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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-remitting Multiple Sclerosis

Intervention: Alemtuzumab GZ402673 (Drug); cetirizine (Drug); ranitidine (Drug); methylprednisolone (Drug); methylprednisolone (Drug); aciclovir (Drug); esomeprazole (Drug); ibuprofen (Drug); paracetamol (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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.

Clinical Details

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

Primary outcome:

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.

Proportion of IARs

Proportion and type of serious IARs

Proportion by type (as defined by clinical symptoms)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Investigational Site Number 056002, Brugge 8000, Belgium

Investigational Site Number 056001, Brussels 1070, Belgium

Investigational Site Number 250009, Dijon 21000, France

Investigational Site Number 250005, Lille Cedex 59037, France

Investigational Site Number 250001, Lyon Bron 69677, France

Investigational Site Number 250006, Nancy, France

Investigational Site Number 250010, Nantes 44093, France

Investigational Site Number 250007, Nimes 30029, France

Investigational Site Number 250008, PARIS Cedex 20 75970, France

Investigational Site Number 250004, RENNES Cedex 9 35033, France

Investigational Site Number 250003, Strasbourg Cedex 2 67098, France

Investigational Site Number 250002, Toulouse 31200, France

Investigational Site Number 528001, Breda 4818CK, Netherlands

Investigational Site Number 528002, Rotterdam 3079DZ, Netherlands

Investigational Site Number 724001, Barcelona 08035, Spain

Investigational Site Number 724005, Bilbao 48013, Spain

Investigational Site Number 724002, Madrid 28040, Spain

Investigational Site Number 724006, Málaga 29010, Spain

Investigational Site Number 724003, Sevilla 41071, Spain

Investigational Site Number 724004, Valencia 46009, Spain

Additional Information

Starting date: October 2014
Last updated: August 4, 2015

Page last updated: August 23, 2015

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