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Active Not Recruiting
NCT07757568
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
Conditions: Multiple Sclerosis (MS) Relapsing Remitting
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 11
Sponsor: University of Colorado, Denver
Location: University of Colorado, Denver Aurora Colorado
Summary
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 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 \
Source: ClinicalTrials.gov (NCT07757568). StuddyBuddy aggregates publicly available trial information.