Back to resultsStudy of Epratuzumab in Systemic Lupus Erythematosus (SLE)
Primary Purpose
Systemic Lupus Erythematosus
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epratuzumab
Placebo
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:
- +ANA at screening
- BILAG Index B Level Activity in at least 2 body systems/organs
- Has SLE by ACR revised criteria (meets,<4 criteria)
Exclusion Criteria:
- Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
- Allergy to human antibodies or Murine.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Epratuzumab
Placebo
Arm Description
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Intravenous
Outcomes
Primary Outcome Measures
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00383214
Brief Title
Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
Official Title
A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.
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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epratuzumab
Arm Type
Active Comparator
Arm Description
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Epratuzumab
Intervention Description
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with complete response or partial response;
Title
Individual BILAG assessments;
Title
Physician and patient assessment scores;
Title
Time-to treatment failure;
Title
Successful steroid reduction by weeks 20 and 24;
Title
Maintenance of steroid reduction at 24 and 48 weeks;
Title
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Title
Assess epratuzumab on Health-related quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Exclusion Criteria:
Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
Allergy to human antibodies or Murine.
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
Colorado Springs
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
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
Plainview
State/Province
New York
Country
United States
City
Rochester
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
Philadelphia
State/Province
Pennsylvania
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
Sorocaba
Country
Brazil
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
St John's
State/Province
Newfoundland and Labrador
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
Ancona
Country
Italy
City
Brescia
Country
Italy
City
Amsterdam
Country
Netherlands
City
Groningen
Country
Netherlands
City
Leiden
Country
Netherlands
City
Barcelona
Country
Spain
City
La Laguna
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
City
United Kingdom
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
Learn more about this trial
Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
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