Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Sclerosis

Not yet recruitingOBSERVATIONAL
Enrollment

600

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

May 31, 2026

Conditions
Multiple Sclerosis
Interventions
DIAGNOSTIC_TEST

Measurement of concentrations of orally-used DMDs

"For effectiveness - the measured concentrations of orally used DMDs will be correlated with the clinical condition of patients with MS (usual clinical examinations such as physical assessment of clinical condition, evaluation of EDSS scale, MSQOL-54 quality of life questionnaire, and routine magnetic resonance imaging of the brain once a year). At the same time, the relationship between the measured concentrations of orally used DMDs and the concentrations of other biomarkers of MS, such as signs of axonal (so-called plasma neurofilament light chain - pNfL) and glial (so-called chitinase 3-like 1 - CHI3L1) damage, will be analyzed. concentrations of selected cytokines, concentrations of CD4 + and CD8 + T-lymphocytes, and the results of a genetic examination of drug transporters, again with an effect on the clinical condition of the patient."

DIAGNOSTIC_TEST

Genetic testing

One blood tube will be taken for genetic testing for the duration of the study, again with standard and routine single injections before taking the drug.

DIAGNOSTIC_TEST

Parameters for routine use of DMDs

"For safety - the usual parameters for routine use of DMDs will be monitored (blood count, liver tests, renal function, etc. according to the specifics of individual drugs)."

OTHER

Side effects of orally used DMDs

"For tolerability - possible side effects of orally used DMDs will be monitored and the effect of genetic testing of drug transporters will be analyzed."

Trial Locations (2)

70300

University of Ostrava, Ostrava

70852

University Hospital Ostrava, Ostrava

All Listed Sponsors
collaborator

University of Ostrava

OTHER

lead

University Hospital Ostrava

OTHER

NCT05112484 - Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Sclerosis | Biotech Hunter | Biotech Hunter