Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

Completed · Phase 4

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.

Key facts

Study ID

NCT01623596

Run by

Novartis Pharmaceuticals

People needed

881

Starts

2012-06-08

Expected to finish

2015-07-13

Last updated by the study team

2021-01-05

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 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 (Pollman et al, 2011) (Appendix 1).
• 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 β preparation or glatiramer acetate), and who, per investigator judgment, may benefit from a change of treatment class.
• Patients who have been treated with DMF for less than 2 months total exposure and who have a normal lymphocyte count at screening.
• Women of childbearing potential must have a negative urine and serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and at baseline.
• Before entry women must be:
• Post menopausal for at least 1 year, or
• Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise incapable of pregnancy, or
• Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study, or
• Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) 4.2 Exclusion criteria
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• Use of other investigational drugs within 30 days of screening.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Prior exposure to fingolimod or any other S1P receptor modulating compounds.
• History or presence of malignancy of any organ system (other than successfully treated basal or squamous cell carcinoma of the skin or stage 0 carcinoma of the cervix), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Patients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Primary Progressive MS (PPMS).
• Patients with a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
• Patients who have been treated with:
• Natalizumab, mitoxantrone, cladribine, rituximab, alemtuzumab, ofatumumab, ocrelizumab at any time before randomization
• Immunoglobulins, or pulse of corticosteroids with more than 6 months cumulative exposure
• Immunosuppressive/chemotherapeutic medications (e.g., methotrexate, azathioprine, cyclophosphamide, cellcept, Cytoxan, IVIG) with more than 6 months of cumulative exposure and within 6 months prior to randomization
• Corticosteroids or adrenocorticotropic hormones in the past 30 days before randomization. Patients that require corticosteroids for a relapse during the screening period may be rescreened 30 days after the last dose.
• History of treatment with both classes of approved first line DMT (interferon β preparation and glatiramer acetate) or DMF exposure of 2 months or longer.

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Sun City, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Sherwood, Arkansas, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Basalt, Colorado, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Fort Collins, Colorado, United States
• Novartis Investigative Site — Fairfield, Connecticut, United States
• Novartis Investigative Site — New London, Connecticut, United States
• Novartis Investigative Site — Dover, Delaware, United States
• Novartis Investigative Site — Atlantis, Florida, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Delray Beach, Florida, United States
• Novartis Investigative Site — Hollywood, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — North Palm Beach, Florida, United States
• Novartis Investigative Site — Plantation, Florida, United States
• Novartis Investigative Site — Pompano Beach, Florida, United States
• Novartis Investigative Site — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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