Last updated on July 2019

A Prospective, 24-Month Observational Study to Evaluate Patient Reported Outcomes and Safety After LEMTRADA® Treatment In Patients With Relapsing Multiple Sclerosis Switching From A Prior Disease Modifying Therapy


Brief description of study

A Prospective, 24-Month Observational Study to Evaluate Patient Reported Outcomes and Safety After LEMTRADA® Treatment In Patients With Relapsing Multiple Sclerosis Switching From A Prior Disease Modifying Therapy

Detailed Study Description

6.1 PRIMARY

The primary objective of the study is to evaluate treatment satisfaction as the primary Patient-
Reported Outcome (PRO) in patients with relapsing forms of MS (RMS) treated with LEMTRADA in a real life setting using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4.

6.2 SECONDARY

The secondary objectives of the study are as follows:

PRO
To evaluate the effect of LEMTRADA, in a real life setting, on:
  • MS quality of life (QoL)
  • Fatigue in patients who have symptoms of fatigue at Baseline
  • Disability progression
  • Work productivity/ capacity
  • Cognition
Pharmacodynamics
  • To describe lymphocyte repopulation following LEMTRADA treatment in patients previously treated with other Disease Modifying Therapies (DMTs).
Safety
  • The safety of LEMTRADA following prior treatment with (DMTs) in a real world setting will be evaluated in this study.
Prior DMT Subgroups
  • To describe PROs (treatment satisfaction, QoL, fatigue, disability, work productivity, and cognition), lymphocyte repopulation, and safety in patients treated with LEMTRADA by prior DMT use in a real world setting.
The tertiary objectives of the study are as follows:
  • To describe the switching paradigm(s) as per the Investigator’s decision (ie, maximum/minimum washout period; steroid use) when switching RMS patients from a prior DMT to LEMTRADA.
  • To evaluate Caregiver-Reported Outcome Measures (CROM) in a real life setting for caregivers of LEMTRADA-treated patients using the CAREQoL-MS questionnaire.

    Clinical Study Identifier: TX149647

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    Baptist Health Lexington Clinical Research Center

    1740 Nicholasville Road Lexington, KY USA
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