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Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)

NCT07757568

Active Not RecruitingN/A

Sponsor: University of Colorado, Denver

Conditions: Multiple Sclerosis (MS) Relapsing Remitting

Interventions: Vumerity, Tecfidera

Countries: United States

The investigators propose a multi-center pilot study, which aims to evaluate safety and efficacy of fumarates as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosed with relapsing forms of MS
* \> 18 years of age at the time of initiation of de-escalation
* No evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for at least two years prior to de-escalation
* Have had multiple sclerosis related symptoms at least 3 years prior to baseline visit.
* Taking an anti-CD20 therapy most recently as a DMT continuously for at least one year (have received at least 2 courses) prior to de-escalation.
* Are 6-12 months from their last anti-CD20 infusion
* Willing to follow the protocol
* Able to undergo a brain MRI without anesthesia

Exclusion Criteria:

* Any progression of neurological symptoms in the year prior to the screening visit that would be consistent with progressive MS.
* Use of any non-FDA-approved DMT or systemic corticosteroids in the last 2 years. (Note: Use of inhaled or topical steroids are not an exclusion criteria. Also, use of oral steroids for no greater than 14 days given for a non-MS condition is not exclusionary).
* IgG levels \<300 mg/dL
* lymphocytes \<800 cells/mm3
* EDSS \>6.5
* Is considering pregnancy at the screening visit
* Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine or any experimental MS treatment in the last 5 years.
* Prior allergy to Vumerity
* Other significant medical or psychiatric illness, if uncontrolled. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression
* Cancers other than basal cell skin cancers within the last 5 years
* Unable to give informed consent or follow the protocol.
* Unable to undergo brain MRI.
* History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)

Locations (1)

Aurora, Colorado, United States