Multiple SclerosisCPENCT05762003
Czech Pharmaco-epidemiological Study on Disease Modifying Drugs
An observational study of Multiple Sclerosis, run by IMPULS Endowment Fund at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab
- How many people
- 17,478 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from primary patient care and included in patient registry ReMuS.
Who may be able to join
- 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
Who cannot join
- Patient withdrawal of informed consent to registry ReMuS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs
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.
Read more
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
- Being tested
- interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumabDrug
Administered as part of routine clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness in relapses
Measurement of annualized relapse rate (ARR) in patients on different DMDs.
Measured: 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.
Measured: 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 characteristics (age, sex, disease duration, previous treatment, type of MS) of patients treated with different DMDs
Measured: Baseline
Description of termination of different DMDs treatment
Number of patients that terminate treatment on particular DMDs
Measured: Day of DMD termination, assessed up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMPULS Endowment Fund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762003
- Sponsor's protocol ID
- ML41011
- Acronym
- CPE
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs
- ClinicalTrials.gov ID
- NCT05762003
- Acronym / sponsor ID
- CPE / ML41011
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,478 participants (actual)
- Lead sponsor
- IMPULS Endowment FundUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from primary patient care and included in patient registry ReMuS.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient withdrawal of informed consent to registry ReMuS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumabAdministered as part of routine clinical practice. | Drug | – |
Primary outcome
Effectiveness in relapses
Time frame: 1 year from DMD initiation
Measurement of annualized relapse rate (ARR) in patients on different DMDs.
Effectiveness EDSS
Time frame: 1 year from DMD initiation
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.
2 secondary outcomes
Description of baseline characteristics of patients treated by different DMDs at the time of DMT initiation
Time frame: Baseline
Description of termination of different DMDs treatment
Time frame: Day of DMD termination, assessed up to 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by IMPULS Endowment Fund at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness in relapses (time frame: 1 year from DMD initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.