Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-27 @ 5:09 PM
Study NCT ID:
NCT02823951
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2016-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D000069462', 'term': 'Dimethyl Fumarate'}], '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'}, {'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 479}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NEDA-2', 'timeFrame': '12 months', 'description': 'Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients.\n\nNo medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached.'}], 'secondaryOutcomes': [{'measure': 'Clinical differences between the two treatment groups', 'timeFrame': '12 months', 'description': 'Comparison of number of relapses between the two treatment groups.'}, {'measure': 'Neurological differences between two treatment groups', 'timeFrame': '12 months', 'description': 'Comparison of number of new lesions and number of enlarging lesions between the two treatment groups. Unit of measurement is number of each lesion type.'}, {'measure': 'Proportion of individuals within each treatment group who discontinued, stratified by reason', 'timeFrame': '12 months', 'description': 'Proportion of individuals within each treatment group who discontinued treatment due\n\n* to tolerability\n* to adverse events\n* to disease activity Unit of measurement is the share of patients who discontinued compared to total patients stratified by reason of discontinuation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Relapsing-remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).\n2. Age between 18 - 55 years at the time of index.\n3. No evidence of prior disease modifying therapy for MS.\n4. Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.\n5. Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.\n6. Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.\n\nExclusion Criteria:\n\n1. Pregnant at any time during the study observation period.\n2. Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).\n3. Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).\n4. Phase III registrational trial patients"}, 'identificationModule': {'nctId': 'NCT02823951', 'acronym': 'PROTRACT', 'briefTitle': 'Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®', 'organization': {'class': 'INDUSTRY', 'fullName': 'IMS HEALTH GmbH & Co. OHG'}, 'officialTitle': 'Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)', 'orgStudyIdInfo': {'id': 'MS200136_0037'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rebif - 1 year MRI cohort', 'description': 'Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months', 'interventionNames': ['Drug: Rebif']}, {'label': 'Rebif - 1 year clinical cohort', 'description': 'Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline', 'interventionNames': ['Drug: Rebif']}, {'label': 'Rebif - early discontinuation cohort - tolerability', 'description': 'Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability', 'interventionNames': ['Drug: Rebif']}, {'label': 'Rebif - early discontinuation cohort - adverse events', 'description': 'Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events', 'interventionNames': ['Drug: Rebif']}, {'label': 'Rebif - early discontinuation cohort - disease activity', 'description': 'Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity', 'interventionNames': ['Drug: Rebif']}, {'label': 'Tecfidera - 1 year MRI cohort', 'description': 'Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months', 'interventionNames': ['Drug: Tecfidera']}, {'label': 'Tecfidera - 1 year clinical cohort', 'description': 'Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline', 'interventionNames': ['Drug: Tecfidera']}, {'label': 'Tecfidera - early discontinuation cohort - tolerability', 'description': 'Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability', 'interventionNames': ['Drug: Tecfidera']}, {'label': 'Tecfidera - early discontinuation cohort - adverse events', 'description': 'Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events', 'interventionNames': ['Drug: Tecfidera']}, {'label': 'Tecfidera - early discontinuation cohort - disease activity', 'description': 'Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity', 'interventionNames': ['Drug: Tecfidera']}], 'interventions': [{'name': 'Rebif', 'type': 'DRUG', 'armGroupLabels': ['Rebif - 1 year MRI cohort', 'Rebif - 1 year clinical cohort', 'Rebif - early discontinuation cohort - adverse events', 'Rebif - early discontinuation cohort - disease activity', 'Rebif - early discontinuation cohort - tolerability']}, {'name': 'Tecfidera', 'type': 'DRUG', 'armGroupLabels': ['Tecfidera - 1 year MRI cohort', 'Tecfidera - 1 year clinical cohort', 'Tecfidera - early discontinuation cohort - adverse events', 'Tecfidera - early discontinuation cohort - disease activity', 'Tecfidera - early discontinuation cohort - tolerability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Neurology Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Savannah Neurology Specialists', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northshore University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Multi-specialty Group d/b/a Illinois Neurological Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'St Elizabeths/ Dragonfly Research', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Clinic of Neurology', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington university', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68588', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo Clinical and Translational research Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Neurological Associates of Long Island', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Onsite Clinical Solutions', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Center for Neurological Disorders', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}, {'zip': '44685', 'city': 'Uniontown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oak Clinic-Multiple Sclerosis', 'geoPoint': {'lat': 40.97506, 'lon': -81.40817}}, {'zip': '97228', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The university of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '24073', 'city': 'Christiansburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Blacksburg Neurology', 'geoPoint': {'lat': 37.12985, 'lon': -80.40894}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '54956', 'city': 'Neenah', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Neuroscience Group', 'geoPoint': {'lat': 44.18582, 'lon': -88.46261}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IMS HEALTH GmbH & Co. OHG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EMD Serono', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}