Low Dose Cyclosporin A in Primary Sjögren Syndrome

A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome

Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome

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.

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