5283W-12 A 12-month, randomized, blinded study to compare the efficacy and safety of fingolimod 0.25

A 12-month, randomized, 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 multiple sclerosis.

Type of Study
Neuroscience - Multiple Sclerosis
Short Description

The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to copaxone (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the treatment of patients with relapsing-remitting MS (RRMS) as part of a post approval commitment for the FDA.

Status
Open
Principal Investigator
Lily Jung Henson, MD
Eligibility Notes
  • Male and female patients 18 to 65 years of age, with RRMS and at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years are eligible.
  • Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma), or 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) are not eligible to participate in this study
Contact Name
Colleen Ottinger and Amanda Brown
Phone
206-320-3695
Alternate Phone
206-320-2604
Email
colleen.ottinger@swedish.org
Alternate Email
amanda.brown@swedish.org