CPE: Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

Sponsor

IMPULS Endowment Fund (Other)

Overall Status

Completed

CT.gov ID

NCT05762003

Collaborator

(none)

17,478

Enrollment

Location

Actual Duration (Months)

485.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab

Study Design

Study Type:

Observational

Actual Enrollment :

17478 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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