Clinical trial NCT04956484: Belimumab In Early Systemic Lupus Erythematosus
Official title: A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lupus Erythematosus, Systemic
Keywords: SLE
Belimumab
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: LLDAS
timeFrame: week 24
Secondary outcomes:
measure: Serologies
timeFrame: week 12, week 24
measure: Complement levels
timeFrame: week 12, week 24
measure: Dynamics of immune cell subsets
timeFrame: week 12, week 24
measure: Glucocorticoid tapering
timeFrame: week 12, week 24
measure: Remission
timeFrame: week 12, week 24
measure: LLDAS
timeFrame: week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College hospital
state: Dongcheng
Study officials:
References: