Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab
Status:
Completed
Trial end date:
2018-01-28
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to determine the association between prospectively
measured disability (Expanded Disability Status Scale [EDSS]) with quality of life (Multiple
Sclerosis International Quality of Life Questionnaire [MusiQoL]) at 3-month intervals up to 1
year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The
secondary objectives of this study are as follows: To evaluate the cumulative probability of
sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the
association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function
[FSMC]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19
[MSISQ-19]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]) and neurocognitive
function (Symbol Digit Modalities Test [SDMT]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to
6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the
relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse)
and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of
clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year
after initiation of natalizumab treatment; To describe changes in work impairment (Work
Productivity and Activity Impairment in MS [WPAI-MS]) at 3-months intervals up to 1 year
after initiation of natalizumab treatment; To describe any change in the percentage of
disability pension and occupation after 1 year of natalizumab treatment; To record the
incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse
Reactions (SUSAR) throughout the study