Study of Epratuzumab in Systemic Lupus Erythematosus

November 7, 2011 updated by: UCB Pharma

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
  • Hungary
      • Debrecen, Hungary
  • Netherlands
      • Amsterdam, Netherlands
  • Spain
      • Santander, Spain
  • United Kingdom
      • Birmingham, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Los Angeles, California, United States
      • Upland, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Maryland
      • Baltimore, Maryland, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • South Carolina
      • Charleston, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: Anna Barry, UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 19, 2005

First Submitted That Met QC Criteria

May 19, 2005

First Posted (Estimate)

May 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL0003 (IMMU-103-03)
  • EudraCT #: 2005-000705-59

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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