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Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)

This study has been completed.
Information provided by (Responsible Party):
Eugen Feist, Charite University, Berlin, Germany Identifier:
First received: September 14, 2012
Last updated: July 27, 2015
Last verified: July 2015
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome

Condition Intervention Phase
Sjögren´s Syndrome
Drug: Cyclosporine A
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome

Resource links provided by NLM:

Further study details as provided by Eugen Feist, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • Study the general health changes and improvement of Sicca-symptoms [ Time Frame: 16 weeks ]
  • Documentation of improvement of articular manifestations by ultrasound examination [ Time Frame: 16 weeks ]

Enrollment: 30
Study Start Date: March 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sandimmun optoral

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01693393

Charite Universitätsklinikum Berlin Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Eugen Feist, Dr. med. Charite University, Berlin, Germany
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eugen Feist, PD. Dr. med. Eugen Feist, Charite University, Berlin, Germany Identifier: NCT01693393     History of Changes
Other Study ID Numbers: COLO400BDE02T
Study First Received: September 14, 2012
Last Updated: July 27, 2015

Keywords provided by Eugen Feist, Charite University, Berlin, Germany:
primary Sjogren´s Syndrome

Additional relevant MeSH terms:
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents processed this record on May 25, 2017