Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress

Charité Berlin, Department of rheumatology0 个研究点开始时间: 2009年12月7日最近更新: 2012年4月18日

试验速览

暂无简介。

•1. Primary Sjögren's Syndrome according to european-american classification criteria
•2. Joint involvement defined as minimum 3 painfull and/or 3 swollen joints at Screening and Baseline
•3. Stable treatment including NSAID's for a minimum of 4 weeks
•4. Males & females aged 18 - 75 years
•5. Adequate hematologically results defined as Hb = 10 g/dl, Thrombocytes = 100.000/µl und Neutrophils = 2.500/µl
•6. Serum-Creatinin-Koncentration and/ or Creatinin-Clearance in normal range
•7. Female patients of childbearing potential must have a negative pregnancy-test at screening
•8. Males and females of childbearing potential must use a reliable method of contraception
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Body weight < 45 kg and > 110 kg
•2. Intraarticular or systemic treatment with glucocorticoids within 4 weeks before Baseline
•3. Treatment with narcotic analgetics (excluding permitted concomittant medications such as Tramadol and Codein)
•4. Diagnosis of other, severe, chronic-inflammatory diseases
•5. Previous systemic treatment with Cyclosporine A
•6. Uncontrolled hypertension
•7. Significant or uncontrolled concomitant disease
•8. Relevant and active infection
•9. Abnormal liver function test (AP or ALT elevated = 1,5 x upper normal range)
•10. Abnormal Serum-Creatinin-Koncentration and/ or Creatinin-Clearance
•11. History of neoplasm except:
•- curative treated Non-Malign-Skin-Cancer,
•- treated cervical carcinoma in situ,
•- other curative treated neoplasm without evidence of recrudescence
•over 10 years

发起方

Charité Berlin, Department of rheumatology