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

Multiple Sclerosis Clinical Trial

Official title:

A Retrospective Study On The Management of Multiple Sclerosis (MS) Over The Last 10 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084798
• Other study ID #: EMR 200077-503
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: July 30, 2014
• Start date: August 2008
• Est. completion date: November 2009

Study information

• Verified date: March 2010
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Taiwan	Chang-Gung Memorial Hospital	Taoyuan county

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Duration from first attack to confirmation of MS		Data collected for last 10 years between 1997 and 2007	No
Secondary	Distribution of MS diagnosis criteria and treatment regimens		Data collected for last 10 years between 1997 and 2007	No
Secondary	Annual relapse rate before and after MS treatment		Data collected for last 10 years between 1997 and 2007	No
Secondary	Changes in Expanded Disability Status Scale (EDSS) before and after treatment		Data collected for last 10 years between 1997 and 2007	No
Secondary	Changes in VEP before and after treatment		Data collected for last 10 years between 1997 and 2007	No
Secondary	Association between baseline demographics/disease characteristics and MS		Data collected for last 10 years between 1997 and 2007	No