IRB Study Number 24-1051
Status Recruiting
Phase Phase 4
Location U Building - Mellen Center
Institute Neurological Institute
Description
The purpose of this study is to learn more about how "de-escalation" therapy affects outcomes in patients with relapsing forms of multiple sclerosis (MS). This means switching from an anti-CD20 treatment (e.g., rituximab, ocrelizumab, ofatumumab) to ozanimod, a once daily oral medication. Ozanimod is approved by the Food and Drug Administration (FDA) for relapsing forms of MS.
You will be asked to attend multiple research visits, provide blood samples, attend clinical visits for neurological and physical assessments, and complete electrocardiograms (ECGs), magnetic resonance images (MRIs), and questionnaires. Participation will last about 3 years.
Compensation and parking vouchers provided.
Inclusion Criteria
- Diagnosed with relapsing forms of MS with related symptoms ≥3 years
- ≥18 years of age
- Taking anti-CD20 therapy as disease-modifying therapy (DMT) continuously for ≥2 years
- Received last anti-CD20 infusion within 6-12 months or last ofatumumab injection within 30-180 days
- Able to undergo brain MRI without anesthesia
Other criteria as listed in protocol.
Exclusion Criteria
- Evidence of new inflammatory disease activity in past 2 years
- Any progression of neurological disability in past year consistent with progressive MS
- EDSS >6.5
- History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms
Other criteria as listed in protocol.
