A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.
Multicenter, Open Label, Prospective Study examining the safety and efficacy of de-escalation therapy to ozanimod (Zeposia®) over 36 months from anti-CD20 therapy for stable patients with relapsing forms of MS. A comparison to patients continuing anti-CD20 treatment was performed with propensity scoring to a cohort of at least 500 patients followed at Cleveland Clinic and the University of Colorado who also meet the above the inclusion and exclusion criteria. Patients were followed for 36 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
De-escalation of anti-CD20 treatment using ozanimod.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGCleveland Clinic
Las Vegas, Nevada, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGNew T2 lesions count
Number of new T2 lesions on MRI scans.
Time frame: 36 months
Serious infections
Infections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days.
Time frame: 36 months
Relapses
Protocol and/or suspected relapses
Time frame: 36 months
IgG and IgM levels
IgG and IgM levels
Time frame: 36 months
Infections
All infections including opportunistic infections.
Time frame: 36 months
No Evidence of Disease Activity (NEDA-3)
Not meeting any of the following criteria: 1. Evidence of Relapse activity - collected every 3 months via phone calls/clinic visits. 2. MRI disease activity - presence of new T2 lesions from MRI scans conducted at any timepoint. 3. 6 months Confirmed Disability progression (CDP6): measured by the EDSS assessed at baseline and every 6 months. CDP6 is defined as an increase in Expanded Disability Status Scale (EDSS) score of ≥1.5 if baseline EDSS was 0; or ≥1.0 points if baseline EDSS was ≥0.5-≤5.5; or by ≥0.5 points if baseline EDSS ≥6, sustained over two consecutive visits.
Time frame: 36 months
Neurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)
Neurofilament light (NfL) and Glial Fibrillary Acid Protein (GFAP)
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Brain parenchymal and thalamic volume loss
Brain parenchymal and thalamic volume loss
Time frame: 36 months
Adverse Events
Adverse Events
Time frame: 36 months