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: | 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:
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 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 ]
| 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) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
| 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 |
| 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:
|
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 September 27, 2016