Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 coincident. The 4 criteria need not be present at study entry
Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria \[2003\], excluding Class III \[C\], IV-S \[C\] and IV-G \[C\], or the World Health Organization Class III or IV classification criteria \[1982\], excluding Class IIIc, IVd). If the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA \>upper limit of normal range.
A stable serum creatinine ≤3 mg/dL
You may not be if
Subjects with a rise in serum creatinine 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 Central nervous system (CNS) lupus
Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis \[MS\])
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
Clareo Health | Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
