CompletedEarly (CIS/RIS)NCT05815108

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • NO INTERVENTION

What it measured

Main measures

  • Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay

    Retrospectively at baseline (RIS diagnosis)

Other measures (6)

  • Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • Prevalence of EBV seropositivity in RIS patients according to their MRI activity

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

    MRI lesionsImmune response
  • Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

    MRI lesionsImmune response
  • Assessment correlation between antibodies titers and clinical conversion

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

    MRI lesions

Who could take part

Early (CIS/RIS) · 15 to 70

Inclusion Criteria: Patients with RIS confirmed by the RIS expert center of the Nice CHU; EBNA status at RIS diagnosis available Exclusion Criteria: none

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).

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History

    1. Started

      Mar 2023

    2. Main results due

      Mar 2023

    3. Finished

      Mar 2023

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