Clinical trial NCT02205489: Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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* Patient who has withdrawn consent before enrollment (starting from signed informed consent form).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 (β-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.

Primary outcomes:
measure: 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.
timeFrame: up to 30 days in the first treatment course and the second treatment course, respectively
measure: Proportion of IARs
timeFrame: up to 30 days in the first treatment course and the second treatment course, respectively
measure: Proportion and type of serious IARs
timeFrame: up to 30 days in the first treatment course and the second treatment course, respectively
measure: Proportion by type (as defined by clinical symptoms)
timeFrame: up to 30 days in the first treatment course and the second treatment course, respectively
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Investigational Site Number 056002
city: Brussels
country: Belgium
facility: Investigational Site Number 056001
city: Dijon
country: France
facility: Investigational Site Number 250009
city: Lille Cedex
country: France
facility: Investigational Site Number 250005
city: Lyon Bron
country: France
facility: Investigational Site Number 250001
city: Nancy
country: France
facility: Investigational Site Number 250006
city: Nantes
country: France
facility: Investigational Site Number 250010
city: Nimes
country: France
facility: Investigational Site Number 250007
city: PARIS Cedex 20
country: France
facility: Investigational Site Number 250008
city: RENNES Cedex 9
country: France
facility: Investigational Site Number 250004
city: Strasbourg Cedex 2
country: France
facility: Investigational Site Number 250003
city: Toulouse
country: France
facility: Investigational Site Number 250002
city: Breda
country: Netherlands
facility: Investigational Site Number 528001
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528002
city: Barcelona
country: Spain
facility: Investigational Site Number 724001
city: Bilbao
country: Spain
facility: Investigational Site Number 724005
city: Madrid
country: Spain
facility: Investigational Site Number 724002
city: Málaga
country: Spain
facility: Investigational Site Number 724006
city: Sevilla
country: Spain
facility: Investigational Site Number 724003
city: Valencia
country: Spain
facility: Investigational Site Number 724004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: