Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06529406
Phase
PHASE4
Status
Recruiting
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Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ozanimod — DRUG
    De-escalation of anti-CD20 treatment using ozanimod.

Study Details

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.

Key Dates

First listed
Jul 31, 2024
Start date
Jul 29, 2024
Status verified
Sep 2025
Primary completion
Aug 1, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ozanimod de-escalation of anti-CD20 treatment
    Ozanimod will be started 6-12 months after the last anti-CD20 infusion, including ocrelizumab subcutaneous injection, or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study.
  • No Intervention: Continued anti-CD20 treatment
    Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm.

Primary Outcome Measure

New T2 lesions count [ Time Frame: 36 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Enrique Alvarez, MD/PhD
[email protected]
303-724-8249
Haley Steinert
[email protected]
303-724-4644
Cleveland ClinicLas VegasNevada89106
Liza Mercurio
[email protected]
725-373-1590
Carrie M Hersh, DO (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Devon S Conway, MD
[email protected]
216-636-1158
Devon S Conway, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical Campus· Aurora, COCleveland Clinic· Las Vegas, NVCleveland Clinic· Cleveland, OH

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