Comparing treatments for relapsing multiple sclerosis

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

This study is testing how different strong treatments for relapsing multiple sclerosis affect patients' immune responses and B cell levels over a year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Aarhus (other)
• Drugs / interventions: alemtuzumab, daclizumab, rituximab, ocrelizumab, ofatumumab, natalizumab
• Locations: 1 site (Aarhus)
• Trial ID: NCT06159712 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare immunologic, virologic, and epigenetic factors in patients with active relapsing multiple sclerosis receiving high-efficacy disease-modifying treatments such as ocrelizumab, rituximab, ofatumumab, or natalizumab. The study will include participants aged 18-65 who meet specific criteria for second-line treatment and will analyze their responses compared to healthy controls. Participants will provide additional blood samples during routine testing over a 12-month period, with the possibility of extending for another year. The primary focus is on changes in B cell populations among the different treatment groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with active relapsing remitting multiple sclerosis who meet specific treatment criteria.

Not a fit: Patients who are pregnant, breastfeeding, or lack effective contraception may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding of treatment responses in relapsing multiple sclerosis, potentially enhancing patient outcomes.

How similar studies have performed: Other studies have shown promise in comparing treatment responses in multiple sclerosis, but this specific approach is relatively novel.

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

Where this trial is running

Aarhus

• Aarhus University — Aarhus, Denmark (RECRUITING)

Study contacts

• Study coordinator: Camilla Mærsk-Møller, MD

Conditions: Relapsing Remitting Multiple Sclerosis