Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sjögren´s Syndrome	Drug: Cyclosporine A	Phase 2

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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 ]

Eligibility Criteria

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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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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kedor C, Zernicke J, Hagemann A, Gamboa LM, Callhoff J, Burmester GR, Feist E. A phase II investigator-initiated pilot study with low-dose cyclosporine A for the treatment of articular involvement in primary Sjögren's syndrome. Clin Rheumatol. 2016 Sep;35(9):2203-10. doi: 10.1007/s10067-016-3360-4. Epub 2016 Jul 28.

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
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