Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)

Charité University Medicine Berlin

Status and phase: Completed; Phase 2

Conditions: Sjögren´s Syndrome

Treatments: Drug: Cyclosporine A

Study type: Interventional

Funder types: Other

Identifiers

NCT01693393

COLO400BDE02T

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cyclosporine A

Other group

Description:

All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks

Treatment:

Drug: Cyclosporine A