Back to resultsStudy of Epratuzumab in Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 2
Locations
United States
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 participated in SL0003 or SL0004 and benefitted from participation in those studies
Exclusion Criteria:
- Development of toxicity to epratuzumab
- Significant protocol deviations during the SL0003 or SL0004 studies
- Evidence of significant infection
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epratuzumab
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
Secondary Outcome Measures
Time to treatment failure from First Visit through end of treatment (approximately 6 years)
Treatment failure is defined as initiation of a protocol specified prohibited medication.
Epratuzumab plasma concentration levels at Week 0
Epratuzumab plasma concentration levels at Week 48
Epratuzumab plasma concentration levels at Week 96
Epratuzumab plasma concentration levels at Week 144
Epratuzumab plasma concentration levels at Week 192
Epratuzumab plasma concentration levels at Week 240
Subject Epratuzumab plasma concentration levels at Week 288
Number of subjects with anti-epratuzumab antibody in plasma at Week 0
Number of subjects with anti-epratuzumab antibody in plasma at Week 48
Number of subjects with anti-epratuzumab antibody in plasma at Week 96
Number of subjects with anti-epratuzumab antibody in plasma at Week 144
Number of subjects with anti-epratuzumab antibody in plasma at Week 192
Number of subjects with anti-epratuzumab antibody in plasma at Week 240
Number of subjects with anti-epratuzumab antibody in plasma at Week 288
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score
Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score
Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)
Five point scale where 1 = very poor and 5 = very good.
Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)
Five point scale where 1 = very poor and 5 = very good.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00383513
Brief Title
Study of Epratuzumab in Systemic Lupus Erythematosus
Official Title
An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
Detailed Description
Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epratuzumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Epratuzumab
Intervention Description
360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour
Primary Outcome Measure Information:
Title
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
Time Frame
From Entry Visit 1 through end of treatment (approximately 6 years)
Title
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
Time Frame
From Entry Visit 1 through end of treatment (approximately 6 years)
Secondary Outcome Measure Information:
Title
Time to treatment failure from First Visit through end of treatment (approximately 6 years)
Description
Treatment failure is defined as initiation of a protocol specified prohibited medication.
Time Frame
From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years)
Title
Epratuzumab plasma concentration levels at Week 0
Time Frame
Week 0
Title
Epratuzumab plasma concentration levels at Week 48
Time Frame
Week 48
Title
Epratuzumab plasma concentration levels at Week 96
Time Frame
Week 96
Title
Epratuzumab plasma concentration levels at Week 144
Time Frame
Week 144
Title
Epratuzumab plasma concentration levels at Week 192
Time Frame
Week 192
Title
Epratuzumab plasma concentration levels at Week 240
Time Frame
Week 240
Title
Subject Epratuzumab plasma concentration levels at Week 288
Time Frame
Week 288
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 0
Time Frame
Week 0
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 48
Time Frame
Week 48
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 96
Time Frame
Week 96
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 144
Time Frame
Week 144
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 192
Time Frame
Week 192
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 240
Time Frame
Week 240
Title
Number of subjects with anti-epratuzumab antibody in plasma at Week 288
Time Frame
Week 288
Title
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score
Time Frame
Baseline, Last Visit
Title
Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score
Time Frame
Baseline, Last Visit
Title
Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)
Description
Five point scale where 1 = very poor and 5 = very good.
Time Frame
Baseline, Last Visit
Title
Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)
Description
Five point scale where 1 = very poor and 5 = very good.
Time Frame
Baseline, Last Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have participated in SL0003 or SL0004 and benefitted from participation in those studies
Exclusion Criteria:
Development of toxicity to epratuzumab
Significant protocol deviations during the SL0003 or SL0004 studies
Evidence of significant infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
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
Washington
State/Province
District of Columbia
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Epratuzumab in Systemic Lupus Erythematosus
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