Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome
研究概览
简要总结
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)).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a primary Sjögren´s Syndrome
- •ESSDAI score ≥ 6
- •Liver values above 1,5 ULN
- •Stable low dose systemic use of Glucocorticoids（<=7.5mg） in the last 4 weeks before begin with Study medication
排除标准
- •Secondary Sjögren's Syndrome
- •Pre-treatment with Cyclosporine A
- •Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimumab, other immunosuppressives
- •Infection
- •Neoplasia
- •Relevant cardiac, pulmonary, neurologic or psychiatric disease
- •Life-Vaccination within 4 weeks before begin with study medication
- •Pregnant or breast-feeding
- •Weight under 45kg or more than 80kg
研究组 & 干预措施
Experimental: hrIL-2 active
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
干预措施: hrIL-2 active (Drug)
Placebo Comparator: hrIL-2 placebo
1 million U doses of placebo s.c. injection
干预措施: hrIL-2 placebo (Drug)
结局指标
主要结局
Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome
时间窗: 24 weeks
次要结局
- Immunological Responses(0,12,24weeks)
研究者
Zhanguo Li
Chief of Department of Rheumatology and Immunology,Peking University People's Hospital
Peking University People's Hospital