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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.

NCT04633967 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-03-13

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Maritime Neurology

    lead NETWORK

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-15
Primary Completion
2020-12-30
Completion
2021-02-28
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633967 on ClinicalTrials.gov