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.
NCT ID: NCT04633967
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2016-05-15
2021-02-28
Brief Summary
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Detailed Description
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This 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.
All 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Alemtuzumab Injection
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
Premedication with an H1 and H2 blockade (ranitidine or similar, loratadine or similar) for 7 days prior to the infusion.
Premedication with 50 mg of prednisone orally for 5 days before the infusion.
During Infusion Protocol During infusions methylprednisolone is administered in a dosage of 500 mg on every day of the infusion.
Post Infusion Medication
Post-medication with an H1 and H2 blockade (ranitidine or similar, loratadine or similar) for 7 days after the infusion.
Post-medication with 50 mg of prednisone orally for 5 days after the infusion.
Medications to be used PRN throughout the peri-infusion protocol Benadryl, acetaminophen or other analgesics were allowed
Eligibility Criteria
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Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Maritime Neurology
NETWORK
Responsible Party
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Locations
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Maritime Neurology
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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KesoKeso21
Identifier Type: -
Identifier Source: org_study_id
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