Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
NCT ID: NCT02205489
Last Updated: 2016-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2014-10-31
2016-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Alemtuzumab GZ402673
Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
cetirizine
Pharmaceutical form:tablet Route of administration: oral
ranitidine
Pharmaceutical form:tablet Route of administration: oral
methylprednisolone
Pharmaceutical form:tablet Route of administration: oral
methylprednisolone
Pharmaceutical form:solution Route of administration: intravenous
aciclovir
Pharmaceutical form:tablet Route of administration: oral
esomeprazole
Pharmaceutical form:tablet Route of administration: oral
ibuprofen
Pharmaceutical form:tablet Route of administration: oral
paracetamol
Pharmaceutical form:tablet Route of administration: oral
Interventions
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Alemtuzumab GZ402673
Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
cetirizine
Pharmaceutical form:tablet Route of administration: oral
ranitidine
Pharmaceutical form:tablet Route of administration: oral
methylprednisolone
Pharmaceutical form:tablet Route of administration: oral
methylprednisolone
Pharmaceutical form:solution Route of administration: intravenous
aciclovir
Pharmaceutical form:tablet Route of administration: oral
esomeprazole
Pharmaceutical form:tablet Route of administration: oral
ibuprofen
Pharmaceutical form:tablet Route of administration: oral
paracetamol
Pharmaceutical form:tablet Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 056002
Bruges, , Belgium
Investigational Site Number 056001
Brussels, , Belgium
Investigational Site Number 250009
Dijon, , France
Investigational Site Number 250005
Lille, , France
Investigational Site Number 250001
Lyon Bron, , France
Investigational Site Number 250006
Nancy, , France
Investigational Site Number 250010
Nantes, , France
Investigational Site Number 250007
Nîmes, , France
Investigational Site Number 250008
Paris, , France
Investigational Site Number 250004
Rennes, , France
Investigational Site Number 250003
Strasbourg, , France
Investigational Site Number 250002
Toulouse, , France
Investigational Site Number 528001
Breda, , Netherlands
Investigational Site Number 528002
Rotterdam, , Netherlands
Investigational Site Number 724001
Barcelona, , Spain
Investigational Site Number 724005
Bilbao, , Spain
Investigational Site Number 724002
Madrid, , Spain
Investigational Site Number 724006
Málaga, , Spain
Investigational Site Number 724003
Seville, , Spain
Investigational Site Number 724004
Valencia, , Spain
Countries
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Other Identifiers
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2014-000092-62
Identifier Type: -
Identifier Source: secondary_id
U1111-1153-3922
Identifier Type: OTHER
Identifier Source: secondary_id
LPS13650
Identifier Type: -
Identifier Source: org_study_id
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