Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04633967
Recruitment Status : Active, not recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Maritime Neurology

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

Condition or disease Intervention/treatment
Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis Drug: Alemtuzumab Injection

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab


Intervention Details:
  • 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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with MS qualifying for Alemtuzumab therapy
Criteria

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

Exclusion Criteria: Contraindication to Alemtuzumab

-


Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Nova Scotia
Maritime Neurology
Halifax, Nova Scotia, Canada, B3R1V9
Sponsors and Collaborators
Maritime Neurology
Layout table for additonal information
Responsible Party: Maritime Neurology
ClinicalTrials.gov Identifier: NCT04633967    
Other Study ID Numbers: KesoKeso21
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents