Aggressive Onset Multiple Sclerosis: A… | Clinical Trial

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

0 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medical College

New York, 10021, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Genzyme, a Sanofi Company

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Nov 26, 2014
Registry last updated: May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed