Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course
Completed
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02301572
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
Chart review.
- Detailed Description
A chart review will be completed on patients with multiple sclerosis to determine potential early characteristics that might be helpful in defining aggressive onset MS and predicting subsequent disease course and disability
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
- Two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden or
- One relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location)
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Exclusion Criteria
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disability outcome will be determined based on EDDS. at the last visit (average time frame from baseline to last follow up visit expected to be 36 months) Disability outcomes will be determined based on EDDS at last visit. EDSS at last follow up will be compared to EDSS at start of respective therapies and grouped into 3 categories: EDSS improved, EDSS no change and EDSS worsened. Multivariate logistic regression will be used to test individual variables that could potentially influence the outcome, including treatment, age at onset, gender and race.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Weill Cornell Medical College
🇺🇸New York, New York, United States