Relapsing Remitting Multiple SclerosisCoSHEDRMSNCT06159712
Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
A study testing Blood samples in people with Relapsing Remitting Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this prospective, multi-center, non-blinded, non-randomized, non-intervention clinical trial is to compare immunologic, virologic and epigenetic factors in patients with active multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab or natalizumab in Region Midt, Denmark. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Nov 2023to Nov 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Multiple sclerosis diagnosis and definition of disease course according to the 2017 McDonald criteria
- Expanded disability status scale (EDSS) ≤6.5
- Signed written informed consent
- Fulfilling criteria for active MS: Treatment naïve relapsing remitting multiple sclerosis (RRMS) patients (never treated, or no DMT the previous 2 years):
- 2 relapse previous 12 months OR
- 1 relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR
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- 1 relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND
- contrast-enhancing lesion or ≥1 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 12 month
- Previously treated RRMS patients:
- 1 relapse previous 12 months OR
- 1 contrast-enhancing lesion or ≥2 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months
Who cannot join
- Pregnancy or breast feeding
- Lack of effective contraception for women of child-bearing potential (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate <1%)
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
- Known active malignant disease
- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- Positive test for HIV, hepatitis B or C, or tuberculosis
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- Negative test for varicella zoster
- Lymphopenia grade 2 (0.5 to 0.8 × 10^9/L) or higher grades of lymphopenia (in case of switching from fingolimod lymphopenia grade 2 can be accepted if lymphocytes are rising markedly compared to on treatment levels)
- Neutropenia grade 2 (1.0 to 1.5 × 10^9/L) or higher grades
- Thrombocytopenia grade 2 (50 to 75 × 10^9/L) or higher grades
- Previous treatment with alemtuzumab or hematopoietic stem-cell transplantation
- Previous treatment with cladribine, CD20-depleting antibodies, daclizumab or other immune suppressive treatment which is judged to still exert immune suppressive effect by treating physician
- Methylprednisolone treatment within 1 month of baseline visit
- Findings on the screening MRI judged to preclude participation by the treating physician
- Other diseases judged to be relevant by the treating physician
- Contraindication to MRI
- Known allergy or hypersensitivity to rituximab or ocrelizumab, rituximab, ofatumumab or natalizumab
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University
Aarhus, 8000
Helene Nørrelund, +4593508486, hwn@au.dk
Camilla Mærsk-Møller, MD, +4521392792, cammae@rm.dk
About this study
The goal of this prospective, multi-center, non-blinded, non-randomized, non-intervention clinical trial is to compare immunologic, virologic and epigenetic factors in patients with active multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab or natalizumab in Region Midt, Denmark. It aims to answer how the immunologic, virologic and epigenetic response in these patients are compared to healthy controls, and analyze their treatment effect in relation to this response. Participants will get an extra blood sample, when they have their routine blood samples taken.
Read the detailed description
The CoSHED RMS study will include patients with active multiple sclerosis aged 18-65 years fulfilling the criteria for 2. line treatment and starting treatment with one of the four high-efficacy disease modifying treatments ocrelizumab, rituximab, ofatumumab or natalizumab. Researchers will compare immunologic, virologic and epigenetic parameters in the four treatment groups to a age and gender matched healthy control group. The study duration is 12 months, and patients can continue in an extension phase for additional 12 month. The primary endpoint is changes in B cell populations between the four treatments within 12 months. The study will evaluate a number of efficacy and safety endpoints using clinical, MRI, routine blood samples and research biomarkers.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Blood samples
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Extra blood samples
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab | Other | Patients with active multiple sclerosis starting standard treatment with ocrelizumab Receives: Other: Blood samples |
| Rituximab | Other | Patients with active multiple sclerosis starting standard treatment with rituximab Receives: Other: Blood samples |
| Ofatumumab | Other | Patients with active multiple sclerosis starting standard treatment with ofatumumab Receives: Other: Blood samples |
| Natalizumab | Other | Patients with active multiple sclerosis starting standard treatment with natalizumab Receives: Other: Blood samples |
| Healthy controls | Other | An age and gender matched healthy control group Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in B cell populations
Changes in B cell populations in the four treatment groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start27 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Researchers compare immunologic, virologic and epigenetic factors in patients with multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab and natalizumab by taking extra blood samples and compare it to a healthy control group.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Gødstrup Hospital, Regionshospitalet Viborg, Skive, Sorbonne University
- Responsible party
- Sponsor
- Investigators
- Morten Stilund, MD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159712
- Sponsor's protocol ID
- CoSHED
- Acronym
- CoSHEDRMS
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06159712
- Acronym / sponsor ID
- CoSHEDRMS / CoSHED
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Gødstrup Hospital, Regionshospitalet Viborg, Skive, Sorbonne University
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 7 Dec 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.
The goal of this prospective, multi-center, non-blinded, non-randomized, non-intervention clinical trial is to compare immunologic, virologic and epigenetic factors in patients with active multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab or natalizumab in Region Midt, Denmark. It aims to answer how the immunologic, virologic and epigenetic response in these patients are compared to healthy controls, and analyze their treatment effect in relation to this response. Participants will get an extra blood sample, when they have their routine blood samples taken.
Detailed description
The CoSHED RMS study will include patients with active multiple sclerosis aged 18-65 years fulfilling the criteria for 2. line treatment and starting treatment with one of the four high-efficacy disease modifying treatments ocrelizumab, rituximab, ofatumumab or natalizumab. Researchers will compare immunologic, virologic and epigenetic parameters in the four treatment groups to a age and gender matched healthy control group. The study duration is 12 months, and patients can continue in an extension phase for additional 12 month. The primary endpoint is changes in B cell populations between the four treatments within 12 months. The study will evaluate a number of efficacy and safety endpoints using clinical, MRI, routine blood samples and research biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Researchers compare immunologic, virologic and epigenetic factors in patients with multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab and natalizumab by taking extra blood samples and compare it to a healthy control group.
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab | Other | Other: Blood samplesPatients with active multiple sclerosis starting standard treatment with ocrelizumab |
| Rituximab | Other | Other: Blood samplesPatients with active multiple sclerosis starting standard treatment with rituximab |
| Ofatumumab | Other | Other: Blood samplesPatients with active multiple sclerosis starting standard treatment with ofatumumab |
| Natalizumab | Other | Other: Blood samplesPatients with active multiple sclerosis starting standard treatment with natalizumab |
| Healthy controls | Other | Other: Blood samplesAn age and gender matched healthy control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Multiple sclerosis diagnosis and definition of disease course according to the 2017 McDonald criteria
- Expanded disability status scale (EDSS) ≤6.5
- Signed written informed consent
- Fulfilling criteria for active MS: Treatment naïve relapsing remitting multiple sclerosis (RRMS) patients (never treated, or no DMT the previous 2 years):
- 1 relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR
Key exclusion criteria (17 listed)
- Pregnancy or breast feeding
- Lack of effective contraception for women of child-bearing potential (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate <1%)
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
- Known active malignant disease
- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
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 |
|---|---|---|
| Blood samplesExtra blood samples | Other | Healthy controls, Natalizumab, Ocrelizumab, Ofatumumab, Rituximab |
Primary outcome
Changes in B cell populations
Time frame: 1 year
Changes in B cell populations in the four treatment groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Morten Stilund, MD study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Relapsing Remitting Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
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 11 inclusion and 17 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 7 Dec 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 Denmark. 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?
Contact Camilla Mærsk-Møller, MD (+4521392792, cammae@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in B cell populations (time frame: 1 year). 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 7 Dec 2023.