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Efficacy and Safety of Belimumab in SLE Patients

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ClinicalTrials.gov Identifier: NCT04515719
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Belimumab Biological: Placebo Phase 4

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 Design
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Study Type : Interventional
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Arms and Interventions
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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.
 Biological: Belimumab
Belimumab 2mg/kg intravenously
Other Name: BENLYSTA™
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.
 Biological: Placebo
Placebo intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with disease flares [ Time Frame: 52 weeks ]
    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).


Secondary Outcome Measures :
  1. Percentage of patients with mild/moderate flares [ Time Frame: 52 weeks ]
    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

  2. Percentage of patients with major flares [ Time Frame: 52 weeks ]
    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

  3. Time to first disease flare [ Time Frame: 52 weeks ]
    Time to first disease flare

  4. prednisone dose at each visit [ Time Frame: 52 weeks ]
    compare the prednisone dose at each visit

  5. SELENA-SLEDAI score at each visit [ Time Frame: 52 weeks ]
    compare the disease activity measured by SELENA-SLEDAI score at each visit

  6. BiLAG score at each visit [ Time Frame: 52 weeks ]
    compare the disease activity measured by BILAG score at each visit

  7. The percentage of patients achieving prednisone-free successfully [ Time Frame: 52 weeks ]
    the percentage of patients achieving prednisone-free successfully

  8. Number of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: 52 weeks ]
    the safety of belimumab


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 years;
  2. 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;
  3. 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.
  4. Sign the informed consent;

Exclusion Criteria:

  1. Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits;
  2. Creatinine clearance rate < 60ml/min;
  3. Exposure to cyclophosphamide within past 6 months before screening;
  4. Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
  5. History of Malignancy;
  6. History of herpes zoster with past 3 months before screening.
  7. Chronic HBV/HCV hepatitis；
  8. Current infections (HIV/tuberculosis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515719


Contacts
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Contact: Fangfang Sun 86-021-34506393 fiona_rj@163.com

Locations
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China, Shanghai
Shuang Ye, MD Recruiting
Shanghai, Shanghai, China
Contact: Shuang Ye, MD    +8613817615871    ye_shuang2000@163.com   
Contact: Huijing Wang, postgraduate    +8618267851823    whj30813@163.com   
Sponsors and Collaborators
RenJi Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04515719    
Other Study ID Numbers: Btrial
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
Belimumab
Systemic Lupus Erythematosus
Disease flare
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs