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

NCT02205489 | Completed Phase 4

• 3 other identifiers: LPS136502014-000092-62U1111-1153-3922
• Study Type: interventional
• Target: 58
• Locations: 4 countries
• Sites: 20

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.

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

GZ402673 LEMTRADA

EXPERIMENTAL

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; Drug: cetirizine; Drug: ranitidine; Drug: methylprednisolone; Drug: aciclovir; Drug: esomeprazole; Drug: ibuprofen; Drug: paracetamol

Interventions

Alemtuzumab GZ402673 DRUG

Pharmaceutical form:concentration for solution Route of administration: intravenous infusion

Also known as: Lemtrada

GZ402673 LEMTRADA

cetirizine DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

ranitidine DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

methylprednisolone DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

aciclovir DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

esomeprazole DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

ibuprofen DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

paracetamol DRUG

Pharmaceutical form:tablet Route of administration: oral

GZ402673 LEMTRADA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label.
• Signed written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (20)

Investigational Site Number 056002

Bruges, 8000, Belgium

Location

Investigational Site Number 056001

Brussels, 1070, Belgium

Location

Investigational Site Number 250009

Dijon, 21000, France

Location

Investigational Site Number 250005

Lille, 59037, France

Location

Investigational Site Number 250001

Lyon Bron, 69677, France

Location

Investigational Site Number 250006

Nancy, France

Location

Investigational Site Number 250010

Nantes, 44093, France

Location

Investigational Site Number 250007

Nîmes, 30029, France

Location

Investigational Site Number 250008

Paris, 75970, France

Location

Investigational Site Number 250004

Rennes, 35033, France

Location

Investigational Site Number 250003

Strasbourg, 67098, France

Location

Investigational Site Number 250002

Toulouse, 31200, France

Location

Investigational Site Number 528001

Breda, 4818CK, Netherlands

Location

Investigational Site Number 528002

Rotterdam, 3079DZ, Netherlands

Location

Investigational Site Number 724001

Barcelona, 08035, Spain

Location

Investigational Site Number 724005

Bilbao, 48013, Spain

Location

Investigational Site Number 724002

Madrid, 28040, Spain

Location

Investigational Site Number 724006

Málaga, 29010, Spain

Location

Investigational Site Number 724003

Seville, 41071, Spain

Location

Investigational Site Number 724004

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Alemtuzumab; Cetirizine; Ranitidine; Methylprednisolone; Acyclovir; Esomeprazole; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Furans; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

NL (2); FR (10); BE (2); ES (6)