A Phase 1/2 interventional study of low-dose interleukin-2 and rapamycin in Sjögren's Syndrome, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Peking University People's Hospital · Phase 1/2, Interventional, and Treatment
The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks.
Drug: low-dose interleukin-2
Rapamycin 0.5ml once per day for 12 weeks.
Drug: rapamycin
One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.
Drug: low-dose interleukin-2 · Drug: rapamycin
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once twice a week, for 12 weeks.
Also known as: Recombinant Human Interleukin-2
Rapamycin 0.5ml was taken orally once per day
Also known as: sirolimus
Proportion of Treg cells in peripheral blood
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
Time frame: week 12
ESSDAI [potential score 0 - 123]
ESSDAI is \[European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index\]. Higher scores mean a worse outcome.
Time frame: week 12
Physician's Global Disease Activity VAS, (potential score 0 - 10)
Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
Time frame: week 12
Patient's Global Disease Activity VAS, (potential score 0 - 80)
Patient's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
Time frame: week 12
Rate of Participants with adverse effects associated with experimental drugs
Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy.
Time frame: week 12
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital