Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

CompletadoClinicalTrials.gov

ID: NCT01442194Tipo: OBSERVATIONALInicio: 1 de ago de 2011Fin estimado: 10 de jul de 2020

Traducción no disponible, mostrando original

Resumen

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

Elegibilidad

Sexo: ALL

Criterios de inclusión

Patients that as part of their routine clinical care and according to the locally approved label, are either;
Starting fingolimod at time of study entry.
Starting another approved DMT or started within maximum 6 months prior to study entry.
Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort

Criterios de exclusión

Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab

Intervenciones

drug

other disease-modifying therapy

drug

Fingolimod

Ubicaciones

Novartis Investigative Site

Jenin, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Salta, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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