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

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

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.

Study Overview

• Status: Completed
• Conditions: Relapsing-remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Alemtuzumab GZ402673; Drug: cetirizine; Drug: ranitidine; Drug: methylprednisolone; Drug: methylprednisolone; Drug: aciclovir; Drug: esomeprazole; Drug: ibuprofen; Drug: paracetamol

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Investigational Site Number 056002
  • Brussels, Belgium, 1070
    • Investigational Site Number 056001
• France
  • Dijon, France, 21000
    • Investigational Site Number 250009
  • Lille Cedex, France, 59037
    • Investigational Site Number 250005
  • Lyon Bron, France, 69677
    • Investigational Site Number 250001
  • Nancy, France
    • Investigational Site Number 250006
  • Nantes, France, 44093
    • Investigational Site Number 250010
  • Nimes, France, 30029
    • Investigational Site Number 250007
  • PARIS Cedex 20, France, 75970
    • Investigational Site Number 250008
  • RENNES Cedex 9, France, 35033
    • Investigational Site Number 250004
  • Strasbourg Cedex 2, France, 67098
    • Investigational Site Number 250003
  • Toulouse, France, 31200
    • Investigational Site Number 250002
• Netherlands
  • Breda, Netherlands, 4818CK
    • Investigational Site Number 528001
  • Rotterdam, Netherlands, 3079DZ
    • Investigational Site Number 528002
• Spain
  • Barcelona, Spain, 08035
    • Investigational Site Number 724001
  • Bilbao, Spain, 48013
    • Investigational Site Number 724005
  • Madrid, Spain, 28040
    • Investigational Site Number 724002
  • Málaga, Spain, 29010
    • Investigational Site Number 724006
  • Sevilla, Spain, 41071
    • Investigational Site Number 724003
  • Valencia, Spain, 46009
    • Investigational Site Number 724004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GZ402673 LEMTRADA; 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; Pharmaceutical form:concentration for solution Route of administration: intravenous infusion; Other Names: Lemtrada; Drug: cetirizine; Pharmaceutical form:tablet Route of administration: oral; Drug: ranitidine; Pharmaceutical form:tablet Route of administration: oral; Drug: methylprednisolone; Pharmaceutical form:tablet Route of administration: oral; Drug: methylprednisolone; Pharmaceutical form:solution Route of administration: intravenous; Drug: aciclovir; Pharmaceutical form:tablet Route of administration: oral; Drug: esomeprazole; Pharmaceutical form:tablet Route of administration: oral; Drug: ibuprofen; Pharmaceutical form:tablet Route of administration: oral; Drug: paracetamol; Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Immunological; Anti-Ulcer Agents; Proton Pump Inhibitors; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H2 Antagonists; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Cetirizine; Ibuprofen; Ranitidine; Esomeprazole; Alemtuzumab; Acyclovir
• Other Study ID Numbers: LPS13650; 2014-000092-62; U1111-1153-3922 (Other Identifier: UTN)