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8110 Gatehouse Road, Falls Church, VA 22042

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab (ARTIOS)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

COMB157G23101

Background Information

The open label study to evaluate effectiveness of treatment with ofatumumab in patients transitioning from commonly used oral MS therapies - fingolimod or dimethyl fumarate, due to breakthrough disease.

ClinicalTrials.gov ID: NCT04353492

Offered At

Inova Medical Group – Neurology
8081 Innovation Park Dr., #900
Fairfax, VA 22031

Eligibility Information

  • Adults (ages 18 to 60 years)
  • Diagnosis of multiple sclerosis (MS)
  • Relapsing MS (RRMS or SPMS) course
  • Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
  • Breakthrough disease as evidence by clinical relapses or MRI
  • EDSS score of 0 to 4

Ineligibility Information

  • Primary progressive MS or SPMS without disease activity
  • Disease duration of more than 10 years since diagnosis
  • Patients with an active chronic disease of the immune system other than MS
  • Patients at risk of developing or having reactivation of hepatitis
  • Patients with active systemic infections or with neurological findings consistent with PML other protocol-defined inclusion/exclusion criteria may apply

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04353492?term=COMB157G23101&draw=2&rank=1