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

NCT01084798 | Completed

• 1 other identifier: EMR 200077-503
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Expanded Disability Status Scale; Sclerosis

Outcome Measures

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

  Data collected for last 10 years between 1997 and 2007

Secondary Outcomes (6)

• Duration from first attack to confirmation of MS

  Data collected for last 10 years between 1997 and 2007

• Distribution of MS diagnosis criteria and treatment regimens

  Data collected for last 10 years between 1997 and 2007

• Annual relapse rate before and after MS treatment

  Data collected for last 10 years between 1997 and 2007

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

  Data collected for last 10 years between 1997 and 2007

• Changes in VEP before and after treatment

  Data collected for last 10 years between 1997 and 2007

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with MS between 1997 and 2007 in Taiwan

You may qualify if:

• 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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Chang-Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Multiple Sclerosis; Sclerosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2009
• Last Updated: July 31, 2014

Record last verified: 2010-03

Locations

TW (1)