Back to resultsStudy of Epratuzumab in Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epratuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus,, Antibody,, B-Cell immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Must have completed SL0003 Alleviate A through 48 weeks
Exclusion Criteria:
- Development of toxicity to Epratuzumab
- Significant protocol deviations from SL0003 Study.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00382837
Brief Title
Study of Epratuzumab in Systemic Lupus Erythematosus
Official Title
A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Withdrawn
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus,, Antibody,, B-Cell immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Epratuzumab
Primary Outcome Measure Information:
Title
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
Secondary Outcome Measure Information:
Title
To continue to assess the efficacy and tolerability of epratuzumab;
Title
To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Title
To continue to assess epratuzumab on Health-related quality of life in lupus patients;
Title
To continue to assess disease status as reported by the patient and physician.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have completed SL0003 Alleviate A through 48 weeks
Exclusion Criteria:
Development of toxicity to Epratuzumab
Significant protocol deviations from SL0003 Study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Barry
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Upland
State/Province
California
Country
United States
City
Farmington
State/Province
Connecticut
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Gallipolis
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Edmonds
State/Province
Washington
Country
United States
City
Brussels
Country
Belgium
City
Liege
Country
Belgium
City
Rio De Janeiro
State/Province
RJ
Country
Brazil
City
Goiania
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Hradec Kralove
Country
Czech Republic
City
Olomouc
Country
Czech Republic
City
Praha 2
Country
Czech Republic
City
Paris
Country
France
City
Toulouse Cedex 9
Country
France
City
Erlangen
Country
Germany
City
Heidelberg
Country
Germany
City
Mannheim
Country
Germany
City
München
Country
Germany
City
Debrecen
Country
Hungary
City
Pecs
Country
Hungary
City
Ancona
Country
Italy
City
Brescia
Country
Italy
City
Amsterdam
Country
Netherlands
City
Groningen
Country
Netherlands
City
Leiden
Country
Netherlands
City
Piestany
Country
Slovakia
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Santander
Country
Spain
City
Sevilla
Country
Spain
City
Leeds
State/Province
West Yorkshire
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Newcastle Upon Tyne
Country
United Kingdom
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Epratuzumab in Systemic Lupus Erythematosus
We'll reach out to this number within 24 hrs