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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Alemtuzumab GZ402673
* Drug: cetirizine
* Drug: ranitidine
* Drug: methylprednisolone
* Drug: methylprednisolone
* Drug: aciclovir
* Drug: esomeprazole
* Drug: ibuprofen
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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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 Patient who has withdrawn consent before enrollment (starting from signed informed consent form).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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GZ402673 LEMTRADA<br>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. | Drug: Alemtuzumab GZ402673<br>* Pharmaceutical form:concentration for solution Route of administration: intravenous infusion<br>* Other names: Lemtrada;Drug: cetirizine<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: ranitidine<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: methylprednisolone<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: methylprednisolone<br>* Pharmaceutical form:solution Route of administration: intravenous<br>Drug: aciclovir<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: esomeprazole<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: ibuprofen<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: paracetamol<br>* Pharmaceutical form:tablet Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| Proportion by type (as defined by clinical symptoms) |  | up to 30 days in the first treatment course and the second treatment course, respectively |