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

Importance of therapeutic monitoring of orally administered disease-modifying drugs used in the treatment of multiple sclerosis - TDM-MS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003195-13-CZ

Enrollment

800

Registered

2021-06-21

Start date

2021-06-23

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis MedDRA version: 21.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis System Organ Class: 100000004852

Interventions

Trade Name: Aubagio 14MG TBL FLM Product Name: Aubagio 14MG TBL FLM Pharmaceutical Form: Tablet INN or Proposed INN: TERIFLUNOMIDE CAS Number: 108605-62-5 Other descriptive name: teriflunomide Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
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 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 ;Timepoint(s) of evaluation of this end point: 1) non-compliance with the treatment regimen according to the decision of the attending physician 2) non-participation in blood samples taken as part of standard examinations	—

Measure

Time frame

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 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 ;Timepoint(s) of evaluation of this end point: 1) non-compliance with the treatment regimen according to the decision of the attending physician 2) non-participation in blood samples taken as part of standard examinations

—

Countries

Czech Republic

Contacts

Public ContactIvana Kacírová

Fakultní nemocnice Ostrava

ivana.kacirova@fno.cz+420597374391

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026