Maritime Neurology
Halifax, Nova Scotia, B3R1V9, Canada
Completed
NCT Number: 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.
To evaluate a Novel infusion protocol in MS patients treated with Alemtuzumab
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient s treated with Alemtuzumab as per canadian label -
Exclusion criteria
Contraindication to Alemtuzumab
-
Treatment and study plan
Alemtuzumab Injection
DrugThis 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
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Maritime Neurology
Network
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2020
- Study completion
- 2021
- First posted
- Nov 18, 2020
- Registry last updated
- Mar 13, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.