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

July 30, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan county, Taiwan, 333
        • Chang-Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with MS between 1997 and 2007 in Taiwan

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 200077-503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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