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Completed

NCT Number: NCT01693393

Low Dose Cyclosporin A in Primary Sjögren Syndrome

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

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Key information

Conditions

Sjögren´s Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite Universitätsklinikum Berlin Campus Mitte

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine A

Drug

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

Other names: Sandimmun optoral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Study the general health changes and improvement of Sicca-symptoms

    Time frame: 16 weeks

  2. Documentation of improvement of articular manifestations by ultrasound examination

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: CYPRESS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2012
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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