Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 11:51 AM
Study NCT ID:
NCT01310166
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2011-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)', 'timeFrame': '6 Months'}, {'measure': 'Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)', 'timeFrame': '6 months'}, {'measure': 'Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)', 'timeFrame': '6 months'}, {'measure': 'Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)', 'timeFrame': '6 months'}, {'measure': 'Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of B-lymphocytes', 'timeFrame': '6 months'}, {'measure': 'Change from baseline of monocytes', 'timeFrame': '6 months'}, {'measure': 'Change from baseline of Natural Killer cells', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'RRMS', 'relapsing-remitting', 'fingolimod', 'biomarkers'], 'conditions': ['Relapsing-remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria\n* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5\n\nExclusion Criteria:\n\n* Patients with a manifestation of MS other than relapsing remitting MS\n* Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome\n* History or presence of malignancy in the last 5 years\n* Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients\n* Diagnosis of macular edema during Screening Phase\n* Patients with active systemic bacterial, viral or fungal infections\n* Negative for varicella-zoster virus IgG antibodies at Screening\n* Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time\n* History of cardiovascular disorder\n* Women of child-baring potential and inadequate contraception\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01310166', 'acronym': 'Biobank', 'briefTitle': 'Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CFTY720DDE01'}, 'secondaryIdInfos': [{'id': '2010-022066-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod', 'interventionNames': ['Drug: Fingolimod']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'armGroupLabels': ['Fingolimod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73760', 'city': 'Ostfildern', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.72704, 'lon': 9.24954}}, {'zip': '24161', 'city': 'Altenholz-Stift', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}, {'zip': '56626', 'city': 'Andernach', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.43109, 'lon': 7.40425}}, {'zip': '29223', 'city': 'Celle', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'zip': '44135', 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