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.
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|ClinicalTrials.gov Identifier: NCT04633967|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
|Condition or disease||Intervention/treatment|
|Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis||Drug: Alemtuzumab Injection|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official 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.|
|Actual Study Start Date :||May 15, 2016|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||February 28, 2021|
- 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
- Number and type of adverse events in Novel versus standard infusion protocol [ Time Frame: 2016-2020 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633967
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3R1V9|