Study of Epratuzumab in Systemic Lupus Erythematosus

Phase 3

Withdrawn

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00382837
• Lead Sponsor: UCB Pharma

Brief Summary

Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-02
• Study Start: 2007-01
• Status Verified: 2007-03
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria

• Development of toxicity to Epratuzumab
• Significant protocol deviations from SL0003 Study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.

Secondary Outcome Measures

Name	Time	Method
To continue to assess the efficacy and tolerability of epratuzumab;
To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
To continue to assess epratuzumab on Health-related quality of life in lupus patients;
To continue to assess disease status as reported by the patient and physician.