Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

Study Overview
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Brief Summary
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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).

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |