A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

Description

Patient Inclusion Criteria:

  • Ages 18-65
  • 1 Relapse in Past Year/2 Relapses in Past 2 years
  • No Assistive Device to Walk/Use Cane but can walk 500 meters with C
  • Written informed consent must be obtained before any assessment is performed
  • Male and female patients 18 to 65 years of age, inclusive.
  • Patients with RRMS, as defined by 2010 revised McDonald criteria.
  • Patients must be neurologically stable with no onset of relapse or any steroid use within 30 days of randomization
  • Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.
  • Patients with an EDSS score of 0 to 6 inclusive at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting.
  • Patients treated with interferon beta or glatimer acetate can continue their treatment until randomization

Patient Exclusion Criteria:

  • Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma)
  • Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).
  • Patients who have been treated with:
    • High-dose intravenous (IV) immunoglobulin (Ig) within 2 months before randomization
    • Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
    • Monoclonal antibodies (including natalizumab) within 6 months before randomization
    • Rituximab, alemtuzumab, ofatumumab, ocrelizumab, mitoxantrone or cladribine at any time before randomization
    • Patients who have been treated with corticosteroids or adrenocorticotropic hormones in the past 30 days before the screening visit
  • Patients with uncontrolled diabetes mellitus (HbA1c >7%)
  • Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening)
  • Positive screening for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection:
    • Patients who are negative for varicella zoster virus IgG antibodies at Screening
    • Patients who have received any live or live attenuated vaccines (including for varicella zoster virus, herpes simplex, or measles) within 1 month before randomization
    • Patients who have received total lymphoid irradiation or bone marrow transplantation
    • Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site

Details
Clinical Study IdentifierTX136816
Last Modified on25 March 2021

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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