Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-04-14 @ 2:10 PM
Study NCT ID:
NCT02323269
Status:
TERMINATED
Last Update Posted:
2016-04-08
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
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': 'D000069462', 'term': 'Dimethyl Fumarate'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'whyStopped': '109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate (ARR) at month 12', 'timeFrame': 'Month 12', 'description': 'Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score', 'timeFrame': 'Baseline and month 12', 'description': "TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction."}, {'measure': 'Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores', 'timeFrame': 'Baseline and month 12', 'description': 'SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.'}, {'measure': 'Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores', 'timeFrame': 'Baseline and month 12', 'description': 'MFIS-5 a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.'}, {'measure': 'Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores', 'timeFrame': 'Baseline and month 12', 'description': 'BDI-7 is is a self-report inventory for measuring the severity of depression on a 7-item scale.'}, {'measure': 'Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores', 'timeFrame': 'Baseline and month 12', 'description': 'WPAI-MS is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Multiple Sclerosis'}, {'measure': 'Change from baseline to Month 12 in the Morisky 8-item Medication Adherence Scale (MMAS-8) scores', 'timeFrame': 'Baseline and month 12', 'description': 'MMAS-8 is a self-reporting tool to facilitate the identification of barriers to and behaviors associated with adherence to chronic medications. Scores on the MMAS-8 range from 0-8, with scores of less than 6 reflecting low adherence.'}, {'measure': 'Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores', 'timeFrame': 'Baseline and month 12', 'description': 'The patient reported EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems.'}, {'measure': 'Proportion of patients relapsing at Month 12', 'timeFrame': 'Month 12', 'description': 'Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.'}, {'measure': 'Proportion of patients with relapses associated with hospitalizations at Month 12', 'timeFrame': 'Month 12'}, {'measure': 'Proportion of patients with relapses associated with steroid use at Month 12', 'timeFrame': 'Month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting', 'Relapsing-Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. The secondary objectives of this study in this study population are: To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be conducted in male and female patients with relapsing-remitting MS who satisfy the therapeutic indication for DMF per the Canadian Product Monograph, and who are either treatment-naïve or responding suboptimally to MS platform therapies (e.g., IFN or GA), as determined by the Prescribing Physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Have access to the internet and are able to complete online assessments on a computer.\n* Have relapsing-remitting MS and satisfy the approved therapeutic indication for DMF per the Canadian Product Monograph.\n* Are either treatment-naïve or being treated for RRMS with IFN or GA but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to IFN or GA or have stopped treatment with IFN or GA for RRMS as a result of suboptimal response within 30-60 days of enrollment.\n\nKey Exclusion Criteria:\n\n* Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.\n* Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)\n* Are receiving disease modifying therapies other than IFN or GA or have initiated treatment with a new disease modifying therapy since discontinuation of IFN or GA.\n\nNOTE: Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02323269', 'acronym': 'IMPROVE', 'briefTitle': 'Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)', 'orgStudyIdInfo': {'id': '109MS415'}, 'secondaryIdInfos': [{'id': 'CAN-BGT-14-10614', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment naive to dimethyl fumarate', 'description': 'Participants who are prescribed dimethyl fumarate as their initial therapy will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily.', 'interventionNames': ['Drug: dimethyl fumarate']}, {'label': 'Switch to dimethyl fumarate', 'description': 'Participants who are prescribed dimethyl fumarate after suboptimal response to IFN or GA will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily.', 'interventionNames': ['Drug: dimethyl fumarate']}], 'interventions': [{'name': 'dimethyl fumarate', 'type': 'DRUG', 'otherNames': ['DMF', 'BG00012', 'Tecfidera'], 'description': 'administered according to the local product label (i.e., Canadian Product Monograph).', 'armGroupLabels': ['Switch to dimethyl fumarate', 'Treatment naive to dimethyl fumarate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2G3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5G 2X6', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 4K4', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B1P 1P3', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'N1R 7L6', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'J9J 0A5', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}