A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis PASS – OBS13434

  • STATUS
    Recruiting
  • sponsor
    Genzyme Corporation, a Sanofi Company
Updated on 24 November 2020
alemtuzumab
multiple sclerosis

Summary

A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis PASS – OBS13434

Description

The proposed study utilizes a prospective, non-interventional, observational cohort study design to evaluate the necessary duration of monitoring following treatment with LEMTRADA and to further inform appropriate monitoring conditions. It will evaluate the long term safety profile, particularly the AESI incidence rates over time in RMS patients, to accomplish the goal of further informing the recommended duration and conditions of monitoring. This study design enables the capture of important characteristics of RMS patients at baseline, and then provides for longitudinal follow-up of patients to capture information on AESI and other important clinical outcomes. The use of real-world observational data will also allow both descriptive and inferential comparative analyses to be performed to evaluate potential associations between risk factors and AESI outcomes, which in clinical trials are not possible due to limitations of a highly selected clinical trial patient population.

There are no medical benefits that can be guaranteed to you for your taking part in this research study. Your willingness to take part, however, may help doctors better understand and/or treat others who have your condition. Information gained from this study may benefit others. No guarantees have been made to you as to the results of this research study.

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave
Clinical Study IdentifierTX150578
Sponsor Genzyme Corporation, a Sanofi Company
Last Modified on24 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 55 yrs and 0 yrs?
Gender: Male or Female
Do you have any of these conditions: Radiologically Isolated Syndrome or Dermatite Atopique modérée ou grave or Multiple Sclerosis?
A patient is eligible for the study if all of the following apply
Diagnosis of RMS, in accordance with the local label
Initiated LEMTRADA treatment for the first-time within 8 weeks of study entry
Able and willing to provide written informed consent for study participation

Exclusion Criteria

Current participation in a clinical study where LEMTRADA is being used as an investigational product
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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