A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.

UCB Pharma0 sites54 target enrollmentMay 2005

Overview

Phase: Phase 3
Intervention: Epratuzumab
Conditions: Systemic Lupus Erythematosus
Sponsor: UCB Pharma
Enrollment: 54
Primary Endpoint: Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Status: Terminated
Last Updated: 13 years ago

The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

March 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
•Allergy to human antibodies or Murine.

360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion

Intervention: Epratuzumab

Intravenous

Intervention: Placebo

Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks

Proportion of patients with complete response or partial response;
Individual BILAG assessments;
Physician and patient assessment scores;
Time-to treatment failure;
Successful steroid reduction by weeks 20 and 24;
Maintenance of steroid reduction at 24 and 48 weeks;
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Assess epratuzumab on Health-related quality of life