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

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.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

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

Sponsors & Collaborators

• Genzyme, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Belgium
• France
• Netherlands
• Spain

Study Locations