Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 August 2016 |
Main ID: |
EUCTR2014-000092-62-BE |
Date of registration:
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10/06/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Management of the infusion-associated reactions in RRMS patients treated with Lemtrada
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Scientific title:
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Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD |
Date of first enrolment:
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30/07/2014 |
Target sample size:
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56 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000092-62 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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France
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Netherlands
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Spain
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Switzerland
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Contacts
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Name:
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Brigitte De Witte
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Address:
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Airport Plaza - Montreal Building, L. Da Vincilaan 19
1831
Diegem
Belgium |
Telephone:
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+32(0)2 710 54 00 |
Email:
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contact.us@sanofi.com |
Affiliation:
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Sanofi Belgium |
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Name:
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Brigitte De Witte
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Address:
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Airport Plaza - Montreal Building, L. Da Vincilaan 19
1831
Diegem
Belgium |
Telephone:
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+32(0)2 710 54 00 |
Email:
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contact.us@sanofi.com |
Affiliation:
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Sanofi Belgium |
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Key inclusion & exclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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-HumanChorionicGonadotropin blood test), breast feeding
- Known infection with latent tuberculosis or active Tuberculosis
- Known infection with Hepatitis B, Hepatitis C
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsing-remitting multiple sclerosis MedDRA version: 18.1
Level: PT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: alemtuzumab CAS Number: 216503-57-0 Current Sponsor code: GZ402673 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: up to 30 days in the first treatment course and the second treatment course, respectively
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Main 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
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Primary end point(s): Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occuring 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)
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Secondary Objective:
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Source(s) of Monetary Support
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Genzyme Corporation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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