Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

NCT05762003 — Completed, 17478 participants, IMPULS Endowment Fund

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Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs

Registry	NCT05762003, acronym CPE
Status	Completed
Study type	Observational
Enrollment	17478 (Actual)
Sponsor	IMPULS Endowment Fund (Other)
Conditions	Multiple Sclerosis
Interventions	interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab (Drug)
Dates	start 2019-01-01, primary completion 2021-12-31, completion 2021-12-31, first posted 2023-03-09, last updated 2023-03-09
Locations	1 site in Czechia

-Summary

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).

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+Arms and interventions

interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab (Drug): Administered as part of routine clinical practice.

+Outcome measures

Primary outcomes

Effectiveness in relapses [1 year from DMD initiation]: Measurement of annualized relapse rate (ARR) in patients on different DMDs.
Effectiveness EDSS [1 year from DMD initiation]: Description of disability measured by Expanded Disability Status Scale (EDSS) of values 0 to 10, where 0 represents no neurological disability due to multiple sclerosis (MS), and 10 represents death due to MS. The EDSS is commonly used among clinicians, and described by Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983; 33(11): 1444-1452.

Secondary outcomes

Description of baseline characteristics of patients treated by different DMDs at the time of DMT initiation [Baseline]: Baseline characteristics (age, sex, disease duration, previous treatment, type of MS) of patients treated with different DMDs
Description of termination of different DMDs treatment [Day of DMD termination, assessed up to 15 years]: Number of patients that terminate treatment on particular DMDs

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
IMPULS Endowment Fund	Prague	Czechia