NCT02386566

Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab

A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	natalizumab	As described in the treatment arm

Timeline

• Start date: 2015-03-20
• Primary completion: 2018-01-28
• Completion: 2018-01-28
• First posted: 2015-03-12
• Last updated: 2018-09-13

Locations

7 sites across 1 country: Switzerland