Optimizing DMARD therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome - LEF/HCQ combination therapy for pSS

niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1) Women and men, 18-75 years
•2) Primary Sjogren's Syndrome diagnosed according to the American-European Consensus Criteria, revised in 2002
•3) Lymphocyte focus score (local lymphocytic infiltrates) *1 in sublablial salivary gland specimen
•4) ESSDAI * 5
•5) Use of a reliable method of contraception
•6) Signed written informed consent

•1) Pregnancy or the wish to conceive (also for men) during the study or within 2 years after the study
•2) Breastfeeding
•3) Therapy resistant hypertension
•4) Maculopathy or retinitis pigmentosa
•5) Secondary Sjogren*s Syndrome
•6) Hepatic or renal impairment
•7) Severe infection (including hepatitis B,C or HIV)
•8) Malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma)
•9) Significant cytopenia
•10) Concomitant heart- and inflammatory bowel disease
•11) Sarcoidosis
•12) Usage of HCQ or LEF <6 months year prior to inclusion
•13) Usage of immunosuppressive drugs, with the exception of a stable dose of non- steroidal inflammatory drugs (NSAID's) and a stable, low dose (*7.5 mg) of oral corticosteroids
•14) Inadequate mastery of the Dutch language;Exclusion criteria for imaging part (MRI and PET/CT)
•1. A history of allergy/hypersensitivity to radio-isotopes or gadolinium-containing contrast agents
•2. A fasting blood glucose level of >11 mmol/L at screening
•3. Standard safety procedures for MRI will be applied, for example patients with metal or internal medical devices within their body will be excluded;Patients that meet any of the exclusion criteria for the imaging part of the study will be excluded only from this part of the study. If that patient does meet criteria for inclusion in the main study, she can still participate to this main part.

发起方

niversitair Medisch Centrum Utrecht