Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 10:25 AM
Study NCT ID:
NCT05762003
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Czech Pharmaco-epidemiological Study on Disease Modifying Drugs
Sponsor:
IMPULS Endowment Fund
Organization:
Study Overview
Official Title:
Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPE
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: