MS Trial Alert: Investigators Recruiting for Phase IV Study of Aubagio (teriflunomide) to Explore Ef - National Multiple Sclerosis Society

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MS Trial Alert: Investigators Recruiting for Phase IV Study of Aubagio (teriflunomide) to Explore Effectiveness, Tolerability and Patient Satisfaction

October 2, 2013

Summary: Investigators worldwide are recruiting 1,000 people with relapsing MS for a study to determine the effectiveness, tolerability and convenience of Aubagio® (teriflunomide, Genzyme, a Sanofi Company) treatment in people who have never been on this therapy. This study is using patient-reported outcomes to assess satisfaction. The study is funded by Sanofi.  The goal is to enroll 500 people in US.

Rationale: Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Teriflunomide is a novel oral compound that inhibits the function of specific immune cells. The U.S. Food and Drug Administration has approved teriflunomide once-daily pills (Aubagio,® Genzyme, a Sanofi company) to treat relapsing forms of MS.

This post-marketing study is using patient-reported outcomes, which involve measuring one or more aspects of a patient’s health status based on information gathered directly from the individual, without interpretation by physicians or others. This helps capture how a patient feels or functions with respect to her/his health, condition, or disease. Patient-reported outcomes can help determine the impact of a treatment on a person's perception of his or her symptoms and quality of life, which are difficult to capture by other objective measures.

Eligibility and Details: Participants are 18 years or older, with a diagnosis of relapsing MS, who have never received treatment with teriflunomide. Further inclusion/exclusion criteria are available from the study contacts referred to below.

Participants are being prescribed one of the two approved doses of teriflunomide – 7 mg or 14 mg - and are taking the treatment by mouth once daily for 48 weeks. Both prescribing physician and patient will know the treatment – this study is not blinded.

The purpose of this study is to evaluate overall satisfaction of Aubagio® treatment including effectiveness, tolerability, convenience, and improvement from disease progression from patient point of view through the evaluation of Questionnaires, called Patient Reported Outcomes (PROs).

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you, as listed in the study listing on our Web site.

Sites are enrolling in the following cities:

  • Bismarck, ND
  • Bradenton, FL
  • Canton, OH
  • Colorado Springs, CO
  • Cullman, AL
  • Dayton, OH
  • Denver, CO
  • Englewood, CO
  • Fort Wayne, IN
  • Henderson, NV
  • Indianapolis, IN
  • Latham, NY
  • Lincoln, NE
  • Milwaukee, WI
  • Newport Beach, CA
  • Ormond Beach, FL
  • Phoenix, AZ
  • Raleigh, NC
  • Richmond, VA
  • Roanoke, VA
  • Rockport, ME
  • Springfield, MA
  • Toms River, NJ
  • Tullahoma, TN
  • Vienna, VA

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.