Low Dose Cyclosporin A in Primary Sjögren Syndrome

Charite University, Berlin, Germany30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sjögren´s Syndrome

Interventions

Cyclosporine ADRUG

Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Charite Universitätsklinikum Berlin Campus Mitte

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 16 weeks

Secondary Outcomes

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

Time frame: 28 weeks

Data from ClinicalTrials.gov

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