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

MC Utrecht0 个研究点开始时间: 2015年8月26日最近更新: 2015年10月6日

适应症

试验速览

暂无简介。

•1) women, age 18-75 years
•2) pSS 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) presence of autoantibodies directed to pSS-related SSA and/or SSB nuclear antigens
•6) use of a reliable method of contraception
•7) signed written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1) Pregnancy or the wish to conceive during the study or within 2 years after the study
•2) Breastfeeding
•3) Therapy-resistent 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 cardiac- and inflammatory bowel disease
•11) Sarcoidosis
•12) Usage of LEF of HCQ <6 months prior to inclusion
•13) Usage of immunosuppressive drugs, with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (=7.5 mg) of oral corticosteroids
•14) Inadequate mastery of the Dutch language

发起方

MC Utrecht