Multiple SclerosisNCT04874597
Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes with Suppressive Capacity in MS
An observational study of Multiple Sclerosis, run by Dr Recai Turkoglu at 1 site in Turkey (Türkiye).
Trial summary
This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 20 MS patients who were previously treated with at least one of other DMT will be recruited. Participants will be recruited by specialized physicians who are experienced in the diagnosis and treatment of MS and ocrelizumab use. * Consecutive MS patients with an already planned ocrelizumab therapy will be screened for recruitment in study recruiting clinics. Ocrelizumab treatment will not be initiated to recruit study patients. * MS patients will be stratified for gender to reflect epidemiological incidence of MS subtypes. Gender ratios (Female/Male) for RMS and PPMS are set for 2:1 and 1:1, respectively.
Who may be able to join
- Adults (≥18 years old) with a diagnosis of relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the 2017 revised McDonald criteria.
- Previous MS treatment with at least one of other DMT(*). The patients can be without treatment before switching until the end of wash-out period of previous DMT(s) or until lymphocytes parameter is in normal range.
- Previous treatment change with the reasons inefficacy, safety related issues or lack of compliance.
- Decision to initiate ocrelizumab therapy (in accordance with the product characteristics approved in Turkey) has already been taken for the treatment of MS patient as part of routine clinical practice. The decision to treat with Ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study.
- Agreed and signed informed consent.
- () A DMT is defined as any of the following drugs: Teriflunomide, Interferon beta 1a, Interferon beta 1b, Peginterferon beta 1a, Glatiramer acetate, Fingolimod, Daclizumab, Alemtuzumab, Cladribine, Dimethyl fumarate, and Natalizumab.
Who cannot join
- Previously treated with anti-CD20 therapy (rituximab, atacicept, belimumab or ofatumumab).
- Medical history of a malignancy, active infection (including Hepatitis B virus) or chronic inflammatory disease.
- Medical history or use of any medication other than a DMT as defined above which may affect immunophenotypes of the participants.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department
Istanbul, Uskudar, 34668
About this study
Official title: The Effect of Ocrelizumab on the Peripheral Lymphocyte Immunophenotypes with Suppressive Capacity in Patients with Multiple Sclerosis Previously Treated with Disease Modifying Therapy - a Prospective Exploratory Observational Study
This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab.
Read the detailed description
This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab. The study will be conducted on Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department.
The decision to treat with ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study and in line with the Summary of Product Characteristics (SmPC) approved by the Turkish Ministry of Health.
Data will be recorded at screening visit, baseline visit (month 0), second visit on 6th month, third visit on 12th month and last visit (end of the study [EOS]) on 24th month according to local clinic practice. Optional ad hoc visits could be conducted if relapse of MS or infection after vaccination occurs during ocrelizumab treatment.
The duration of the study for each patient will be 24 months.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab
- Keywords
- Ocrelizumab, Disease modifying therapy, T cell, B cell
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Ocrelizumab treatment will be administered in accordance with the product characteristics approved in Turkey.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in T cell capacity achieved by eliminating B cells as measured by flow cytometry.
Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.
Measured: From baseline to month 6 and month 12
Change from baseline in T cell function achieved by eliminating B cells as measured by flow cytometry.
Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.
Measured: From baseline to month 6 and month 12
Secondary outcomes (4)
Correlation between changes in T and B cell capacity and function during course of ocrelizumab therapy.
Measured: Baseline (month 0), month 6 and month 12
Clinical improvement
Clinical improvement will be confirmed if an increase of less than half a step on the Expanded Disability Status Scale and less than one attack were observed during the first 12 months of ocrelizumab treatment.
Measured: Baseline (month 0), month 6 and month 12
Changes in T cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.
Measured: From baseline (month 0) to month 6 and month 12
Changes in B cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.
Measured: From baseline (month 0) to month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start15 Nov 2021
- Primary completion10 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Recai Turkoglu
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Responsible party
- Sponsor-investigator, Dr Recai Turkoglu, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874597
- Sponsor's protocol ID
- ML42254
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ocrelizumab on the Peripheral Lymphocyte Immunophenotypes with Suppressive Capacity in Patients with Multiple Sclerosis Previously Treated with Disease Modifying Therapy - a Prospective Exploratory Observational Study
- ClinicalTrials.gov ID
- NCT04874597
- Acronym / sponsor ID
- ML42254
- Conditions
- Multiple Sclerosis
- Keywords
- Ocrelizumab, Disease modifying therapy, T cell, B cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr Recai TurkogluUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 5 May 2021 (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.
This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab.
Detailed description
This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab. The study will be conducted on Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department.
The decision to treat with ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study and in line with the Summary of Product Characteristics (SmPC) approved by the Turkish Ministry of Health.
Data will be recorded at screening visit, baseline visit (month 0), second visit on 6th month, third visit on 12th month and last visit (end of the study [EOS]) on 24th month according to local clinic practice. Optional ad hoc visits could be conducted if relapse of MS or infection after vaccination occurs during ocrelizumab treatment.
The duration of the study for each patient will be 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20 MS patients who were previously treated with at least one of other DMT will be recruited. Participants will be recruited by specialized physicians who are experienced in the diagnosis and treatment of MS and ocrelizumab use. * Consecutive MS patients with an already planned ocrelizumab therapy will be screened for recruitment in study recruiting clinics. Ocrelizumab treatment will not be initiated to recruit study patients. * MS patients will be stratified for gender to reflect epidemiological incidence of MS subtypes. Gender ratios (Female/Male) for RMS and PPMS are set for 2:1 and 1:1, respectively.
Key inclusion criteria (6 listed)
- Adults (≥18 years old) with a diagnosis of relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the 2017 revised McDonald criteria.
- Previous MS treatment with at least one of other DMT(*). The patients can be without treatment before switching until the end of wash-out period of previous DMT(s) or until lymphocytes parameter is in normal range.
- Previous treatment change with the reasons inefficacy, safety related issues or lack of compliance.
- Decision to initiate ocrelizumab therapy (in accordance with the product characteristics approved in Turkey) has already been taken for the treatment of MS patient as part of routine clinical practice. The decision to treat with Ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study.
- Agreed and signed informed consent.
Key exclusion criteria (3 listed)
- Previously treated with anti-CD20 therapy (rituximab, atacicept, belimumab or ofatumumab).
- Medical history of a malignancy, active infection (including Hepatitis B virus) or chronic inflammatory disease.
- Medical history or use of any medication other than a DMT as defined above which may affect immunophenotypes of the participants.
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 |
|---|---|---|
| OcrelizumabOcrelizumab treatment will be administered in accordance with the product characteristics approved in Turkey. | Drug | – |
Primary outcome
Change from baseline in T cell capacity achieved by eliminating B cells as measured by flow cytometry.
Time frame: From baseline to month 6 and month 12
Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.
Change from baseline in T cell function achieved by eliminating B cells as measured by flow cytometry.
Time frame: From baseline to month 6 and month 12
Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.
4 secondary outcomes
Correlation between changes in T and B cell capacity and function during course of ocrelizumab therapy.
Time frame: Baseline (month 0), month 6 and month 12
Clinical improvement
Time frame: Baseline (month 0), month 6 and month 12
Changes in T cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.
Time frame: From baseline (month 0) to month 6 and month 12
Changes in B cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.
Time frame: From baseline (month 0) to month 6 and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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 Dr Recai Turkoglu at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Change from baseline in T cell capacity achieved by eliminating B cells as measured by flow cytometry. (time frame: From baseline to month 6 and month 12). 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 15 Oct 2024.