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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01693393

Acronym

CYPRESS

Enrollment

Registered

2012-09-26

Start date

2010-03-31

Completion date

2014-10-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren´s Syndrome

Keywords

primary Sjogren´s Syndrome, Cyclosporine

Brief 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.

Interventions

DRUGCyclosporine A

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Other

Measure	Time frame
Study the general health changes and improvement of Sicca-symptoms	16 weeks
Documentation of improvement of articular manifestations by ultrasound examination	16 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026