CompletedPhase 2

Low Dose Cyclosporin A in Primary Sjögren Syndrome

Germany30 participantsStarted 2010-03

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 16 weeks

Trial details

NCT IDNCT01693393

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Sjögren´s Syndrome trials