Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 4:24 AM
Study NCT ID:
NCT01693393
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2012-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Cyclosporin A in Primary Sjögren Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Study the general health changes and improvement of Sicca-symptoms', 'timeFrame': '16 weeks'}, {'measure': 'Documentation of improvement of articular manifestations by ultrasound examination', 'timeFrame': '16 weeks'}], 'primaryOutcomes': [{'measure': '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.', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '28 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['primary Sjogren´s Syndrome', 'Cyclosporine'], 'conditions': ['Sjögren´s Syndrome']}, 'referencesModule': {'references': [{'pmid': '27470087', 'type': 'DERIVED', 'citation': "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 Sjogren's syndrome. Clin Rheumatol. 2016 Sep;35(9):2203-10. doi: 10.1007/s10067-016-3360-4. Epub 2016 Jul 28."}]}, 'descriptionModule': {'briefSummary': 'Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a primary Sjögren´s Syndrome\n* Liver values above 1,5 ULN\n* uncontrolled arterial hypertension\n* intraarticular or systemic use of Glucocorticoids in the last 4 weeks before\n* begin with Study medication\n\nExclusion Criteria:\n\n* pre-treatment with Cyclosporine A\n* Infection\n* Neoplasia\n* relevant cardiac, pulmonary, neurologic or psychiatric disease\n* life-Vaccination within 4 weeks before begin with study medication\n* pregnant or breast-feeding\n* weight under 45kg or more than 110kg'}, 'identificationModule': {'nctId': 'NCT01693393', 'acronym': 'CYPRESS', 'briefTitle': 'Low Dose Cyclosporin A in Primary Sjögren Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome', 'orgStudyIdInfo': {'id': 'COLO400BDE02T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cyclosporine A', 'description': 'All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks', 'interventionNames': ['Drug: Cyclosporine A']}], 'interventions': [{'name': 'Cyclosporine A', 'type': 'DRUG', 'otherNames': ['Sandimmun optoral'], 'description': 'Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period', 'armGroupLabels': ['Cyclosporine A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charite Universitätsklinikum Berlin Campus Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Eugen Feist, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD. Dr. med. Eugen Feist', 'investigatorFullName': 'Eugen Feist', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}