Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-31 @ 11:17 PM
Study NCT ID:
NCT05735067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA", 'timeFrame': 'Patients were treated with INF B 1a for at least 6 months', 'description': 'Anti-inflammatory and disease activity biomarkers'}], 'secondaryOutcomes': [{'measure': "Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA", 'timeFrame': 'Patients were treated with INF B 1a for at least 6 months', 'description': 'Anti-inflammatory and disease activity biomarkers'}, {'measure': "Correlation between Expanded Disability Status Scale and patients' response to interferon beta 1a", 'timeFrame': 'Patients were treated with INF B 1a for at least 6 months', 'description': 'Determination disability level (0 - 6), The lowest value means that it is best outcome and the highest value is the worst outcome.'}, {'measure': "Correlation between malondialdehyde levels and patients' response to interferon beta 1a", 'timeFrame': 'Patients were treated with INF B 1a for at least 6 months', 'description': 'oxidative stress biomarkers'}, {'measure': "Correlation between MRI load and Patients' response to interferon beta 1a", 'timeFrame': 'Patients were treated with INF B 1a for at least 6 months', 'description': 'Determination of T2 lesions'}, {'measure': "Correlation between body mass index and patients' response to interferon beta 1 a", 'timeFrame': 'Patients were treated with INF B 1a for at least 6 months', 'description': 'Body weight measurement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis, IFB 1a'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '19446274', 'type': 'BACKGROUND', 'citation': 'Rudick RA, Polman CH. Current approaches to the identification and management of breakthrough disease in patients with multiple sclerosis. Lancet Neurol. 2009 Jun;8(6):545-59. doi: 10.1016/S1474-4422(09)70082-1.'}, {'pmid': '10852536', 'type': 'BACKGROUND', 'citation': 'Lucchinetti C, Bruck W, Parisi J, Scheithauer B, Rodriguez M, Lassmann H. Heterogeneity of multiple sclerosis lesions: implications for the pathogenesis of demyelination. Ann Neurol. 2000 Jun;47(6):707-17. doi: 10.1002/1531-8249(200006)47:63.0.co;2-q.'}, {'pmid': '20439848', 'type': 'BACKGROUND', 'citation': 'Hesse D, Krakauer M, Lund H, Sondergaard HB, Langkilde A, Ryder LP, Sorensen PS, Sellebjerg F. Breakthrough disease during interferon-[beta] therapy in MS: No signs of impaired biologic response. Neurology. 2010 May 4;74(18):1455-62. doi: 10.1212/WNL.0b013e3181dc1a94.'}, {'pmid': '21530402', 'type': 'BACKGROUND', 'citation': 'Axtell RC, Raman C, Steinman L. Interferon-beta exacerbates Th17-mediated inflammatory disease. Trends Immunol. 2011 Jun;32(6):272-7. doi: 10.1016/j.it.2011.03.008. Epub 2011 Apr 29.'}, {'pmid': '19933767', 'type': 'BACKGROUND', 'citation': 'Brucklacher-Waldert V, Stuerner K, Kolster M, Wolthausen J, Tolosa E. Phenotypical and functional characterization of T helper 17 cells in multiple sclerosis. Brain. 2009 Dec;132(Pt 12):3329-41. doi: 10.1093/brain/awp289.'}]}, 'descriptionModule': {'briefSummary': 'Our study aimed to investigate the effect of interferon beta 1a on the clinical and immunological parameters in Egyptian relapse-remitting multiple sclerosis patients', 'detailedDescription': 'Until recently, relapsing-remitting multiple sclerosis (RRMS) was considered a homogeneous form of multiple sclerosis (MS). Variability both in the immunopathology of active demyelinating lesions in MS and in response to immunomodulatory treatments has demonstrated that RRMS is a heterogeneous form of MS. An overwhelming number of trials have supported the use of interferon-β (IFN-β) as a first-line immunomodulatory treatment in RRMS. Approximately 30% of IFN-β treated RRMS patients are non-responders (NR) to treatment. Despite vast clinical experience in the use of IFN-β, its mechanisms of action have not been fully clarified. Interleukin-17 (IL-17) is a proinflammatory cytokine that is secreted by a lineage of T cells named Th17 cells. The Th17 chemokine pathways are essential for the development of central nervous system (CNS) autoimmune diseases such as MS. A high IL-17 concentration in the serum. of people with RRMS is associated with nonresponse to IFN-β therapy. Some animal and human studies have shown that IFN-β inhibits the activity of Th17 cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian Relapsing-Remitting Multiple Sclerosis Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 50 years at time of signing informed consent form.\n* Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria.\n* Kurtzke EDSS step 0.0 - 6.0.\n* At the time of screening, being treated with a stable dose of Interferon Beta 1a for at least 6 months.\n\nExclusion Criteria:\n\n* they had been treated in the last 30 days with methylprednisolone\n* they had changed their IFN-β preparation within the last 18 months\n* they had other chronic diseases associated with MS\n* they had been previously treated with immunosuppressive agents'}, 'identificationModule': {'nctId': 'NCT05735067', 'briefTitle': 'The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'German University in Cairo'}, 'officialTitle': 'The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': 'MSINF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'RRMS patients who received Interferon beta 1a and have normal weight', 'interventionNames': ['Other: Blood sample collection']}, {'label': 'Group 2', 'description': 'RRMS patients who received Interferon beta 1a and have are obese', 'interventionNames': ['Other: Blood sample collection']}], 'interventions': [{'name': 'Blood sample collection', 'type': 'OTHER', 'description': '5 ml of blood samples were withdrawn from RRMS patients', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1053', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Nasser Institute for Research and Treatment', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German University in Cairo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant in Clinical Pharmacology and Pharmacogenomics Research Gruop', 'investigatorFullName': 'Mohamed Youssef Elsayed', 'investigatorAffiliation': 'German University in Cairo'}}}}