Text Size

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: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study On The Management of Multiple Sclerosis (MS) Over The Last 10 Years

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 123
Study Start Date: August 2008
Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with MS between 1997 and 2007 in Taiwan

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084798

Locations
Taiwan
Chang-Gung Memorial Hospital
Taoyuan county, Taiwan, 333
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Dr. Yu-Li Wu, Attending Physician, Chang-Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01084798     History of Changes
Other Study ID Numbers: EMR 200077-503
Study First Received: March 10, 2010
Last Updated: March 10, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Merck KGaA:
Multiple sclerosis
Expanded Disability Status Scale
Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013