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: EUCTR2022-004331-23-CZ
• Lead Sponsor: Fakultní nemocnice Ostrava

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified