Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus
NCT ID: NCT05262686
Last Updated: 2022-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
10 participants
INTERVENTIONAL
2022-04-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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belimumab plus low dose IL-2
10mg/kg belimumab was intravenously injected to patients with systemic lupus erythematosus every month for 24 weeks.
Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL-2 was injected once a week for 12 weeks subcutaneously.
Belimumab
Belimumab was intravenously administrated at a dose of 10mg/kg once a month for at least 24 weeks.
Interleukin-2
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
belimumab
10mg/kg belimumab was administrated to patients with systemic lupus erythematosus for at least 24 weeks, intravenously injected every month.
Belimumab
Belimumab was intravenously administrated at a dose of 10mg/kg once a month for at least 24 weeks.
low dose IL-2
The first stage: interleukine-2 was added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh; The second stage: 1 million IU IL-2 was injected once a week for 12 weeks subcutaneously.
Interleukin-2
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Interventions
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Belimumab
Belimumab was intravenously administrated at a dose of 10mg/kg once a month for at least 24 weeks.
Interleukin-2
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
4\. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
* Hydroxychloroquine, 400 mg/day;
* Prednisone, 10 mg/day
Exclusion Criteria
2\. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit) 3. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
4\. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus (EBV), tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
5\. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
6\. Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
7\. Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
8\. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
18 Years
70 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhanguo Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Institute of Rheuamotology and Immunology
Locations
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Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Peking2021SLE
Identifier Type: -
Identifier Source: org_study_id
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