Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT00230204
Status:
UNKNOWN
Last Update Posted:
2006-02-16
First Post:
2005-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2006-02-15', 'studyFirstSubmitDate': '2005-09-29', 'studyFirstSubmitQcDate': '2005-09-29', 'lastUpdatePostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis'}], 'secondaryOutcomes': [{'measure': 'Assess correlation between antibody levels to various infectious agents with clinical disease variables'}]}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Antibodies', 'Serum', 'Infectious agents', 'Immunoglobulin G', 'Immunoglobulin M'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to assess the prevalence of infectious disease seropositivity (toxoplasmosis, rubella, cytomegalovirus \\[CMV\\]), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori in a group of patients presenting with specific autoimmune diseases (rheumatoid arthritis \\[RA\\], undifferentiated connective tissue disorder \\[UCTD\\], Sjogren, antiphospholipid syndrome - APS, vasculitides, systemic lupus erythematosus \\[SLE\\], polymyositis, Hashimoto, multiple sclerosis, primary biliary cirrhosis \\[PBC\\], etc.), using the BioPlex 2200 and complementary EIA kits as compared to matched controls (by age, sex and ethnicity).', 'detailedDescription': 'The purpose of this investigation is to assess the prevalence of infectious disease seropositivity (toxoplasmosis, rubella, cytomegalovirus \\[CMV\\]), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), syphilis, Epstein-Barr virus and H. pylori in a group of patients presenting with specific autoimmune diseases (RA, UCTD, Sjogren, antiphospholipid syndrome - APS, vasculitides, SLE, polymyositis, Hashimoto, multiple sclerosis, PBC, etc.), using the BioPlex 2200 and complementary EIA kits as compared to matched controls (by age, sex and ethnicity).\n\nWe will assess in our Center 100 patients with multiple sclerosis for the antibody profile of different infectious agents. Comparative assessments will be performed with normal matched subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definite multiple sclerosis\n\nExclusion Criteria:\n\n* Intravenous immune globulin (IVIg) treatment'}, 'identificationModule': {'nctId': 'NCT00230204', 'briefTitle': 'Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Antibodies Screening in Multiple Sclerosis as a Part of an International Survey in Autoimmune Diseases.', 'orgStudyIdInfo': {'id': 'SHEBA-05-3868-AA-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Anne Levy', 'role': 'CONTACT', 'email': 'annlevy@sheba.health.gov.il', 'phone': '972-3-5303932'}, {'name': 'Anat Achiron, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Multiple Sclerosis Center, Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Anat Achiron, MD, PhD', 'role': 'CONTACT', 'email': 'achiron@post.tau.ac.il', 'phone': '972-3-5303811'}, {'name': 'Yehuda Shoenfeld, MD', 'role': 'CONTACT', 'email': 'shoenfel@post.tau.ac.il', 'phone': '972-3-5302652'}], 'overallOfficials': [{'name': 'Anat Achiron, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel'}, {'name': 'Yehuda Shoenfeld', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}}}}