2024-510904-36-00招募中2 期
Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome; RepurpSS-II study
Universitair Medisch Centrum Utrecht1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年6月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The change in ESSDAI upon treatment with LEF/HCQ in pSS patients from baseline to 24 weeks, as compared to treatment with placebo-LEF and placebo-HCQ.
研究概览
简要总结
To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized clinical trial at 24 weeks, followed by a single-arm crossover and an open extension (total duration of 48 weeks) and to evaluate the capacity of molecular fingerprints in prediction of therapy response
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Women and men, aged 18-75 years
- •pSS diagnosed according to the ACR-EULAR 2016 Criteria for pSS
- •Use of a reliable method of contraception
- •Signed written informed consent
排除标准
- •Since LEF has teratogenic effects patients who are pregnant or who are wishing to conceive (also men with a female partner of childbearing age) during or within two years after the study are excluded. During the screenings visit, pregnancy will be excluded in all female patients of childbearing age. The use of reliable contraceptives for the duration of the study up to 2 years after the last study visit is mandatory for all patients (with a partner) of childbearing age.
- •Concomitant heart- and inflammatory bowel disease
- •Patients suffering from sarcoidosis
- •Usage of HCQ or LEF <6 months prior to inclusion
- •Usage of conventional and biological DMARDs and dose escalation non-steroidal inflammatory drugs with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (≤7.5 mg) of oral corticosteroids
- •Inadequate mastery of the Dutch language
- •Patients that breastfeed.
- •Patients with therapy resistant hypertension are excluded since this might be aggravated by LEF
- •In case of maculopathy or retinitis pigmentosa the patient will be excluded from participation. Examination by an ophtalmologist will take place on indication.
- •Patients with secondary Sjögren’s Syndrome (Sjögren’s syndrome associated with other connective tissue disease)
- •Patients with hepatic or renal impairment
- •Patients with a severe infection (including hepatitis B,C or HIV)
- •Presence of a malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma)
- •Significant cytopenia
结局指标
主要结局
The change in ESSDAI upon treatment with LEF/HCQ in pSS patients from baseline to 24 weeks, as compared to treatment with placebo-LEF and placebo-HCQ.
The change in ESSDAI upon treatment with LEF/HCQ in pSS patients from baseline to 24 weeks, as compared to treatment with placebo-LEF and placebo-HCQ.
次要结局
- The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in dryness as measured by unstimulated whole unstimulated and stimulated saliva output in pSS patients.
- The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in EULAR Sjögren’s Syndrome Patient Reported Index or ESSPRI (disease activity from patient’s perspective)
- The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in Lachrymal flow measured by Shirmer’s test, Ocular Staining Score and Tear breakup time.
- The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in tender joint count and swollen joint count (68/66).
研究者
dr. H. Leavis
Scientific
Universitair Medisch Centrum Utrecht
研究点 (1)
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