Importance of monitoring of drugs used in the treatment of multiple sclerosis

Phase 1

Conditions: multiple sclerosis
MedDRA version: 21.1Level: LLTClassification code 10064137Term: Progression of multiple sclerosisSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2021-003195-13-CZ

Lead Sponsor: Fakultní nemocnice Ostrava

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1) patients diagnosed with MS, all forms using any of the oral DMDs
2) men and women older than 18 years
3) signature of the Informed Consent to Participate in the Study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) patients in childhood
2) refusal to sign the Informed Consent to Participate in the Study
3) refusal of blood samples taken beyond standard examinations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: correlation of measured concentrations of orally used DMDs” with the clinical condition of patients with MS;Secondary Objective: 1) objectification of adherence to treatment in individual DMDs<br>2) introduction of therapeutic monitoring of DMDs into routine clinical practice<br>;Primary end point(s): 1) correlation of measured concentrations of orally used DMDs” with the clinical condition of patients with MS<br>2) objectification of adherence to treatment in individual DMDs<br>3) introduction of therapeutic monitoring of DMDs into routine clinical practice<br>;Timepoint(s) of evaluation of this end point: 1) non-compliance with the treatment regimen according to the decision of the attending physician<br>2) non-participation in blood samples taken as part of standard examinations<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) analysis of 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, concentrations of selected cytokines, concentrations of CD4 + and CD8 + T-lymphocytes<br>2) analysis of the relationship between the measured concentrations of orally used DMDs” with the results of genetic examination of drug transporters of the P-gp (ABCB1) and BCRP (ABCG2) type<br>;Timepoint(s) of evaluation of this end point: 1) non-compliance with the treatment regimen according to the decision of the attending physician<br>2) non-participation in blood samples taken as part of standard examinations<br>