Back to resultsOpen-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 2
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, Monoclonal antibody, B-Cell immunotherapy
Eligibility Criteria
Inclusion Criteria:
- SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
- Patients must have maintained eligibility requirements throughout their participation in SL0007
- Written informed consent signed prior to initiation of any study-specific assessments at visit 1
Exclusion Criteria:
- Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
- Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
- Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
- Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
- Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EMAB
Arm Description
1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
Outcomes
Primary Outcome Measures
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
Secondary Outcome Measures
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
The combined response index including an additional criteria involving the SF-36 response
BILAG score assessment
SLEDAI scores assessment
Patient and physician VAS
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
SF-36 PCS, MCS
EQ-5D results
Proportion of patients meeting treatment failure
Total daily steroid dose
Time to flare for patients who entered the study without flare as defined by the BILAG
SLEDAI responder
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
Immunogenicity as measured by human anti-human antibodies
Assessment of changes in baseline in levels of circulating B and T cells
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00660881
Brief Title
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
Official Title
A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (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 primary objective of the study is to assess the safety of epratuzumab in 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, Monoclonal 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
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMAB
Arm Type
Experimental
Arm Description
1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
Intervention Type
Biological
Intervention Name(s)
Epratuzumab
Intervention Description
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.
Primary Outcome Measure Information:
Title
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
Time Frame
12 Week treatment cycles
Secondary Outcome Measure Information:
Title
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
Time Frame
Every 4 weeks through week 48, then every 12 weeks through completion
Title
The combined response index including an additional criteria involving the SF-36 response
Time Frame
Every 12 weeks
Title
BILAG score assessment
Time Frame
Every 4 weeks through week 48, then every 12 weeks through completion
Title
SLEDAI scores assessment
Time Frame
Every 4 weeks through week 48, then every 12 weeks through completion
Title
Patient and physician VAS
Time Frame
Every 4 weeks through week 48, then every 12 weeks through completion
Title
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
Time Frame
Every 12 weeks
Title
SF-36 PCS, MCS
Time Frame
Every 12 weeks
Title
EQ-5D results
Time Frame
Every 12 weeks
Title
Proportion of patients meeting treatment failure
Time Frame
Every 12 weeks
Title
Total daily steroid dose
Time Frame
Every 4 weeks for the first 48 weeks and then every 12 weeks
Title
Time to flare for patients who entered the study without flare as defined by the BILAG
Time Frame
over the entire course of the trial
Title
SLEDAI responder
Time Frame
Every 4 weeks for the first 48 weeks and then every 12 weeks
Title
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
Time Frame
over the entire course of the trial
Title
Immunogenicity as measured by human anti-human antibodies
Time Frame
at each dosing visit and 4 weeks post first dose of each treatment cycle
Title
Assessment of changes in baseline in levels of circulating B and T cells
Time Frame
The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
Patients must have maintained eligibility requirements throughout their participation in SL0007
Written informed consent signed prior to initiation of any study-specific assessments at visit 1
Exclusion Criteria:
Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an 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
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Leandro
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Farmington
State/Province
Connecticut
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Brussels
Country
Belgium
City
Leuven
Country
Belgium
City
Goiania
State/Province
GO
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Shatin
Country
Hong Kong
City
Debrecen
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Madurai
State/Province
Tamilnadu
Country
India
City
Bangalore
Country
India
City
Hyderabad
Country
India
City
Manipal
Country
India
City
Nagpur
Country
India
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Elblag
Country
Poland
City
Konskie
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Torun
Country
Poland
City
Barcelona
Country
Spain
City
Santander
Country
Spain
City
Donetsk
Country
Ukraine
City
Ivano-Frankivsk
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lviv
Country
Ukraine
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
PubMed Identifier
26316325
Citation
Wallace DJ, Hobbs K, Clowse ME, Petri M, Strand V, Pike M, Merrill JT, Leszczynski P, Neuwelt CM, Jeka S, Houssiau F, Keiserman M, Ordi-Ros J, Bongardt S, Kilgallen B, Galateanu C, Kalunian K, Furie R, Gordon C. Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study. Arthritis Care Res (Hoboken). 2016 Apr;68(4):534-43. doi: 10.1002/acr.22694.
Results Reference
derived
Learn more about this trial
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
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