A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

UCB Pharma0 sites510 target enrollmentJune 2005

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Systemic Lupus Erythematosus
Sponsor: UCB Pharma
Enrollment: 510
Primary Endpoint: Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.
Status: Terminated
Last Updated: 14 years ago

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

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

March 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Has SLE by ACR revised criteria (meets \<4 criteria);
•Has SLE with at least one elevated lupus antibody;
•Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

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.