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Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course

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ClinicalTrials.gov Identifier: NCT02301572
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Chart review.

Condition or disease
Multiple Sclerosis

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

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Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course
Study Start Date : August 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Aggressive onset MS
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)



Primary Outcome Measures :
  1. Disability outcome will be determined based on EDDS. [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with MS.
Criteria

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)

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301572


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Jai Perumal, MD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02301572     History of Changes
Other Study ID Numbers: 0711009544
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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