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Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Eugen Feist, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01693393
First received: September 14, 2012
Last updated: July 27, 2015
Last verified: July 2015
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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: | 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:
Genetics Home Reference related topics:
Sjögren syndrome
MedlinePlus related topics:
Sjogren's Syndrome
Drug Information available for:
Cyclosporine
U.S. FDA Resources
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01693393
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693393
Locations
| Germany | |
| Charite Universitätsklinikum Berlin Campus Mitte | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Eugen Feist, Dr. med. | Charite University, Berlin, Germany |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | July 27, 2015 |
Keywords provided by Eugen Feist, Charite University, Berlin, Germany:
|
primary Sjogren´s Syndrome Cyclosporine |
Additional relevant MeSH terms:
|
Syndrome Sjogren's Syndrome Dry Eye Syndromes Disease Pathologic Processes 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 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on July 21, 2017