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

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.
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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.
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Biological: Placebo
Placebo intravenously |
- Percentage of patients with disease flares [ Time Frame: 52 weeks ]Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
- Percentage of patients with mild/moderate flares [ Time Frame: 52 weeks ]Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
- Percentage of patients with major flares [ Time Frame: 52 weeks ]Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
- Time to first disease flare [ Time Frame: 52 weeks ]Time to first disease flare
- prednisone dose at each visit [ Time Frame: 52 weeks ]compare the prednisone dose at each visit
- SELENA-SLEDAI score at each visit [ Time Frame: 52 weeks ]compare the disease activity measured by SELENA-SLEDAI score at each visit
- BiLAG score at each visit [ Time Frame: 52 weeks ]compare the disease activity measured by BILAG score at each visit
- The percentage of patients achieving prednisone-free successfully [ Time Frame: 52 weeks ]the percentage of patients achieving prednisone-free successfully
- Number of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: 52 weeks ]the safety of belimumab
- 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.

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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 |
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)

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
Contact: Fangfang Sun | 86-021-34506393 | fiona_rj@163.com |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Belimumab Systemic Lupus Erythematosus Disease flare |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Belimumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |