Study of Epratuzumab in Systemic Lupus Erythematosus

Phase 3

Terminated

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00111306
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-19
• Study First Submitted QC: 2005-05-19
• Study First Posted: 2005-05-20
• Study Start: 2005-06
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

• 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

Exclusion Criteria

• Active severe CNS or Renal disease defined by BILAG as Level A
• Allergy to murine or human antibodies
• Antiphospholid antibodies AND a history of thrombocytopenic events

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.

Secondary Outcome Measures

Name	Time	Method
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.