Back to resultsStudy of Epratuzumab in Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Terminated
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: 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
Sites / Locations
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
NCT00111306
Brief Title
Study of Epratuzumab in Systemic Lupus Erythematosus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Study Start Date
June 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
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety & 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
510 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
epratuzumab
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:
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
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
Denver
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
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
Durham
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Brussels
Country
Belgium
City
Debrecen
Country
Hungary
City
Amsterdam
Country
Netherlands
City
Santander
Country
Spain
City
Birmingham
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
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