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| Name | Class |
|---|---|
| Monash University | OTHER |
| Beijing ShuangLu Pharmaceutical Co., Ltd. | OTHER |
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Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Currently, there is no approved systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
Each pSS patients (n=60) with Scores>=6 on ESSDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety, clinical and immunologic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: hrIL-2 active | Active Comparator | Intervention:Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection |
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| Placebo Comparator: hrIL-2 placebo | Placebo Comparator | 1 million U doses of placebo s.c. injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hrIL-2 active | Drug | 1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Responses | Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study | 0,12,24weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li, MD, PhD | Peking University Institute of Rheumatology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39482484 | Derived | Feng R, Xiao X, Wang Y, Huang B, Chen J, Cheng G, Jin Y. Metabolic impact of low dose IL-2 therapy for primary Sjogren's Syndrome in a double-blind, randomized clinical trial. Clin Rheumatol. 2024 Dec;43(12):3789-3798. doi: 10.1007/s10067-024-07165-2. Epub 2024 Oct 31. | |
| 36355371 | Derived | He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451. |
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| hrIL-2 placebo | Drug | 1 million U doses of placebo s.c. injection active group: placebo group =1:1 |
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