Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 8:38 AM
Study NCT ID:
NCT01272128
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2011-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-16', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months', 'timeFrame': 'Baseline and Month 12', 'description': 'Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in EQ-5D VAS at 6, 18 and 24 months', 'timeFrame': 'Baseline and Months 6, 18 and 24', 'description': 'Quality of life will be assessed on a visual analog scale from 0 = worst imaginable health status to 100 = best imaginable health status.'}, {'measure': 'Change from Baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) score', 'timeFrame': 'Baseline and Months 6, 12, 18 and 24', 'description': "The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The scores are generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health."}, {'measure': 'Change from Baseline in EQ-5D Summary Score', 'timeFrame': 'Baseline and Months 6, 12, 18 and 24', 'description': 'The EQ-5D is a self-administered questionnaire consisting of 5 questions pertaining to specific health states (i.e., mobility, self-care, pain/discomfort, usual activities and anxiety/depression), with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 is derived from these five dimensions where a score of 1 indicates the best health state.'}, {'measure': 'Convenience', 'timeFrame': 'Baseline and Months 6, 12, 18 and 24', 'description': 'Convenience will be assessed by a self-administered convenience questionnaire that asks participants about their treatment satisfaction over the past 2 weeks.'}, {'measure': 'Correlation between VAS and MSIS29', 'timeFrame': 'Baseline and Months 6, 12, 18 and 24', 'description': 'The correlation between the EQ-5D visual analog scale and Multiple Sclerosis Impact Scale 29 scores will be assessed using the Spearman correlation coefficient.'}, {'measure': 'Correlation between VAS and Convenience questionnaire', 'timeFrame': 'Baseline and Months 6, 12, 18 and 24', 'description': 'The correlation between the EQ-5D visual analog scale and convenience questionnaire results will be assessed using the Spearman correlation coefficient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the quality of life of intramuscular (IM) Interferon Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) in a clinical practice setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) who meet the criteria for prescription of Interferon Beta-1a IM at up to 20 Belgian institutions may participate into this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Decision to treat with Interferon Beta-1a (IFN beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization\n* Study enrollment must occur prior to 4th weekly administration of IFN beta-1a\n* Able to understand and complete a self-administered questionnaire\n* No contra-indications for IFN beta-1a\n\nKey Exclusion Criteria:\n\n* Subjects with history of hypersensitivity to natural or recombinant IFN beta or to any component\n* Subjects with primary or secondary progressive MS\n* Subjects with current severe depression and/or suicidal ideation\n* Pregnant women\n* Subjects participating in another clinical trial\n* Subjects who do not want to participate in the study\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01272128', 'acronym': 'AVAIL', 'briefTitle': 'Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Prospective Non-interventional Study to Evaluate the Quality of Life in Belgian Patients With CIS or RRMS in Whom Interferon Beta-1a IM Treatment Has Been Initiated', 'orgStudyIdInfo': {'id': 'BE-AVO-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon beta-1a', 'type': 'DRUG', 'otherNames': ['BG9418', 'Avonex Pen', 'Avonex'], 'description': 'Interferon beta-1a will not be provided as a part of this study. Participants will receive Interferon beta-1a as prescribed by their treating physician prior to enrollment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '2020', 'city': 'Middelheim', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Research Site'}, {'zip': '1340', 'city': 'Ottignies', 'state': 'Brabant Wallon', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': '1200', 'city': 'Woluwe', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Research Site'}, {'zip': '9300', 'city': 'Aalst', 'state': 'East Flanders', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '9100', 'city': 'Saint Niklaas', 'state': 'East Flanders', 'country': 'Belgium', 'facility': 'Research Site'}, {'zip': '8700', 'city': 'Tielt', 'state': 'East Flanders', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.99931, 'lon': 3.32707}}, {'zip': '7331', 'city': 'Baudour', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.48296, 'lon': 3.8332}}, {'zip': '6000', 'city': 'Charleroi', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '6042', 'city': 'Charleroi', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '7100', 'city': 'La Louvière', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '7500', 'city': 'Tournai', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}, {'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4800', 'city': 'Verviers', 'state': 'Liège', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'zip': '6800', 'city': 'Libramont', 'state': 'Luxembourg', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 49.91741, 'lon': 5.37318}}, {'zip': '8340', 'city': 'Sijsele', 'state': 'West Flanders', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.20846, 'lon': 3.31714}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}