Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

NCT05762003 | Completed FDA Drug

• 1 other identifier: ML41011
• Study Type: observational
• Target: 17,478
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Effectiveness in relapses

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

  1 year from DMD initiation

• 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 Outcomes (2)

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

  Baseline

• Description of termination of different DMDs treatment

  Day of DMD termination, assessed up to 15 years

Interventions

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

Administered as part of routine clinical practice.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from primary patient care and included in patient registry ReMuS.

You may qualify if:

• 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

You may not qualify if:

• Patient withdrawal of informed consent to registry ReMuS

Sponsors & Collaborators

• IMPULS Endowment Fund: lead

Study Sites (1)

IMPULS Endowment Fund

Prague, 12000, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferons; Glatiramer Acetate; teriflunomide; Dimethyl Fumarate; Alemtuzumab; Cladribine; Fingolimod Hydrochloride; ponesimod; Rituximab; ocrelizumab; ofatumumab; Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Sphingosine; Amino Alcohols; Alcohols; Propylene Glycols; Glycols; Amines; Antibodies, Monoclonal, Murine-Derived

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 9, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

CZ (1)