The objective of this study is to assess the distribution of infusion associated reactions (IARs) by severity grade when Lemtrada is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The distribution of IARs based on toxicity grade (severity) observed in the
study for both periods of treatment.
An IAR is defined as any adverse event occurring during or within 24 hours of
LEMTRADA infusion. Toxicity grade (severity) of IAR is based on Common
Terminology Criteria for Adverse Events (CTCAE)
The primary objective will be assessed by summarizing:
* Number (%) of IARs
* Number (%) and type of serious IARs
* Number (%) by type (as defined by clinical symptoms)
Secondary outcome
Not applicable.
Background summary
Multiple sclerosis (MS) is a demyelinating disease of the central nervous
system (CNS) that affects approximately 2.5 million people worldwide.
MS represents the leading cause of neurologic disability in young and
middle-aged adults. It isestimated that as many as 80% of all MS patients
present with relapsing remitting MS (RRMS).
LEMTRADA, is a humanized monoclonal antibody administered intravenously that
has been approved in the European Union for the treatment of active RRMS.
Study objective
The objective of this study is to assess the distribution of infusion
associated reactions (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 design
Multicenter, multinational, phase 4 single arm open-label study.
Intervention
Drug: alemtuzumab (GZ402673, Lemtrada); Pharmaceutical form: Concentrate for
solution for infusion; Route of administration: intravenous.
Study burden and risks
Identified risks of LEMTRADA in patients with MS include:
- Autoimmunity (ITP, nephropathies, thyroid disorders)
- Infections
- Infusion-associated reactions (IARs)
Gooimeer 10
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Gooimeer 10
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Listed location countries
Age
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-HumanChorionicGonadotropin blood test), breast feeding
- Known infection with latent tuberculosis or active Tuberculosis
- Known infection with Hepatitis B, Hepatitis C
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000092-62-NL |
| ClinicalTrials.gov | NCT00930553 |
| CCMO | NL49717.060.14 |