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Trial record 3 of 75 for:    Sjögren's Syndrome
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Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)

This study is currently recruiting participants.
Verified September 2012 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Eugen Feist, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01693393
First received: September 14, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Study the general health changes and improvement of Sicca-symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Documentation of improvement of articular manifestations by ultrasound examination [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693393

Contacts
Contact: Eugen Feist, Dr. med +49 30 513 450 220 eugen.feist@charite.de
Contact: Claudia Kedor, Dr. +49 30 450 513 020 claudia.kedor@charite.de

Locations
Germany
Charite Universitätsklinikum Berlin Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Eugen Feist, Dr. med     +49 30 450 513 220     eugen.feist@charite.de    
Contact: Claudia Kedor, Dr.     +49 30 450 513 020     claudia.kedor@charite.de    
Principal Investigator: Eugen Feist, Dr. med            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Eugen Feist, Dr. med. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Eugen Feist, PD. Dr. med. Eugen Feist, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01693393     History of Changes
Other Study ID Numbers: COLO400BDE02T
Study First Received: September 14, 2012
Last Updated: September 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Sjogren's Syndrome
Dry Eye Syndromes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013