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.

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

May 15, 2016

Primary Completion Date

December 30, 2020

Study Completion Date

February 28, 2021

Conditions
Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis
Interventions
DRUG

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"

Trial Locations (1)

B3R1V9

Maritime Neurology, Halifax

All Listed Sponsors
lead

Maritime Neurology

NETWORK

NCT04633967 - 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. | Biotech Hunter | Biotech Hunter