Low Dose Cyclosporin A in Primary Sjögren Syndrome
- Registration Number
- NCT01693393
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome
- Detailed Description
NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren Syndrome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Diagnosis of a primary Sjögren´s Syndrome
- Liver values above 1,5 ULN
- uncontrolled arterial hypertension
- intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
- begin with Study medication
Exclusion Criteria
- pre-treatment with Cyclosporine A
- Infection
- Neoplasia
- relevant cardiac, pulmonary, neurologic or psychiatric disease
- life-Vaccination within 4 weeks before begin with study medication
- pregnant or breast-feeding
- weight under 45kg or more than 110kg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclosporine A Cyclosporine A All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks
- Primary Outcome Measures
Name Time Method Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks. 16 weeks
- Secondary Outcome Measures
Name Time Method Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome 28 weeks
Trial Locations
- Locations (1)
Charite Universitätsklinikum Berlin Campus Mitte
🇩🇪Berlin, Germany