Monitoring of drugs used in the treatment of multiple sclerosis

The importance of therapeutic monitoring of teriflunomide and fingolimod in the treatment of multiple sclerosis - TERIFIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-004331-23-CZ

Enrollment

150

Registered

2023-01-17

Start date

2023-03-23

Completion date

Unknown

Last updated

2024-11-11

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 Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients diagnosed with MS, taking fingolimod or teriflunomide for at least 6 months 2) men and women older than 18 years 3) signing 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) pediatric patients 2) refusal to sign the Informed Consent to participate in the study, including consent with genetic testing 3) refusal of blood samples performed beyond standard examinations

Design outcomes

Primary

Measure	Time frame
Main Objective: correlation of the measured concentrations of fingolimod (including the fingolimod-phosphate metabolite) and teriflunomide (including the free fraction) with the clinical status of patients with MS;Secondary Objective: - objectification of adherence to fingolimod and teriflunomide treatment - possible introduction of TDM fingolimod and teriflunomide into routine clinical practice;Primary end point(s): 1) correlation of the measured concentrations of fingolimod (including the metabolite fingolimod-phosphate) and teriflunomide (including the free fraction) with the clinical status of patients with MS 2) objectification of adherence to fingolimod and teriflunomide treatment 3) possible introduction of TDM fingolimod and teriflunomide into routine clinical practice;Timepoint(s) of evaluation of this end point: obtaining all the necessary data after completing the study	—

Measure

Time frame

Main Objective: correlation of the measured concentrations of fingolimod (including the fingolimod-phosphate metabolite) and teriflunomide (including the free fraction) with the clinical status of patients with MS;Secondary Objective: - objectification of adherence to fingolimod and teriflunomide treatment - possible introduction of TDM fingolimod and teriflunomide into routine clinical practice;Primary end point(s): 1) correlation of the measured concentrations of fingolimod (including the metabolite fingolimod-phosphate) and teriflunomide (including the free fraction) with the clinical status of patients with MS 2) objectification of adherence to fingolimod and teriflunomide treatment 3) possible introduction of TDM fingolimod and teriflunomide into routine clinical practice;Timepoint(s) of evaluation of this end point: obtaining all the necessary data after completing the study

—

Secondary

Measure	Time frame
Secondary end point(s): 1) analysis of the relationship between the measured concentrations of fingolimod (including the fingolimod-phosphate metabolite) and teriflunomide (including the free fraction) with the concentrations of other MS biomarkers, such as plasma neurofilament light chains (“pNfL”) concentrations, vitamin D concentrations, and immune system cell concentrations, which are associated with MS 2) analysis of the relationship between the measured concentrations of fingolimod (including the metabolite fingolimod-phosphate) and teriflunomide (including the free fraction) with the results of the examination of the genetic polymorphism of the protein inhibitor Zinc Finger MIZ-1 (ZMIZ1) in patients taking fingolimod and the genetic polymorphism of the efflux transporter BCRP (ABCG2) and of the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH) in patients receiving teriflunomide;Timepoint(s) of evaluation of this end point: obtaining all the necessary data after completing the study	—

Measure

Time frame

Secondary end point(s): 1) analysis of the relationship between the measured concentrations of fingolimod (including the fingolimod-phosphate metabolite) and teriflunomide (including the free fraction) with the concentrations of other MS biomarkers, such as plasma neurofilament light chains (“pNfL”) concentrations, vitamin D concentrations, and immune system cell concentrations, which are associated with MS 2) analysis of the relationship between the measured concentrations of fingolimod (including the metabolite fingolimod-phosphate) and teriflunomide (including the free fraction) with the results of the examination of the genetic polymorphism of the protein inhibitor Zinc Finger MIZ-1 (ZMIZ1) in patients taking fingolimod and the genetic polymorphism of the efflux transporter BCRP (ABCG2) and of the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH) in patients receiving teriflunomide;Timepoint(s) of evaluation of this end point: obtaining all the necessary data after completing the study

—

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