Systems-wide Temporal Observation of Patients with Systemic Lupus Erythematosus (STOP SLE)
Principal Investigator: Will Pendergraft, MD, PhD
Sponsors: Broad Institute of Harvard and MIT, EMD Serono Inc., Pfizer, Inc.
Age Range: 15 and older
Purpose: The purpose of this study is to understand response to treatment in patients with systemic lupus erythematosus (SLE) by analyzing known and unknown factors in blood and urine over time. All participants will be females with a new biopsy-proven diagnosis of lupus nephritis with planned induction protocol of corticosteroids and cyclophosphamide followed by MMF (Cellcept) for maintenance therapy.
Study Procedures: Participants will receive their induction and maintenance therapy. Blood and urine samples will be collected as follows: Prior to any treatment, at 6 time points on the day of the first cyclophosphamide infusion, and single samples at day 2, week 2, week 4, week 8, week 12, week 16, week 20 and week 24.
Participation: Most samples will be collected at routine clinic visits. However, the timed sampling at the first cyclophosphamide infusion visit will take place in the Clinical and Translational Research Center at UNC Hospitals and will last about 8 hours.
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