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

Phase 4

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: Alemtuzumab GZ402673; Drug: cetirizine; Drug: ranitidine; Drug: methylprednisolone; Drug: aciclovir; Drug: esomeprazole; Drug: ibuprofen; Drug: paracetamol

• Registration Number: NCT02205489
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-31
• Study Start: 2014-10
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GZ402673 LEMTRADA	ranitidine	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	cetirizine	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	Alemtuzumab GZ402673	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	methylprednisolone	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	esomeprazole	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	aciclovir	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	ibuprofen	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
GZ402673 LEMTRADA	paracetamol	First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
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 by type (as defined by clinical symptoms)	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

Trial Locations

Locations (20)

Investigational Site Number 056001; 🇧🇪 Brussels, Belgium

Investigational Site Number 528001; 🇳🇱 Breda, Netherlands

Investigational Site Number 528002; 🇳🇱 Rotterdam, Netherlands

Investigational Site Number 250002; 🇫🇷 Toulouse, France

Investigational Site Number 724001; 🇪🇸 Barcelona, Spain

Investigational Site Number 724003; 🇪🇸 Sevilla, Spain

Investigational Site Number 250010; 🇫🇷 Nantes, France

Investigational Site Number 250008; 🇫🇷 PARIS Cedex 20, France

Investigational Site Number 724006; 🇪🇸 Málaga, Spain

Investigational Site Number 724004; 🇪🇸 Valencia, Spain

Investigational Site Number 250009; 🇫🇷 Dijon, France

Investigational Site Number 250007; 🇫🇷 Nimes, France

Investigational Site Number 250004; 🇫🇷 RENNES Cedex 9, France

Investigational Site Number 724002; 🇪🇸 Madrid, Spain

Investigational Site Number 724005; 🇪🇸 Bilbao, Spain

Investigational Site Number 056002; 🇧🇪 Brugge, Belgium

Investigational Site Number 250005; 🇫🇷 Lille Cedex, France

Investigational Site Number 250001; 🇫🇷 Lyon Bron, France

Investigational Site Number 250003; 🇫🇷 Strasbourg Cedex 2, France

Investigational Site Number 250006; 🇫🇷 Nancy, France