Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05304520
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2022-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for Tysabri Participant Preference
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': 'D000069442', 'term': 'Natalizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6', 'timeFrame': 'Month 6', 'description': 'The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".'}, {'measure': 'Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12', 'timeFrame': 'Month 12', 'description': 'The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Positive for Anti-Natalizumab-Antibody', 'timeFrame': 'Baseline, Month 6 and 12'}, {'measure': 'Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody', 'timeFrame': 'Baseline, Month 6 and 12'}, {'measure': 'Annual Relapse Rate', 'timeFrame': 'Baseline, Months 3, 6, 9, and 12', 'description': 'An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. Annual relapse rate is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.'}, {'measure': 'Time to Relapse', 'timeFrame': 'Baseline, Months 3, 6, 9, and 12', 'description': 'An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings.'}, {'measure': 'Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab', 'timeFrame': 'Baseline, Months 3, 6, 9, and 12', 'description': 'Progression is defined as an increase of at least 1.5 points from a baseline Expanded Disability Status Scale (EDSS) score of 0, or at least 1.0 point from a baseline EDSS score \\>0 and ≤5.5 points, or at least 0.5 point from a baseline EDSS score ≥6.0. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is reported. Improvement is defined analogously, and all other cases are considered as stable disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing-Remitting Multiple Sclerosis (RRMS)']}, 'referencesModule': {'references': [{'pmid': '38616781', 'type': 'DERIVED', 'citation': 'Gold R, Schmidt S, Deisenhammer F, Motte J, Richter N, Taipale K, Salmen HC, Bohland C, Schirduan K. Real-world evidence and patient preference for subcutaneous versus intravenous natalizumab in the treatment of relapsing-remitting multiple sclerosis - initial results from the observational SISTER study. Ther Adv Neurol Disord. 2024 Apr 13;17:17562864241241382. doi: 10.1177/17562864241241382. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with RRMS who are receiving or will initiate natalizumab (intravenous or subcutaneous) as standard of care/routine clinical practice will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)\n* In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC\n\nKey Exclusion Criteria:\n\n* Progressive forms of MS\n* Contraindication to natalizumab treatment according to natalizumab SmPC\n* Concomitant treatment with other drugs for treating RRMS\n* Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05304520', 'briefTitle': 'A Study for Tysabri Participant Preference', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World', 'orgStudyIdInfo': {'id': 'DE-TYS-11923'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'On Natalizumab: Switcher IV to SC Cohort', 'description': 'Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.', 'interventionNames': ['Drug: Natalizumab']}, {'label': 'Natalizumab-Naive IV Cohort', 'description': 'Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months', 'interventionNames': ['Drug: Natalizumab']}, {'label': 'Natalizumab-Naive SC Cohort', 'description': 'Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.', 'interventionNames': ['Drug: Natalizumab']}], 'interventions': [{'name': 'Natalizumab', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Natalizumab-Naive IV Cohort', 'Natalizumab-Naive SC Cohort', 'On Natalizumab: Switcher IV to SC Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'country': 'Germany', 'facility': 'Neurozentrum am Königsplatz Augsburg; Dres. Müller und Schmid', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Bad Homburg', 'country': 'Germany', 'facility': 'Praxis Dr. Schöll', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Caritas Krankenhaus Bad Mergentheim', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'city': 'Bamberg', 'country': 'Germany', 'facility': 'Neurologische Praxis Dr. med. Boris-Alexander Kallmann', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'city': 'Berg', 'country': 'Germany', 'facility': 'Marianne-Strauß-Klinik Starnberg', 'geoPoint': {'lat': 49.81417, 'lon': 12.14161}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Neurologie am Mexikoplatz', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Neurologie im Tempelhofer Hafen Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Neurologisches Facharztzentrum Dr. Masri & Kollegen', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'NFZB Neurologisches Facharztzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis für Neurologie/Dr. med. Martin Delf', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Katholisches Klinikum Bochum gGmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bogen', 'country': 'Germany', 'facility': 'Praxis Dres. Kausch/Lippert', 'geoPoint': {'lat': 48.91122, 'lon': 12.68955}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Neurologische Studiengesellschaft Bonn GbR', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Daun', 'country': 'Germany', 'facility': 'MVZ Daun GmbH', 'geoPoint': {'lat': 50.19716, 'lon': 6.82942}}, {'city': 'Dillingen', 'country': 'Germany', 'facility': 'Neurologie Dillingen', 'geoPoint': {'lat': 49.35557, 'lon': 6.72781}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Neurologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Eltville', 'country': 'Germany', 'facility': 'Praxis Dr. Hartmann', 'geoPoint': {'lat': 50.02858, 'lon': 8.11754}}, {'city': 'Erbach im Odenwald', 'country': 'Germany', 'facility': 'Neuro Centrum science GmbH', 'geoPoint': {'lat': 49.66148, 'lon': 8.99402}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen, Neurolische Klinik', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'med.ring GmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Grevenbroich', 'country': 'Germany', 'facility': 'NeuroDot GmbH', 'geoPoint': {'lat': 51.09102, 'lon': 6.5827}}, {'city': 'Hagen', 'country': 'Germany', 'facility': 'GP Dr. med. Wolfgang Klostermann/ Dr. med. Samir Al-Boutros', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Krankenhaus Martha-Maria Halle-Dölau; Klinik für Neurologie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena, Hans-Berger-Klinik für Neurologie', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Lappersdorf', 'country': 'Germany', 'facility': 'Praxis Dr. Fischer', 'geoPoint': {'lat': 49.04694, 'lon': 12.0913}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Neurokomm - Gesellschaft für Studien und Kommunikation', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'NPS Neurologisch Psychiatrische Studiengesellschaft', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Minden', 'country': 'Germany', 'facility': 'GP Neurologie am Preußenmuseum/ Martina Lorenz/ Dr. med. 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