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CompletedNCT04956484Updated Jul 8, 2022

Belimumab In Early Systemic Lupus Erythematosus

A Phase 4 interventional study of Belimumab and Standard of care in Lupus Erythematosus, Systemic, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2022, 4 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).

Read the detailed description

This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of care plus Belimumab (at a dose of 10 mg per kilogram of body weight) .

The primary endpoint is the proportion of LLDAS in week 24.

02

Conditions studied

  • Lupus Erythematosus, Systemic

Keywords

  • SLE
  • Belimumab
03

In context

Lupus Erythematosus, Systemic

1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Peking Union Medical College Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria within three months, which is autoantibody-positive (antinuclear antibody titers ≥1:80, anti-double-stranded DNA antibodies, or both)
  • 18-75 years of age
  • body weight 45-80kg
  • Disease duration of SLE ≤ 6months
  • SELENA-2K score ≥6 scores
  • Negative pregnancy test for child-bearing women at screening and baseline
  • Provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
  • Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
  • Abnormal liver function (ALT or AST is 2 times higher than normal)
  • Pregnancy or breastfeeding women;
  • Have a history of malignant tumors;
  • Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)
  • Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV;
  • Previous visual obstruction, monocular dysfunction and cataract;
  • Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics;
  • Active hemorrhage or peptic ulcer;
  • With other concommitant autoimmune disease;
  • Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization.
  • Participated in other drugs clinical trials within 4 weeks.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Belimumab 10 mg/kg plus standard of care

    Standard of care and Belimumab: 10 mg per kilogram of body weight，days 1 (baseline), 15, and 29 and every 28 days thereafter to week 24

    Biological: Belimumab · Drug: Standard of care

Interventions

  • BiologicalBelimumab

    Belimumab 10 mg/kg

    Also known as: BENLYSTA™

  • DrugStandard of care

    Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

06

What researchers measure

Primary outcomes

  1. LLDAS

    Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials

    Time frame: week 24

Secondary outcomes

  1. Serologies

    Changes in titers of anti-DNA antibody levels

    Time frame: week 12, week 24

  2. Complement levels

    Changes in measures of C3, C4

    Time frame: week 12, week 24

  3. Dynamics of immune cell subsets

    T cell and B cell subsets

    Time frame: week 12, week 24

  4. Glucocorticoid tapering

    A prednisone dose that was decreased≤ 7.5mg/d

    Time frame: week 12, week 24

  5. Remission

    a clinical SLEDAI-2K of 0 (disregarding the serology, including anti-dsDNA and complements), Physician Global Assessment \<0.5 (0-3). The patient may be on antimalarials, low-dose glucocorticoids (prednisolone ≤5 mg/day), and/or stable immunosuppressives including biologics

    Time frame: week 12, week 24

  6. LLDAS

    Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials

    Time frame: week 12

07

Study locations

1 site
  • Peking Union Medical College hospital
    Beijing, Dongcheng 100730, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Apr 2022, 7 months.

Of 31 phase 4 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 42. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2021
First posted
Jul 9, 2021
StartActual
Sep 1, 2021
Primary completionActual
Apr 8, 2022
CompletionActual
Apr 8, 2022
Last update
Jul 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04956484
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Jul 9, 2021
Start date
Sep 1, 2021
Primary completion
Apr 8, 2022
Completion
Apr 8, 2022
Last update
Jul 8, 2022

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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