Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA (EMERALD)

NCT02205489 Phase 4 COMPLETED

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.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 4
Status	COMPLETED
Enrolment	58
Start date	2014-10
Completion	2016-04

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

• Alemtuzumab GZ402673
• cetirizine
• ranitidine
• methylprednisolone
• methylprednisolone
• aciclovir
• esomeprazole
• ibuprofen
• paracetamol

Primary outcomes

• Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion. — up to 30 days in the first treatment course and the second treatment course, respectively
• Proportion of IARs — up to 30 days in the first treatment course and the second treatment course, respectively
• Proportion and type of serious IARs — up to 30 days in the first treatment course and the second treatment course, respectively
• Proportion by type (as defined by clinical symptoms) — up to 30 days in the first treatment course and the second treatment course, respectively

Countries

Belgium, France, Netherlands, Spain