Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

Multiple Sclerosis Clinical Trial

— CPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762003
• Other study ID #: ML41011
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: IMPULS Endowment Fund
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17478
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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

Locations

Country	Name	City	State
Czechia	IMPULS Endowment Fund	Prague

Sponsors (1)

Lead Sponsor	Collaborator
IMPULS Endowment Fund

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness in relapses	Measurement of annualized relapse rate (ARR) in patients on different DMDs.	1 year from DMD initiation
Primary	Effectiveness EDSS	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.	1 year from DMD initiation
Secondary	Description of baseline characteristics of patients treated by different DMDs at the time of DMT initiation	Baseline characteristics (age, sex, disease duration, previous treatment, type of MS) of patients treated with different DMDs	Baseline
Secondary	Description of termination of different DMDs treatment	Number of patients that terminate treatment on particular DMDs	Day of DMD termination, assessed up to 15 years