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Clinical Trials/DRKS00030403
DRKS00030403
Recruiting
Not Applicable

An observational, non-interventional, multicenter, prospective study to explore the association of MS-related disability worsening and loss of thalamus volume - PENTAGO

jung diagnostics GmbH0 sites600 target enrollmentOctober 13, 2022
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Conditionsrelapsing-remitting multiple sclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
relapsing-remitting multiple sclerosis
Sponsor
jung diagnostics GmbH
Enrollment
600
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 13, 2022
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
jung diagnostics GmbH

Eligibility Criteria

Inclusion Criteria

  • •? MS, as diagnosed by the revised 2017 McDonald criteria
  • •? Exhibiting a relapsing clinical course and history of brain MRI lesions consistent with MS
  • •? Ages 18 to 55 years, inclusive
  • •? Meet one of the following disease activity criteria
  • •a. more than 10 T2 lesions at the time of the first visit OR
  • •b. at least one documented relapse with the last 12 months prior to the first visit OR
  • •c. documented evidence of at least 1 Gd\-enhancing lesion on brain MRI within the last 12 months prior to the first visit OR
  • •d. documented evidence of at least one new or one enlarging T2 lesion within the last 12 months prior to the first visit.
  • •? Either receive or about to receive oral immune therapies as first or second DMT approach, such as teriflunomide, ozanimod, dimethylfumarate, ponesimod, and diroximethylfumarate.
  • •? Either receive or about to receive second line therapies, such as e.g. monoclonal antibodies, but the number of patients receiving monoclonal antibodies should be restricted to 1/3 of the overall study population.

Exclusion Criteria

  • •? Primary or secondary progressive MS at time of enrollment
  • •? Patients who are not eligible to receive MRI

Outcomes

Primary Outcomes

Not specified

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