Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-13 @ 11:21 AM
Study NCT ID:
NCT00618267
Status:
COMPLETED
Last Update Posted:
2010-03-05
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay.
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': 'About 1 ½ teaspoons of blood will be drawn.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-04', 'studyFirstSubmitDate': '2008-02-08', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells.', 'timeFrame': '1 blood draw'}], 'secondaryOutcomes': [{'measure': 'Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.', 'timeFrame': '1 blood draw'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if we can find a new way to test how certain Multiple Sclerosis (MS) medications work in the body and to better understand how the medicines change certain substances (cells) found in the immune (protective) system.\n\nBlood test will be drawn by doing the following:\n\n* Use a new method called the "Immuknow®" Test to see if this method will help to better understand how MS medicines work.\n* Measure certain levels of immune cells in a new way, to see if it this will help to understand the body\'s response to MS medicines.\n\nThese methods will test those with MS who are not taking any MS medications, to help us compare the results.\n\nAbout 100 subjects will be enrolled in this study at the Partners Multiple Sclerosis Center at Brigham and Women\'s Hospital. Biogen Idec, Inc. of Cambridge, MA, is paying for this study to be done.', 'detailedDescription': 'The primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells and to determine whether the "ImmuKnow®" assay is an appropriate screening tool to assess the immunocompetence of potential Tysabri patients.\n\nSecondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.\n\nTertiary objective is to examine the level of regulatory T-cells (CD4+ and CD25+) in MS patients and its possible correlation to the therapy used, and how well a recently proposed marker of regulatory T-cells, LAP, correlates with CD25 marker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Multiple Sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be taking 1 of the following medications for 3 months or more: Cytoxan, Cellcept, Novantrone Betaseron, Rebif, Avonex or Copaxone.\n2. Patients must be able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients on combination of multiple medications.\n2. Restricted treatment whereby no use in 50 days prior to enrollment visit is permitted: systemic steroids.\n3. With educational completion below 8th grade school equivalent or non-fluent in English.\n4. Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.'}, 'identificationModule': {'nctId': 'NCT00618267', 'acronym': 'Cylex', 'briefTitle': 'ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Single Center, Pilot Study to Measure ATP Expression in Lymphocytes of MS Patients Undergoing Various Therapies by Means of Using the "ImmuKnow®" Test', 'orgStudyIdInfo': {'id': '014-07-NAT'}, 'secondaryIdInfos': [{'id': 'Biogen Idec 014-07-NAT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital - Partners MS Center", 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}], 'overallOfficials': [{'name': 'Samia J Khoury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Harvard Medical School, Brigham and Women's Hospital - Partners MS Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Biogen Idec, Inc.', 'oldOrganization': 'Biogen Idec, Inc.'}}}}