Status:
COMPLETED
A Canadian Study Assessing the Utility of the Treatment Optimization Recommendations in Multiple Sclerosis
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Brief Summary
The Canadian Multiple Sclerosis Working Group (CMSWG) has developed practical recommendations on how neurologists can assess the status of subjects on disease modifying drugs (DMDs) and decide when it...
Detailed Description
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. The neuro...
Eligibility Criteria
Inclusion
- Subjects with duration of RRMS or CIS ≤ 10 yr from onset of symptoms.
- Subjects aged between 18 and 55 years
- Subjects with EDSS score of 0 to ≤ 4.0
- Subjects on consistent therapy with a single DMD (Avonex®, Betaseron®, Copaxone®, Rebif®) for at least 12 months.
- Subjects whose relapse data over the last 12 months was available in the subject's chart
- Subjects whose EDSS data over the last 12 months was available in the subject's chart
- Subjects who were eligible to receive any of the 4 DMDs
- Consecutive subjects were screened until 10 eligible subjects were enrolled (to minimize any selection bias) - Subject was therefore one of 10 consecutive eligible, consenting subjects
- Subjects who had given written informed consent with the understanding that the subject could withdraw consent at any time without prejudice to future medical care
Exclusion
- Subject who was not expected to be followed reliably over the next 12 months
- Subjects with concomitant participation in any other studies involving investigational or marketed products
- Subject wo had previously failed DMD therapy and/or switched between therapies
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT01142583
Start Date
July 1 2006
End Date
August 1 2009
Last Update
March 18 2014
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