Running, not recruitingRelapsing MSNCT07757568

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Components of No Evidence of Disease Activity (NEDA-3) components (of which are no relapse activity, no MRI disease activity and no confirmed disability progression).

    From baseline to 24 months

    Disability progressionRelapsesMRI lesions

Other measures (3)

  • Neurofilament light levels

    From baseline to 24 Months

    Blood or spinal fluid markers
  • Brain parenchymal volume loss (using Icometrix)

    From baseline to 24 Months

    MRI lesionsBrain volume loss
  • Multiple Sclerosis Functional Composite (MSFC)

    From baseline to 24 Months

    Disability progressionThinking and memoryWalking and mobilityArm and hand function

Who could take part

Relapsing MS · 18 and over

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.)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Mar 2023

    2. Main results due

      Sept 2026

    3. Finished

      Nov 2026

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