Back to resultsEfficacy and Safety of Belimumab in SLE Patients
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Belimumab
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring Belimumab, Systemic Lupus Erythematosus, Disease flare
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years;
- Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
- A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
- Sign the informed consent;
Exclusion Criteria:
- Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits;
- Creatinine clearance rate < 60ml/min;
- Exposure to cyclophosphamide within past 6 months before screening;
- Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
- History of Malignancy;
- History of herpes zoster with past 3 months before screening.
- Chronic HBV/HCV hepatitis；
- Current infections (HIV/tuberculosis)
Sites / Locations
- Shuang Ye, MDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Belimumab 2mg/kg
Placebo
Arm Description
Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Belimumab 2mg/kg is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Placebo (normal saline) is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Outcomes
Primary Outcome Measures
Percentage of patients with disease flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Secondary Outcome Measures
Percentage of patients with mild/moderate flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Percentage of patients with major flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time to first disease flare
Time to first disease flare
prednisone dose at each visit
compare the prednisone dose at each visit
SELENA-SLEDAI score at each visit
compare the disease activity measured by SELENA-SLEDAI score at each visit
BiLAG score at each visit
compare the disease activity measured by BILAG score at each visit
The percentage of patients achieving prednisone-free successfully
the percentage of patients achieving prednisone-free successfully
Number of participants with adverse events as assessed by CTCAE v4.0
the safety of belimumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04515719
Brief Title
Efficacy and Safety of Belimumab in SLE Patients
Official Title
Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Its pathogenesis is still unclear, but B cells have been confirmed to play a vital role in it. Belimumab, a B-lymphocyte stimulating factor (Blys) inhibitor, was the only FDA-approved biological agent for SLE. BLISS-52 showed that more active lupus patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 10 mg/kg (58% vs 46%, p=0·0024) than with placebo. But there was limited data about belimumab in SLE patients with low disease activity. Our previous study indicated that even these patients still have an annual flare rate of 30-40%. Therefore, we try to explore whether low-dose of belimumab could prevent the disease flares in SLE patients with low disease activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Belimumab, Systemic Lupus Erythematosus, Disease flare
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Belimumab 2mg/kg
Arm Type
Experimental
Arm Description
Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Belimumab 2mg/kg is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Placebo (normal saline) is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Intervention Type
Biological
Intervention Name(s)
Belimumab
Other Intervention Name(s)
BENLYSTA™
Intervention Description
Belimumab 2mg/kg intravenously
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenously
Primary Outcome Measure Information:
Title
Percentage of patients with disease flares
Description
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients with mild/moderate flares
Description
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time Frame
52 weeks
Title
Percentage of patients with major flares
Description
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time Frame
52 weeks
Title
Time to first disease flare
Description
Time to first disease flare
Time Frame
52 weeks
Title
prednisone dose at each visit
Description
compare the prednisone dose at each visit
Time Frame
52 weeks
Title
SELENA-SLEDAI score at each visit
Description
compare the disease activity measured by SELENA-SLEDAI score at each visit
Time Frame
52 weeks
Title
BiLAG score at each visit
Description
compare the disease activity measured by BILAG score at each visit
Time Frame
52 weeks
Title
The percentage of patients achieving prednisone-free successfully
Description
the percentage of patients achieving prednisone-free successfully
Time Frame
52 weeks
Title
Number of participants with adverse events as assessed by CTCAE v4.0
Description
the safety of belimumab
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Subgroup analysis
Description
subgroup analysis aiming to investigate which population will benefit most from belimumab with prespecified factors including age, gender, SLE duration, SELENA- SLEDAI, BILAG, PGA, serology, baseline LLDAS attainment and prednisone dose.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years;
Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
Sign the informed consent;
Exclusion Criteria:
Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits;
Creatinine clearance rate < 60ml/min;
Exposure to cyclophosphamide within past 6 months before screening;
Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
History of Malignancy;
History of herpes zoster with past 3 months before screening.
Chronic HBV/HCV hepatitis；
Current infections (HIV/tuberculosis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangfang Sun
Phone
86-021-34506393
Email
fiona_rj@163.com
Facility Information:
Facility Name
Shuang Ye, MD
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuang Ye, MD
Phone
+8613817615871
Email
ye_shuang2000@163.com
First Name & Middle Initial & Last Name & Degree
Huijing Wang, postgraduate
Phone
+8618267851823
Email
whj30813@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
21296403
Citation
Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, Leon MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. doi: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4.
Results Reference
background
PubMed Identifier
35105722
Citation
Sun F, Huang W, Chen J, Zhao L, Zhang D, Wang X, Wan W, Dai SM, Chen S, Li T, Ye S. Low-dose belimumab for patients with systemic lupus erythematosus at low disease activity: protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. Lupus Sci Med. 2022 Feb;9(1):e000638. doi: 10.1136/lupus-2021-000638.
Results Reference
derived
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Efficacy and Safety of Belimumab in SLE Patients
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