Case Study
Recruitment of Patientsin a Phase III Systemic Lupus Erythematosus Study
Study Overview: During the planning of a Phase III Systemic Lupus Erythematosus (SLE) anti-B cell therapy, the Sponsor company called on Pharm-Olam to assist in the identification and enrollment of patients. The purpose of the study was to determine the viability of a biological agent in treating SLE patients whose disease state was severe, aggressively advancing and poorly controlled. SLE is a notoriously difficult-to-diagnose autoimmune disorder with no known cure. A detailed feasibility study, conducted by Pharm-Olam, identified new geographies with patient populations and disease profiles suitable to meeting the trial’s urgent enrollment goals. Furthermore, Pharm-Olam recognized that Site-CRA relationships would be instrumental in meeting patient enrollment goals. The ass