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NCT Number: NCT05762003

Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

IMPULS Endowment Fund

Prague, 12000, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Administered as part of routine clinical practice.

Primary outcomes

  1. Effectiveness in relapses

    Time frame: 1 year from DMD initiation

    Measurement of annualized relapse rate (ARR) in patients on different DMDs.

  2. Effectiveness EDSS

    Time frame: 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

  1. Description of baseline characteristics of patients treated by different DMDs at the time of DMT initiation

    Time frame: Baseline

    Baseline characteristics (age, sex, disease duration, previous treatment, type of MS) of patients treated with different DMDs

  2. Description of termination of different DMDs treatment

    Time frame: Day of DMD termination, assessed up to 15 years

    Number of patients that terminate treatment on particular DMDs

Sponsors and collaborators

Lead sponsor

IMPULS Endowment Fund

Other

Registry information

Official study title

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

Acronym: CPE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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