLE TO PARTICIPATE IN THIS STUDY. MOLES OR LESIONS THAT ARE CURRENTLY UNDIAGNOSED, BUT ARE SUSPICIOUS FOR MALIGNANCY, MUST BE EVALUATED BY A DERMATOLOGIST PRIOR TO ASSESSING ELIGIBILITY.
Countries
Argentina, Australia, Belgium, Canada, Colombia, France, Germany, Hungary, Israel, Italy, Korea North, Malasya, Mexico, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, Thailand, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed