Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT04633967
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074323', 'term': 'Alemtuzumab'}], '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and type of adverse events in Novel versus standard infusion protocol', 'timeFrame': '2016-2020', 'description': 'This will include Changes In T,BP, R , during infusion, Need for extended observation, additional medication required or Neurological complications within 7 days of infusion , including headache, worsening of MS as measured by EDSS and peri-infusion infections.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To evaluate a Novel infusion protocol in MS patients treated with Alemtuzumab', 'detailedDescription': "This observational study will evaluate and anaylse primary data investigating the effects of a novel peri-infusion regimen in MS patients in a Candian clinical setting infused with Alemtuzumab.\n\nThis observational study has been developed by a Canadian neurologist with the intent to treat MS patients receiving Alemtuzumab in order to mitigate infusion associated reactions (safety) by utilizing an alternative peri-infusion protocol which is a deviation from the recommendation in the Canadian Product Monograph.\n\nAll the patients' recruited for this observational study were informed and consented for this novel peri-infusion regimen and were clinically followed by the neurologist for the two Alemtuzumab infusion cycles and for any subsequent Alemtuzumab infusions for potential mitigation of infusion associated reactions associated with Alemtuzumab."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with MS qualifying for Alemtuzumab therapy', 'eligibilityCriteria': 'Inclusion Criteria: Patient s treated with Alemtuzumab as per canadian label -\n\nExclusion Criteria: Contraindication to Alemtuzumab\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04633967', 'briefTitle': 'Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.', 'organization': {'class': 'NETWORK', 'fullName': 'Maritime Neurology'}, 'officialTitle': 'Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.', 'orgStudyIdInfo': {'id': 'KesoKeso21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alemtuzumab Injection', 'type': 'DRUG', 'description': 'This observational study is collecting clinical data focusing on infusion associated reactions and changes in vital signs in MS patients Novel Infusion protocol: The protocol consisted of the following Pre-infusion Protocol\n\nPremedication with an H1 and H2 blockade (ranitidine or similar, loratadine or similar) for 7 days prior to the infusion.\n\nPremedication with 50 mg of prednisone orally for 5 days before the infusion.\n\nDuring Infusion Protocol During infusions methylprednisolone is administered in a dosage of 500 mg on every day of the infusion.\n\nPost Infusion Medication\n\nPost-medication with an H1 and H2 blockade (ranitidine or similar, loratadine or similar) for 7 days after the infusion.\n\nPost-medication with 50 mg of prednisone orally for 5 days after the infusion.\n\nMedications to be used PRN throughout the peri-infusion protocol Benadryl, acetaminophen or other analgesics were allowed'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3R1V9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Maritime Neurology', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maritime Neurology', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}