Czech Pharmaco-epidemiological Study on Disease Modifying Drugs (CPE)

IMPULS Endowment Fund

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab

Study type: Observational

Funder types: Other

Identifiers

NCT05762003

ML41011

Details and patient eligibility

About

Multiple sclerosis (MS) is a severe autoimmune disease that affects mainly young individuals. It is estimated that there are 17-20,000 affected persons in the Czech Republic.

Currently, MS remains an incurable but treatable disease. As of now, there are many drugs that are able to reduce the inflammatory part of the disease that prevails in its initial phases. The problem is the great variability of the severity of clinical course (from relatively benign to severe malignant courses) and different responses of particular patients to particular drugs. A personalized approach with long life monitoring and adjustment of treatment according to the activity of the disease is essential.

From this point of view registries represent one of the most important source of long term data that is used for evaluation of effectiveness and safety of different drugs in areal life setting.

The objective of this study is to compare effectiveness and safety profile in MS patients treated with a different Disease Modifying Drugs (DMDs) and Ocrelizumab using data from the real clinical practice from the Czech national multiple sclerosis patient registry (ReMuS).

Enrollment: 17,478 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Each participant must provide informed consent to registry ReMuS in accordance with local regulations
• The patient is treated by any kind of DMDs
• Confirmed diagnosis of multiple sclerosis

Exclusion criteria

• Patient withdrawal of informed consent to registry ReMuS