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Clinical Trial - ASCLEPIOS

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Mercy Research Inc. at the MS Center of St. Louis
1176 Town and Country Commons
Chesterfield, MO 63017
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A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis.
The main purpose of the study is to find out if patients treated with ofatumumab may experience fewer MS relapses (also called clinical attacks , exacerbations or flare ups) than patients treated with Aubagio® (also known as teriflunomide). Teriflunomide is an approved medication for the treatment of relapsing MS.

Participant Criteria:  (age, type of MS (if necessary),
  • Must be able to provide written consent
  • Male or female 18-55 years of age
  • Must have a  relapsing form of  MS (Relapsing- Remitting or Secondary Progressive)
  • Must have a least 1 documented relapse during the previous year OR 2 documented relapses during the previous 2 years OR a positive Gd-enhancing MRI scan during the previous 12 months.
  • Must be willing to undergo MRIs.
  • Can NOT have an additional chronic disease of the immune system other than MS.
  • Can NOT have had previous treatment with certain immunosuppressive or chemotherapeutic drugs.
  • Can NOT have certain cardiovascular conditions.
  • Can NOT be on certain medications to treat a cardiovascular condition.
  • Can NOT have respiratory disease, pulmonary fibrosis, COPD, etc.
  • Can NOT have chronic liver disease.
  • Can NOT have kidney disease or impairment
  • Can NOT have a history of substance abuse or any other neurologic or psychiatric condition that will affect participation in the study.
  • Can NOT have received another investigational drug or therapy within the last 30 days.
  • Can NOT be pregnant or lactating.
  • Can NOT have previously be treated with teriflunomide but stop taking it due to lack of effectiveness or tolerability.
  • Can NOT be lactose intolerant
Length of Trial: Maximal duration of 30 months
Clinical Trial Sponsor: Novartis

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Contact information

Jessica Schulte, RN, MSCN, CCRC
Jessica.Schulte@Mercy.Net
636-893-1258


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