A Retrospective Study to Understand the Clinical Management of Subjects With Multiple Sclerosis at a Site in Taiwan Over the Last 10 Years

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01084798
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

This is an observational, non comparative, non-randomised, open-label, retrospective, single centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS) as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. The clinical features and annual relapse rate in the first five years after the onset of disease have been compared between conventional and optico-spinal MS in the earlier studies. This study aims to understand the clinical care pathway of MS subjects and facilitate the subject's diagnosis before converting to MS.

Detailed Description

Multiple Sclerosis is a chronic, inflammatory disease of the central nervous system (CNS) and is characterised by areas of demyelination, or plaques in the CNS. The disease is twice as prevalent in women as compared to men and causes considerable disability over time and continues for the lifetime of the subject. Subjects with MS are thought to have a genetic predisposition for the disease, though environmental factors such as geographic location and possibly viral infection also play an important role in the process of development of the disease.

OBJECTIVES

Primary objective:

* To understand the clinical care pathways of MS subjects at the site over the last 10 years in order to raise the medical attention of MS diagnosis

Secondary objective:

* To review the pattern of MS treatment regimens in MS subjects at a particular site between 1997 and 2007

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-12
• Study Completion: 2009-11
• Status Verified: 2010-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Subjects diagnosed with MS as per Poser or McDonald criteria between 1997 and 2007
• EDSS before treatment was available if subject has started the disease modifying drug treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of locations (medical centre, regional hospital, general practitioners) where subjects were treated for the first episode of attack prior to multiple sclerosis diagnosis	Data collected for last 10 years between 1997 and 2007

Secondary Outcome Measures

Name	Time	Method
Changes in VEP before and after treatment	Data collected for last 10 years between 1997 and 2007
Duration from first attack to confirmation of MS	Data collected for last 10 years between 1997 and 2007
Distribution of MS diagnosis criteria and treatment regimens	Data collected for last 10 years between 1997 and 2007
Annual relapse rate before and after MS treatment	Data collected for last 10 years between 1997 and 2007
Changes in Expanded Disability Status Scale (EDSS) before and after treatment	Data collected for last 10 years between 1997 and 2007
Association between baseline demographics/disease characteristics and MS	Data collected for last 10 years between 1997 and 2007

Trial Locations

Locations (1)

Chang-Gung Memorial Hospital; 🇨🇳 Taoyuan county, Taiwan