Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis

Launched by UNIVERSITY OF AARHUS · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well certain treatments work for people with active relapsing multiple sclerosis (MS). The researchers want to compare the effects of four specific medications—ocrelizumab, rituximab, ofatumumab, and natalizumab—on the immune system and other factors in patients with MS, and see how these responses compare to healthy individuals. By understanding these differences, the trial aims to learn more about how effective these treatments are in managing MS.

To participate in this study, you must be diagnosed with relapsing remitting MS and meet certain health criteria, such as having had at least one relapse in the past year. If you join the trial, you will have an extra blood sample taken during your routine blood tests. This study is open to all adults aged between 18 and 65, and it is currently recruiting participants. It's important to note that certain health conditions and treatments may prevent you from participating, and your doctor will guide you through this process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 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:
• • 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