Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT02598167
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2015-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Percentage of Participants With DMT Administration Schedule Preferences', 'timeFrame': 'Up to 3 months'}, {'measure': 'Percentage of Participants With DMT Route of Administration Preferences', 'timeFrame': 'Up to 3 months'}, {'measure': 'DMT Efficacy Based on Annualized Relapse Rate', 'timeFrame': 'Up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Participants Education Level', 'timeFrame': 'Baseline'}, {'measure': 'Participants Employment Status', 'timeFrame': 'Baseline'}, {'measure': 'Participants RRMS Disease Duration', 'timeFrame': 'Baseline'}, {'measure': 'Number of Relapses of RRMS in Last 2 Years', 'timeFrame': 'Baseline'}, {'measure': 'Duration since Last Relapse of RRMS', 'timeFrame': 'Baseline'}, {'measure': 'Participants Current DMT for RRMS', 'timeFrame': 'Baseline'}, {'measure': 'Number of Previous DMTs Taken Prior to Switch to Current DMT', 'timeFrame': 'Baseline'}, {'measure': 'Expanded Disability Status Scale (EDSS) Score', 'timeFrame': 'Up to 3 months'}, {'measure': 'Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score', 'timeFrame': 'Up to 3 months'}, {'measure': "Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score", 'timeFrame': 'Up to 3 months'}, {'measure': 'Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score', 'timeFrame': 'Up to 3 months'}]}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'descriptionModule': {'briefSummary': "This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged greater than or equal to (\\>/=) 18 years\n* Participants who have a diagnosis of RRMS as documented in their medical records\n* Participants who have been prescribed a DMT for at least 3 months\n* Participants who have an expanded disability status scale (EDSS) score of 1-6 points\n\nExclusion Criteria:\n\n\\- Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study'}, 'identificationModule': {'nctId': 'NCT02598167', 'briefTitle': 'Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Assessing Patients Preferences Towards Disease-modifying Therapeutic Options in Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'ML29715'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RRMS Population', 'description': 'Participants with a diagnosis of RRMS and being prescribed with a DMT for a period of at least 3 months according to standard local clinical practice will be included.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08970', 'city': 'Sant Joan Despí', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla; Servicio de Neurología', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '12004', 'city': 'Castellon', 'state': 'Castellon', 'country': 'Spain', 'facility': 'Hospital General de Castellon; Servicio de Neurología', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '25198', 'city': 'Lleida', 'state': 'Lerida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28500', 'city': 'Arganda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario del Sureste; Servicio de Neurologia', 'geoPoint': {'lat': 40.30076, 'lon': -3.43722}}, {'zip': '28933', 'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Quiron de Madrid; Servicio de Neurologia', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '36312', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'San Cristóbal de La Laguna', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias; Servicio de Neurologia', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar; Servicio de Neurologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14011', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia; Servicio de Neurologia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon; Servicio de Neurologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Jimenez Diaz; Servicio de Neurología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre; Servicio de Neurologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia; Servicio de Neurologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario Dr. Peset; Servicio de Neurologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario La Fe; Unidad de Esclerosis Multiple', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}