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.

Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633967
• Other study ID #: KesoKeso21
• Status: Completed
• Start date: May 15, 2016
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2021
• Source: Maritime Neurology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: December 30, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: Patient s treated with Alemtuzumab as per canadian label -

Exclusion Criteria: Contraindication to Alemtuzumab

-

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Maritime Neurology	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Maritime Neurology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of adverse events in Novel versus standard infusion protocol	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.	2016-2020