Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
NCT ID: NCT06159712
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-11-27
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Ocrelizumab
Patients with active multiple sclerosis starting standard treatment with ocrelizumab
Blood samples
Extra blood samples
Rituximab
Patients with active multiple sclerosis starting standard treatment with rituximab
Blood samples
Extra blood samples
Ofatumumab
Patients with active multiple sclerosis starting standard treatment with ofatumumab
Blood samples
Extra blood samples
Natalizumab
Patients with active multiple sclerosis starting standard treatment with natalizumab
Blood samples
Extra blood samples
Healthy controls
An age and gender matched healthy control group
Blood samples
Extra blood samples
Interventions
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Blood samples
Extra blood samples
Eligibility Criteria
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Inclusion 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
1 relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND
1. 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
Exclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Gødstrup Hospital
OTHER
Regionshospitalet Viborg, Skive
OTHER
Sorbonne University
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Morten Stilund, MD
Role: STUDY_DIRECTOR
University of Aarhus
Locations
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Aarhus University
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Helene Nørrelund
Role: primary
Camilla Mærsk-Møller, MD
Role: backup
Other Identifiers
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CoSHED
Identifier Type: -
Identifier Source: org_study_id