Clinical trial NCT01084798: A Retrospective Study to Understand the Clinical Management of Subjects With Multiple Sclerosis at a Site in Taiwan Over the Last 10 Years
Official title: A Retrospective Study On The Management of Multiple Sclerosis (MS) Over The Last 10 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Expanded Disability Status Scale
Sclerosis
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with MS between 1997 and 2007 in Taiwan

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.

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 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.

Primary outcomes:
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
timeFrame: Data collected for last 10 years between 1997 and 2007
Secondary outcomes:
measure: Duration from first attack to confirmation of MS
timeFrame: Data collected for last 10 years between 1997 and 2007
measure: Distribution of MS diagnosis criteria and treatment regimens
timeFrame: Data collected for last 10 years between 1997 and 2007
measure: Annual relapse rate before and after MS treatment
timeFrame: Data collected for last 10 years between 1997 and 2007
measure: Changes in Expanded Disability Status Scale (EDSS) before and after treatment
timeFrame: Data collected for last 10 years between 1997 and 2007
measure: Changes in VEP before and after treatment
timeFrame: Data collected for last 10 years between 1997 and 2007
measure: Association between baseline demographics/disease characteristics and MS
timeFrame: Data collected for last 10 years between 1997 and 2007
Other outcomes:
Locations:
city: Taoyuan county
country: Taiwan
facility: Chang-Gung Memorial Hospital
Study officials:
References: