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.

Completed

• Conditions: Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis

• Registration Number: NCT04633967
• Lead Sponsor: Maritime Neurology

Brief Summary

To evaluate a Novel infusion protocol in MS patients treated with Alemtuzumab

Detailed Description

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 Timeline

• Study Start: 2016-05-15
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-18
• Primary Completion: 2020-12-30
• Study Completion: 2021-02-28
• Status Verified: 2021-10
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patient s treated with Alemtuzumab as per canadian label -

Exclusion Criteria

Contraindication to Alemtuzumab

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number and type of adverse events in Novel versus standard infusion protocol	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.

Trial Locations

Locations (1)

Maritime Neurology; 🇨🇦 Halifax, Nova Scotia, Canada