Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-30 @ 2:54 AM
Study NCT ID:
NCT00913666
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068556', 'term': 'Interferon beta-1a'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-03', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in bioanalytical measures after receiving therapy for 3 to 6 months', 'timeFrame': 'Study duration is 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy Control Subjects (Group 1)\n\n* Must be in general good health.\n* Must not have received interferons in the past.\n\nAll MS Subjects\n\n* Clinical or laboratory-supported diagnosis of relapsing remitting MS (McDonald et al, criteria numbers 1-4).\n* Either on AVONEX® or treatment-naïve.\n* Have an EDSS score between 0.0 and 5.5, inclusive.\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, to other components of the drug formulation.\n* History of intolerance to acetaminophen, ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.\n* History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.\n* History of malignancy.\n* The presence of any significant medical condition or psychiatric illness not due to MS that, in the investigator's opinion, would interfere with therapy\n* History of uncontrolled seizures within the 3 months prior to enrollment.\n* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.\n* Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 8 weeks prior to enrollment.\n* Positive for human immunodeficiency virus (HIV), hepatitis C antibody (HCV) or positive for hepatitis B surface antigen (HbsAg) at screening.\n\nOther inclusion and exclusion criteria apply as per protocol"}, 'identificationModule': {'nctId': 'NCT00913666', 'briefTitle': 'Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects', 'orgStudyIdInfo': {'id': 'C-863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1', 'description': 'Healthy Volunteers'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'MS patients previously naïve to interferon therapy', 'interventionNames': ['Drug: Interferon beta-1a (Avonex)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable)', 'interventionNames': ['Drug: Interferon beta-1a (Avonex)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'MS patients on interferon beta-1a treatment with a history of breakthrough disease.', 'interventionNames': ['Drug: Interferon beta-1a (Avonex)']}], 'interventions': [{'name': 'Interferon beta-1a (Avonex)', 'type': 'DRUG', 'otherNames': ['Avonex'], 'description': '30 mcg by intramuscular injection once a week', 'armGroupLabels': ['Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Biogen-Idec Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Biogen Idec MD', 'oldOrganization': 'Biogen Idec'}}}}