NCT01693393

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sjögren´s Syndrome

Interventions

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

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-09-26
• Last updated: 2015-07-29

Locations

1 site across 1 country: Germany