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NCT Number: NCT01084798

A Retrospective Study to Understand the Clinical Management of Subjects With Multiple Sclerosis at a Site in Taiwan 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sclerosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang-Gung Memorial Hospital

Taoyuan County, 333, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration from first attack to confirmation of MS

    Time frame: Data collected for last 10 years between 1997 and 2007

  2. Distribution of MS diagnosis criteria and treatment regimens

    Time frame: Data collected for last 10 years between 1997 and 2007

  3. Annual relapse rate before and after MS treatment

    Time frame: Data collected for last 10 years between 1997 and 2007

  4. Changes in Expanded Disability Status Scale (EDSS) before and after treatment

    Time frame: Data collected for last 10 years between 1997 and 2007

  5. Changes in VEP before and after treatment

    Time frame: Data collected for last 10 years between 1997 and 2007

  6. Association between baseline demographics/disease characteristics and MS

    Time frame: Data collected for last 10 years between 1997 and 2007

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Mar 11, 2010
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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