NCT02205489

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Alemtuzumab GZ402673	Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
DRUG	cetirizine	Pharmaceutical form:tablet Route of administration: oral
DRUG	ranitidine	Pharmaceutical form:tablet Route of administration: oral
DRUG	methylprednisolone	Pharmaceutical form:tablet Route of administration: oral
DRUG	methylprednisolone	Pharmaceutical form:solution Route of administration: intravenous
DRUG	aciclovir	Pharmaceutical form:tablet Route of administration: oral
DRUG	esomeprazole	Pharmaceutical form:tablet Route of administration: oral
DRUG	ibuprofen	Pharmaceutical form:tablet Route of administration: oral
DRUG	paracetamol	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-07-31
• Last updated: 2016-06-09

Locations

20 sites across 4 countries: Belgium, France, Netherlands, Spain