A Phase 4 interventional study of Belimumab and Placebo in Systemic Lupus Erythematosus, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by RenJi Hospital · Phase 4, Interventional, and Prevention
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.
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 334 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Belimumab 2mg/kg intravenously
Also known as: BENLYSTA™
Placebo intravenously
Percentage of patients with disease flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Percentage of patients with mild/moderate flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Percentage of patients with major flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Time to first disease flare
Time to first disease flare
Time frame: 52 weeks
prednisone dose at each visit
compare the prednisone dose at each visit
Time frame: 52 weeks
SELENA-SLEDAI score at each visit
compare the disease activity measured by SELENA-SLEDAI score at each visit
Time frame: 52 weeks
BiLAG score at each visit
compare the disease activity measured by BILAG score at each visit
Time frame: 52 weeks
The percentage of patients achieving prednisone-free successfully
the percentage of patients achieving prednisone-free successfully
Time frame: 52 weeks
Number of participants with adverse events as assessed by CTCAE v4.0
the safety of belimumab
Time frame: 52 weeks
Subgroup analysis
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
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic→
RenJi Hospital