Low Dose Cyclosporin A in Primary Sjögren Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

NCT04597762

Dry Eye Syndromes

COMPLETED NA

Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye

NCT05605314

Dry Eye

RECRUITING

Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom

NCT07171710

Dry Eye Disease

ENROLLING_BY_INVITATION NA

Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

NCT01488396

Stevens-Johnson Syndrome

COMPLETED PHASE4

A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome

NCT02011776

Dry Eye Syndromes Sjögren Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sjögren´s Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cyclosporine A

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

Group Type OTHER

Cyclosporine A

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclosporine A

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sandimmun optoral

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No