Primary Sjögren's Syndrome MedDRA version: 12.1 Level: LLT Classification code 10059142 Term: Sjoegren's syndrome
Conditions
Interventions
Trade Name: Sandimmun Optoral
Product Name: Sandimmun Optoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Charité Berlin, Department of rheumatology
Charité Berlin, department of rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Body weight 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy of low-dose Cyclosporine A in patients with primary Sjögren’s Syndrome and joint involvement after 16 week treatment period. ;Secondary Objective: Evaluation of safety of low-dose Cyclosporine A in patients with Sjögren’s Syndrome Examination of general well being and improvement of sicca symptoms Influence on disease activity according to ESSDAI Evaluation of joint inflammation using ultrasound technique ;Primary end point(s): Evaluation of efficacy of low-dose Cyclosporine A in patients with primary Sjögren’s Syndrome and joint involvement after 16 week treatment period. Significant improvement of number of swollen and tender joints. | — |
Countries
Germany
Outcome results
None listed