- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515719
Efficacy and Safety of Belimumab in SLE Patients
June 6, 2022 updated by: RenJi Hospital
Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
334
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fangfang Sun
- Phone Number: 86-021-34506393
- Email: fiona_rj@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Shuang Ye, MD
-
Contact:
- Huijing Wang, postgraduate
- Phone Number: +8618267851823
- Email: whj30813@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Belimumab 2mg/kg
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.
|
Belimumab 2mg/kg intravenously
Other Names:
|
Placebo Comparator: Placebo
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.
|
Placebo intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with disease flares
Time Frame: 52 weeks
|
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with mild/moderate flares
Time Frame: 52 weeks
|
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
|
52 weeks
|
Percentage of patients with major flares
Time Frame: 52 weeks
|
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
|
52 weeks
|
Time to first disease flare
Time Frame: 52 weeks
|
Time to first disease flare
|
52 weeks
|
prednisone dose at each visit
Time Frame: 52 weeks
|
compare the prednisone dose at each visit
|
52 weeks
|
SELENA-SLEDAI score at each visit
Time Frame: 52 weeks
|
compare the disease activity measured by SELENA-SLEDAI score at each visit
|
52 weeks
|
BiLAG score at each visit
Time Frame: 52 weeks
|
compare the disease activity measured by BILAG score at each visit
|
52 weeks
|
The percentage of patients achieving prednisone-free successfully
Time Frame: 52 weeks
|
the percentage of patients achieving prednisone-free successfully
|
52 weeks
|
Number of participants with adverse events as assessed by CTCAE v4.0
Time Frame: 52 weeks
|
the safety of belimumab
|
52 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subgroup analysis
Time Frame: 52 weeks
|
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.
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2021
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Btrial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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