Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT02921035
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2016-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Tunisia', 'United Arab Emirates']}, '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': 594}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score', 'timeFrame': 'Month 24', 'description': 'MGLS is a four item self-reported questionnaire to assess medication adherence. It consists of four questions/items evaluating drug intake habits in subjects on chronic therapies with a scoring scheme of "Yes" = 1 (no adherence) and "No" = 0 (adherence). The items are summed to give an overall score, which ranges from 0 to 4 where high adherence=0, medium adherence=1-2 or low adherence=3-4.'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects on Rebif who discontinued the treatment', 'timeFrame': 'up to 24 months'}, {'measure': 'Time to treatment discontinuation', 'timeFrame': 'up to 24 months'}, {'measure': 'Reason for treatment discontinuation', 'timeFrame': 'up to 24 months', 'description': 'The reason for treatment discontinuation will includes: adverse event, lost to follow-up, lack of efficacy, protocol noncompliance, progressive disease, withdrew consent, death, frequency, unrealistic expectations, other'}, {'measure': 'Percentage of relapse-free subjects', 'timeFrame': 'Month 24'}, {'measure': 'Percentage of subjects with expanded disability status scale (EDSS) progression', 'timeFrame': 'Month 24', 'description': "EDSS is used for multiple sclerosis disability assessment. It is a 10 point scale, where 0 indicates normal motor skills, and 10 indicates patient's death. EDSS progression is defined as one point increase sustained for at least three months."}, {'measure': 'Number of subjects with suspected adverse drug reactions (ADRs) related to Rebif treatment and concomitant therapy over the 24 months of the study', 'timeFrame': 'Up to 24 months'}, {'measure': 'Percentage of relapse-free subjects based on MGLS Score', 'timeFrame': 'Up to 24 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsing Multiple Sclerosis', 'Interferon beta-1a', 'Rebif®', 'Morisky Green Levine Medication Adherence Scale'], 'conditions': ['Relapsing Multiple Sclerosis (RMS)']}, 'referencesModule': {'references': [{'pmid': '38090266', 'type': 'DERIVED', 'citation': 'Al-Roughani R, Zakaria M, Cupler EJ, Taha K. Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study. Front Neurol. 2023 Nov 28;14:1257455. doi: 10.3389/fneur.2023.1257455. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200136_0035', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs (DMDs) will be enrolled into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects aged more than or equal to (\\>=) 18 years and less than or equal to (\\<=) 60 years at the time of Rebif introduction\n* Subjects diagnosed with RMS according to the revised McDonald criteria (2010)\n* Treatment naïve or subjects on other DMDs who will switch to Rebif.\n* Subjects will receive 1st Rebif 44 mcg dose after signing informed consent\n* Subjects willing and able to provide signed informed consent.\n\nExclusion Criteria:\n\n* Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information\n* Subjects participating in other clinical studies/trials\n* Any female subject of childbearing potential who is not on contraceptives\n* Subjects refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02921035', 'briefTitle': 'Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)', 'orgStudyIdInfo': {'id': 'MS200136_0035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relapsing Multiple Sclerosis (RMS) group', 'description': 'Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)', 'interventionNames': ['Drug: Rebif (Interferon beta-1a)']}], 'interventions': [{'name': 'Rebif (Interferon beta-1a)', 'type': 'DRUG', 'description': 'Rebif will be administered at a dose of 44 mcg, sc, tiw.', 'armGroupLabels': ['Relapsing Multiple Sclerosis (RMS) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Algiers', 'country': 'Algeria', 'facility': 'Research site', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'city': 'Annaba', 'country': 'Algeria', 'facility': 'Research site', 'geoPoint': {'lat': 36.9, 'lon': 7.76667}}, {'city': 'Blida', 'country': 'Algeria', 'facility': 'Research site', 'geoPoint': {'lat': 36.47004, 'lon': 2.8277}}, {'city': 'Oran', 'country': 'Algeria', 'facility': 'Research site', 'geoPoint': {'lat': 35.69906, 'lon': -0.63588}}, {'city': 'Sétif', 'country': 'Algeria', 'facility': 'Research site', 'geoPoint': {'lat': 36.19112, 'lon': 5.41373}}, {'city': 'Tizi Ouzou', 'country': 'Algeria', 'facility': 'Research site', 'geoPoint': {'lat': 36.71182, 'lon': 4.04591}}, {'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Research site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'city': 'Rosario', 'country': 'Argentina', 'facility': 'Research site', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Research site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Manama', 'country': 'Bahrain', 'facility': 'Research site', 'geoPoint': {'lat': 26.22787, 'lon': 50.58565}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Research site', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Research site', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Research site 1', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Research site 2', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research site 1', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research site 2', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research site 3', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Esztergom', 'country': 'Hungary', 'facility': 'Research site', 'geoPoint': {'lat': 47.7928, 'lon': 18.74148}}, {'city': 'Isfahan', 'country': 'Iran', 'facility': 'Research site', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Research site', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Research 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'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Rybnik', 'country': 'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 50.09713, 'lon': 18.54179}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Dammam', 'country': 'Saudi Arabia', 'facility': 'Research site', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}, {'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Research site', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'city': 'Khober', 'country': 'Saudi Arabia', 'facility': 'Research site'}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Research site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research site 2', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Merck Serono Middle East FZ-LLC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono Middle East FZ LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}