Management Of The Infusion-Associated Reactions In RRMS Patients Treat

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

CompletedPhase 4Relapsing MSNCT022054892014-000092-62

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Alemtuzumab

    CAMPATH-1 antigen inhibitor

  • Cetirizine
  • Ranitidine

    Histamine H2 receptor antagonist

  • Methylprednisolone

    Glucocorticoid receptor agonist

  • Acyclovir

    Human herpesvirus 1 DNA polymerase inhibitor

  • Esomeprazole
  • Ibuprofen

    Cyclooxygenase inhibitor

  • Acetaminophen

    Anandamide amidohydrolase inhibitor|Cyclooxygenase inhibitor|Vanilloid receptor opener

What it measured

Main measures

  • 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

    Safety

  • 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

  • Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC).

Who could take part

Relapsing MS · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Oct 2014

    2. Main results due

      Apr 2016

    3. Finished

      Apr 2016

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