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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Acetaminophen; Acyclovir; Alemtuzumab; Cetirizine; Esomeprazole; Ibuprofen; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Ranitidine

Criteria

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• Patient who has withdrawn consent before enrollment (starting from signed informed consent form).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.