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

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis Read More

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• Patient who has withdrawn consent before enrollment (starting from signed informed consent form).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