Low Dose Cyclosporin A in Primary Sjögren Syndrome

Sjögren´s Syndrome Clinical Trial

— CYPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693393
• Other study ID #: COLO400BDE02T
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2012
• Last updated: July 27, 2015
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren´s Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Charite Universitätsklinikum Berlin Campus Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study the general health changes and improvement of Sicca-symptoms		16 weeks	No
Other	Documentation of improvement of articular manifestations by ultrasound examination		16 weeks	No
Primary	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.		16 weeks	No
Secondary	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		28 weeks	Yes