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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— EMERALD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205489
• Other study ID #: LPS13650
• Secondary ID: 2014-000092-62U1
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2014
• Last updated: June 8, 2016
• Start date: October 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (ß-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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Alemtuzumab GZ402673
Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
• cetirizine
Pharmaceutical form:tablet Route of administration: oral
• ranitidine
Pharmaceutical form:tablet Route of administration: oral
• methylprednisolone
Pharmaceutical form:tablet Route of administration: oral
• methylprednisolone
Pharmaceutical form:solution Route of administration: intravenous
• aciclovir
Pharmaceutical form:tablet Route of administration: oral
• esomeprazole
Pharmaceutical form:tablet Route of administration: oral
• ibuprofen
Pharmaceutical form:tablet Route of administration: oral
• paracetamol
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056002	Brugge
Belgium	Investigational Site Number 056001	Brussels
France	Investigational Site Number 250009	Dijon
France	Investigational Site Number 250005	Lille Cedex
France	Investigational Site Number 250001	Lyon Bron
France	Investigational Site Number 250006	Nancy
France	Investigational Site Number 250010	Nantes
France	Investigational Site Number 250007	Nimes
France	Investigational Site Number 250008	PARIS Cedex 20
France	Investigational Site Number 250004	RENNES Cedex 9
France	Investigational Site Number 250003	Strasbourg Cedex 2
France	Investigational Site Number 250002	Toulouse
Netherlands	Investigational Site Number 528001	Breda
Netherlands	Investigational Site Number 528002	Rotterdam
Spain	Investigational Site Number 724001	Barcelona
Spain	Investigational Site Number 724005	Bilbao
Spain	Investigational Site Number 724002	Madrid
Spain	Investigational Site Number 724006	Málaga
Spain	Investigational Site Number 724003	Sevilla
Spain	Investigational Site Number 724004	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Proportion of IARs		up to 30 days in the first treatment course and the second treatment course, respectively	Yes
Primary	Proportion and type of serious IARs		up to 30 days in the first treatment course and the second treatment course, respectively	Yes
Primary	Proportion by type (as defined by clinical symptoms)		up to 30 days in the first treatment course and the second treatment course, respectively	Yes