A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults Who Are in Early Stages of Treatment for Relapsing Remitting Multiple Sclerosis

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults Who Are in Early Stages of Treatment for Relapsing Remitting Multiple Sclerosis

Description

Patient Inclusion Criteria:

  • Ages 18-65
  • No MS relapses required for study entry
  • Written informed consent must be obtained prior to any assessment being performed.
  • Male and female patients aged 18-65 years inclusive.
  • Patients diagnosed with relapsing remitting MS, defined by the 2010 revised McDonald criteria
  • EDSS score of less than or equal to 6.
  • Patients naive to treatment or who have been treated with no more than one class of DMT previously (interferon ß preparation or glatiramer acetate); total treatment exposure ≤ 5 years; and who, per investigator judgment, may benefit from a change of treatment class.
  • Women of childbearing potential must have a negative urine and serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and at baseline.

Details
Clinical Study IdentifierTX136809
Last Modified on8 November 2020

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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