Belimumab In Early Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956484
• Other study ID #: LXM-210622
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Biological:
• Belimumab
Belimumab 10 mg/kg

Drug:
• Standard of care
Steroid(=1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Locations

Country	Name	City	State
China	Peking Union Medical College hospital	Beijing	Dongcheng

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	week 24
Secondary	Serologies	Changes in titers of anti-DNA antibody levels	week 12, week 24
Secondary	Complement levels	Changes in measures of C3, C4	week 12, week 24
Secondary	Dynamics of immune cell subsets	T cell and B cell subsets	week 12, week 24
Secondary	Glucocorticoid tapering	A prednisone dose that was decreased= 7.5mg/d	week 12, week 24
Secondary	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	week 12, week 24
Secondary	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	week 12