Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Phase 3

Terminated

• Conditions: Systemic Lupus Erythematosus
• Interventions: Other: Placebo; Drug: Epratuzumab

• Registration Number: NCT00383214
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-03
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• +ANA at screening
• BILAG Index B Level Activity in at least 2 body systems/organs
• Has SLE by ACR revised criteria (meets,<4 criteria)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intravenous
Epratuzumab	Epratuzumab	360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion

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