Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)

July 27, 2015 updated by: Eugen Feist, Charite University, Berlin, Germany

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Universitätsklinikum Berlin Campus Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cyclosporine A
All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks
Drug: Cyclosporine A
Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
Other Names:
  • Sandimmun optoral

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome 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
Time Frame: 28 weeks
28 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Eugen Feist, Dr. med., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLO400BDE02T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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