Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Colorado, Denver
Ten patients \>18 years of age with a minimum of 2 years of MS disease stability (no relapse or new magnetic resonance imaging lesions) and at least one year of experience on an anti-CD20 agent prior to initiating de-escalation with diroximel fumarate (Vumerity®) or dimethyl fumarate (Tecfidera®) will be followed for 24 months post de-escalation. To account for screen failures and withdrawals, up to 15 may be enrolled.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Any progression of neurological symptoms in the year prior to the screening visit that would be consistent with progressive MS.
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.)
Clareo Health | Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
