Back to resultsStudy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 2
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, Monoclonal antibody, B-Cell immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Positive ANA result at visit 1
- Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
- Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
- If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
Exclusion Criteria:
- Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
EMAB 600mg
EMAB 100mg
EMAB 400mg
EMAB 1200mg
EMAB 1800mg
Arm Description
Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Outcomes
Primary Outcome Measures
Response at Week 12 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Secondary Outcome Measures
Response at Week 4 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Response at Week 8 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
Change from baseline in physician global assessment at Week 12
Change from baseline in patient global assessment at Week 12
Short Form-36 (SF-36) response at Week 2
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores.
Short Form-36 (SF-36) response at Week 4
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Short Form-36 (SF-36) response at Week 8
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Short Form-36 (SF-36) response at Week 12
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
Time to first sustained British Isles Lupus Assessment Group (BILAG) response
Time to enhanced British Isles Lupus Assessment Group (BILAG) response
Treatment failure up to Week 12
Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.
Cumulative steroid dose at Week 12
Human anti-human antibodies (HAHA) levels at Week 12
Change from baseline in levels of circulating B cells at Week 12
Change from baseline in levels of circulating T cells at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00624351
Brief Title
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
Official Title
A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (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
The primary objective of the study is to assess the dose response and the dose frequency 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
Arm Title
EMAB 600mg
Arm Type
Experimental
Arm Description
600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
Arm Title
EMAB 100mg
Arm Type
Experimental
Arm Description
100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Arm Title
EMAB 400mg
Arm Type
Experimental
Arm Description
400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Arm Title
EMAB 1200mg
Arm Type
Experimental
Arm Description
1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Arm Title
EMAB 1800mg
Arm Type
Experimental
Arm Description
1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
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 Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Phosphate-buffered Saline (PBS) infusion.
Primary Outcome Measure Information:
Title
Response at Week 12 according to a combined response index
Description
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Response at Week 4 according to a combined response index
Description
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Time Frame
Week 4
Title
Response at Week 8 according to a combined response index
Description
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Time Frame
Week 8
Title
Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
Description
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Time Frame
Week 4
Title
Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
Description
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Time Frame
Week 8
Title
Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
Description
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Time Frame
Week 12
Title
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
Time Frame
Baseline, Week 4
Title
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
Time Frame
Baseline, Week 8
Title
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
Time Frame
Baseline, Week 12
Title
Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
Time Frame
Baseline, Week 24
Title
Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
Time Frame
Baseline, Week 12
Title
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
Time Frame
Baseline, Week 2
Title
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
Time Frame
Baseline, Week 4
Title
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
Time Frame
Baseline, Week 8
Title
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
Time Frame
Baseline, Week 12
Title
Change from baseline in physician global assessment at Week 12
Time Frame
Baseline, Week 12
Title
Change from baseline in patient global assessment at Week 12
Time Frame
Baseline, Week 12
Title
Short Form-36 (SF-36) response at Week 2
Description
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores.
Time Frame
Baseline, Week 2
Title
Short Form-36 (SF-36) response at Week 4
Description
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Time Frame
Baseline, Week 4
Title
Short Form-36 (SF-36) response at Week 8
Description
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Time Frame
Baseline, Week 8
Title
Short Form-36 (SF-36) response at Week 12
Description
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or > -2.5 changes in any of the 8 domain scores
Time Frame
Baseline, Week 12
Title
European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
Time Frame
Week 12
Title
Time to first sustained British Isles Lupus Assessment Group (BILAG) response
Time Frame
From Baseline to Week 12
Title
Time to enhanced British Isles Lupus Assessment Group (BILAG) response
Time Frame
From Baseline to Week 12
Title
Treatment failure up to Week 12
Description
Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.
Time Frame
From Baseline to Week 12
Title
Cumulative steroid dose at Week 12
Time Frame
From Baseline to Week 12
Title
Human anti-human antibodies (HAHA) levels at Week 12
Time Frame
Week 12
Title
Change from baseline in levels of circulating B cells at Week 12
Time Frame
Baseline, Week 12
Title
Change from baseline in levels of circulating T cells at Week 12
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive ANA result at visit 1
Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
Exclusion Criteria:
Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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
Aventura
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Brooklyn
State/Province
New York
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
Dallas
State/Province
Texas
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Brussels
Country
Belgium
City
Leuven
Country
Belgium
City
Curitiba
Country
Brazil
City
Goiania
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Sorocaba
Country
Brazil
City
Chai Wan
Country
Hong Kong
City
Shatin
Country
Hong Kong
City
Debrecen
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Bangalore
Country
India
City
Hyderabad
Country
India
City
Ludhiana
Country
India
City
Madurai
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
Poznań
Country
Poland
City
Torun
Country
Poland
City
Barcelona
Country
Spain
City
Santander
Country
Spain
City
Valencia
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
23313811
Citation
Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90. doi: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12.
Results Reference
derived
Learn more about this trial
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
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