Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT01641120
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2012-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessing Tolerability of Avonex Intramuscular Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LTuttle@stfranciscare.org', 'phone': '860-714-2149', 'title': 'Lindsay Tuttle, MPH', 'organization': 'Mandell Center for Multiple Sclerosis, Mount Sinai Rehabilitation Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '25 Gauge', 'description': 'The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '30 Gauge', 'description': 'Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Patient Visual Analog Scale Score for Pre-injection Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '25 Gauge', 'description': 'Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.'}, {'id': 'OG001', 'title': '30 Gauge', 'description': 'Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '2.22', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon Signed Ranks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fear of Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '25 Gauge', 'description': 'Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.'}, {'id': 'OG001', 'title': '30 Gauge', 'description': 'Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '0.509', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.558', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon Signed Ranks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale Score for Post-injection Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '25 Gauge', 'description': 'Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.'}, {'id': 'OG001', 'title': '30 Gauge', 'description': 'Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.201', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.764', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon Signed Ranks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perception of Needle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '25 Gauge', 'description': 'Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.'}, {'id': 'OG001', 'title': '30 Gauge', 'description': 'Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'spread': '0.914', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.853', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.005', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon Signed Ranks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).\n\nA total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '25 Gauge or 30 Gauge Needle', 'description': 'Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.'}], 'periods': [{'title': '25 Gauge Needle Weeks 1, 4, 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '30 Gauge Needle Weeks 2 and 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '10.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-18', 'studyFirstSubmitDate': '2012-07-06', 'resultsFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-18', 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Visual Analog Scale Score for Pre-injection Anxiety', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.'}, {'measure': 'Visual Analog Scale Score for Post-injection Pain', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.'}], 'secondaryOutcomes': [{'measure': 'Fear of Injection', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle.'}, {'measure': 'Perception of Needle', 'timeFrame': 'Weeks 2, 3, 4, 5', 'description': 'Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).\n\nA total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.\n\nData from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.\n\nData from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Intramuscular Injections', 'Relapsing Remitting'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 - 65 years of age;\n* Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;\n* Currently being treated with Avonex® for at least 90 days;\n* Using 25 gauge needles for injection of Avonex® for at least 90 days;\n* Willing and able to complete study questionnaires; and\n* Provided informed consent to participate in this study\n\nExclusion Criteria:\n\n* Diagnosis of Progressive Multiple Sclerosis;\n* History of recent illness or infection;\n* History of allergic reaction to Avonex®;\n* Any prior usage of a 30 gauge needle for administration of Avonex®;\n* Concurrent treatment with other immunomodulating therapies;\n* Pregnant or planning on becoming pregnant;\n* Nursing mothers; and\n* Unable to complete the requirements of the study'}, 'identificationModule': {'nctId': 'NCT01641120', 'briefTitle': 'Assessing Tolerability of Avonex Intramuscular Injections', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle', 'orgStudyIdInfo': {'id': '11-12-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 gauge', 'description': 'Subjects used a 30 gauge needle for intramuscular injection of Avonex.', 'interventionNames': ['Drug: Avonex']}, {'type': 'EXPERIMENTAL', 'label': '25 gauge', 'description': 'Subjects used a 25 gauge needle for intramuscular injection of Avonex.', 'interventionNames': ['Drug: Avonex']}], 'interventions': [{'name': 'Avonex', 'type': 'DRUG', 'otherNames': ['Interferon beta-1a'], 'description': 'Intramuscular injection administered using 25 gauge or 30 gauge needle', 'armGroupLabels': ['25 gauge', '30 gauge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06112', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Mandell Center for Multiple Sclerosis', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Peter B Wade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mandell Center for Multiple Sclerosis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}