Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      852 Patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved
      first line DMTs. Patients must be either treatment naive or have received treatment with only
      one class of treatment (interferon beta preparation or glatiramer acetate) . Patients
      previously treated with DMT and randomized to the DMT arm may not remain on the same
      treatment for the study and will have to switch to a different class (i.e., previously
      treated with glatiramer acetate will switch to interferon beta preparaption, previously
      treated with interferon beta preparation will swtich to glatiramer acetate).

      Entry criteria at screening include but are not limited to, age 18-65, diagnosis with RRMS,
      EDSS < or equal to 6, not pregnant or planning pregnancy and women of childbearing potential
      willing to use contraception throughout the study.

      Exclusion criteria include but are not limited to - prior exposure to fingolimod, history of
      malignancy within 5 years, other than RRMS types of MS, other diseases of the immune system,
      active macular edema, systemic bacterial, viral or fungal infections, patients without
      vaccine against varicella zoster, receipt of live or attentuated vaccines within a month of
      screening, history of various cardiac conditions, presence of certain ECG abnormalities,
      resting heart rate < 45 bpm, symptomatic bradycardia, recurrent syncope, severe untreated
      sleep apnea, severe pulmonary conditions, various hepatic conditions, certain neurologic
      disorders, pregnancy.

      Patients may switch treatment before 3 months for safety reasons only, after 3 months for
      safety, efficacy, tolerability or convenience. Treatment switch during the study may be to
      any of study approved treatments irrespective of prior treatment.

      Patients randomized to fingolimod will need to have 6 hours of observation for signs and
      symptoms of bradycardia following administration of the first dose. Extended observation or
      overnight observation may be necessary under certain circumstances. 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. Exploratory objectives
      include annualized relapse rate, OCT, MRI evaluations, biomarkers and patient reported
      outcome measures.
    

Intervention name(s): Fingolimod; Disease Modifying therapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment