Czech Pharmaco-epidemiological Study on Disease Modifying Drugs

Sponsor
IMPULS Endowment Fund
Study ID
NCT05762003
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jan 1, 2019
Status verified
Mar 2023
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
17,478 participants (actual)

Primary Outcome Measure

Effectiveness in relapses [ Time Frame: 1 year from DMD initiation ]

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