Status:
UNKNOWN
Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Gødstrup Hospital
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 sc...
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 disea...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06159712
Start Date
November 27 2023
End Date
November 1 2025
Last Update
December 7 2023
Active Locations (1)
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1
Aarhus University
Aarhus, Denmark, 8000