Este estudio evaluó la seguridad, tolerabilidad y eficacia de 2 dosis de fingolimod oral versus interferón β-1a para reducir la frecuencia de recaídas en pacientes con esclerosis múltiple remitente recurrente.
Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily. Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Guarda Vieja 4435, Capital Federal, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
General Urquiza 609, Buenos Aires, Argentina
Montaneses 2325, Buenos Aires, Argentina