Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA (EMERALD)

Genzyme

Status and phase

Completed

Phase 4

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

Drug: paracetamol

Drug: ibuprofen

Drug: aciclovir

Drug: methylprednisolone

Drug: Alemtuzumab GZ402673

Drug: cetirizine

Drug: esomeprazole

Drug: ranitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02205489

LPS13650

U1111-1153-3922 (Other Identifier)

2014-000092-62

Details and patient eligibility

About

Primary Objective:

To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.

Full description

The total duration of participation in the study per patient is approximately 13.5 months.

After the end of the second course of LEMTRADA treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label.
Signed written informed consent.

Exclusion criteria

Previously treated with LEMTRADA.
Contraindications to LEMTRADA according to the labeling in the country.
Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label.
Currently participating in another investigational interventional study.
Any technical/administrative reason that makes it impossible to enroll the patient in the study.
Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Patient who has withdrawn consent before enrollment (starting from signed informed consent form).
Despite screening of the patient, enrolment is stopped at the study level.
Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.
Pregnancy (defined as positive beta human chorionic gonadotropin (β-HCG) blood test), breast feeding.
Known infection with latent tuberculosis or active tuberculosis.
Known infection with Hepatitis B, Hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

58 participants in 1 patient group

GZ402673 LEMTRADA

Experimental group

Description:

First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.

Treatment: