Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 8:40 AM
Study NCT ID:
NCT03091569
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application", 'timeFrame': 'Week 4, week 6, and week 8', 'description': 'Erythema (redness) evaluated at the site of injection by the clinician on a scale of 0 (clear) to 4 (severe)'}, {'measure': 'Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application', 'timeFrame': 'Week 4, week 6, and week 8', 'description': 'Erythema (redness) at the site of injection rated by the participant on a scale of 0 (clear) to 4 (severe)'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application', 'timeFrame': 'Week 4, week 6, and week 8', 'description': 'Severity of local pain and burning assessed by the participant on a scale of 0 (no discomfort) to 10 (maximum discomfort imaginable)'}, {'measure': 'Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application', 'timeFrame': 'Week 4, week 6, and week 8', 'description': 'Adapted MSTQC self-administered questionnaire evaluates the sum of scores for the "injection systems satisfaction" section questions 1-9 and the "side effects" section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicate better outcomes.'}, {'measure': 'Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application', 'timeFrame': 'Week 4, week 6, and week 8', 'description': 'Measured by the physician using a ruler before and 24 hours after the topical application of cream'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to investigate whether topical Vitamin K application reduces the grade of erythema in comparison with a vehicle cream (placebo) through physicians' assessment and participant self-assessment.\n\nThe secondary objectives of this study are to evaluate in this study population: effects of Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing the erythema diameter; and the evaluation of participants' satisfaction related to the injection treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is deemed necessary by the neurologist. Participants switching from other Disease Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at an injection site different from the previous one.\n\nKey Exclusion Criteria:\n\n* Participants with other skin disorders\n* Pregnancy or current breast-feeding\n* Depression and other psychiatric disorders\n* Unwillingness or inability to comply with the requirements of the protocol.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03091569', 'acronym': 'VITALITY', 'briefTitle': 'Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)', 'orgStudyIdInfo': {'id': 'ITA-PEG-15-10859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin K', 'interventionNames': ['Other: Vitamin K Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Placebo Cream']}], 'interventions': [{'name': 'Vitamin K Cream', 'type': 'OTHER', 'otherNames': ['Filloskin K1'], 'description': 'To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.', 'armGroupLabels': ['Vitamin K']}, {'name': 'Placebo Cream', 'type': 'OTHER', 'description': 'To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}