nd
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
What it measured
Main measures
To describe patients response to fingolimod treatment as Treg/Teffector ratio. The ratio will be evaluated at baseline and at the end of the study (12 months) (also intermediate points will be considered at 1 month, 3 months, 6 months, ) and its relative increase will be evaluated. This procedure admit us to take into account the individual variability and the intermediate scheduled evaluation may
Other measures (1)
To evaluate cognitive functions of patients at the time of starting fingolimod and after 12 months in order to better describe the patient's clinical status and, consequently, the study drug response.
Thinking and memory
Who could take part
Relapsing MS
Inclusion: They will be included in the study patients male or female aged> 18 years, affected from relapsing remitting multiple sclerosis with high disease activity. Patients will be eligible to treatment with fingolimod according to the data sheet of the drug. In summary, they are deemed eligible for treatment with fingolimod patients belonging to one of the following groups: Exclusion: • Patients with HIV (a specific serologic testing for HIV should be conducted prior to initiating treatment with fingolimod).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The study of the immunological profile at baseline and its variation during the early stages of treatment with fingolimod could represent a predictor of clinical response to therapy. In particular, a regulatory pattern of lymphocyte subtypes represented by a higher ratio of regulatory T cells than the effector T cells, may be an optimal response markers during therapy with fingolimod.
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History
Started
Jun 2021
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