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.

Maritime Neurology

Status: Completed

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

Treatments: Drug: Alemtuzumab Injection

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04633967

KesoKeso21

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: Contraindication to Alemtuzumab