Last updated on July 2019

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


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: TX150578

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