MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Stopped early · Phase 3

Conditions studied: Relapsing-remitting Multiple Sclerosis (RRMS)

In brief

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

Key facts

Study ID

NCT01633112

Run by

Novartis Pharmaceuticals

People needed

1064

Starts

2012-08-09

Expected to finish

2018-04-30

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma) in the last 5 years that do not have confirmation of absence of a malignancy prior to randomization
• 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 4 weeks before randomization
• Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
• Natalizumab within 2 months before randomization
• Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization
• Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization.
• No washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate.
• Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period).
• Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure.
• Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with diabetic neuropathy.
• 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).
• Patients with severe active bacterial, viral, or fungal infections.
• Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization.
• Patients who have received any live or live-attenuated vaccines (including VZV, 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.
• Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure.

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Fort Collins, Colorado, United States
• Novartis Investigative Site — Loveland, Colorado, United States
• Novartis Investigative Site — Fairfield, Connecticut, United States
• Novartis Investigative Site — Newark, Delaware, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Maitland, Florida, United States
• Novartis Investigative Site — Naples, Florida, United States
• Novartis Investigative Site — New Port Richey, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Ormond Beach, Florida, United States
• Novartis Investigative Site — Pompano Beach, Florida, United States
• Novartis Investigative Site — Ponte Vedra Beach, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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