Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)
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ClinicalTrials.gov Identifier: NCT01693393 |
Recruitment Status
:
Completed
First Posted
: September 26, 2012
Last Update Posted
: July 29, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sjögren´s Syndrome | Drug: Cyclosporine A | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
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
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- 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 ]
- 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 ]
- 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 ]

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693393
Germany | |
Charite Universitätsklinikum Berlin Campus Mitte | |
Berlin, Germany, 10117 |
Principal Investigator: | Eugen Feist, Dr. med. | Charite University, Berlin, Germany |
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 |
First Posted: | September 26, 2012 Key Record Dates |
Last Update Posted: | July 29, 2015 |
Last Verified: | July 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 |