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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01084798
First received: March 10, 2010
Last updated: July 30, 2014
Last verified: March 2010

March 10, 2010
July 30, 2014
August 2008
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01084798 on ClinicalTrials.gov Archive Site
  • Duration from first attack to confirmation of MS [ Time Frame: Data collected for last 10 years between 1997 and 2007 ] [ Designated as safety issue: No ]
  • Distribution of MS diagnosis criteria and treatment regimens [ Time Frame: Data collected for last 10 years between 1997 and 2007 ] [ Designated as safety issue: No ]
  • Annual relapse rate before and after MS treatment [ Time Frame: Data collected for last 10 years between 1997 and 2007 ] [ Designated as safety issue: No ]
  • Changes in Expanded Disability Status Scale (EDSS) before and after treatment [ Time Frame: Data collected for last 10 years between 1997 and 2007 ] [ Designated as safety issue: No ]
  • Changes in VEP before and after treatment [ Time Frame: Data collected for last 10 years between 1997 and 2007 ] [ Designated as safety issue: No ]
  • Association between baseline demographics/disease characteristics and MS [ Time Frame: Data collected for last 10 years between 1997 and 2007 ] [ Designated as safety issue: No ]
Same as current
Not Provided
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A Retrospective Study to Understand the Clinical Management of Subjects With Multiple Sclerosis at a Site in Taiwan Over the Last 10 Years
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.

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
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Subjects diagnosed with MS between 1997 and 2007 in Taiwan

Multiple Sclerosis
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
November 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01084798
EMR 200077-503
No
Dr. Yu-Li Wu, Attending Physician, Chang-Gung Memorial Hospital
Merck KGaA
Not Provided
Not Provided
Merck KGaA
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP