A Randomized, Double-Blind, Placebo-Controlled, Multi-Cen... | EligiMed

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)

TerminadoFase 3ClinicalTrials.gov

ID: NCT01892345RENIS: IS001148Tipo: INTERVENTIONALInicio: 11 de abr de 2014Fin estimado: 17 de jul de 2018

Traducción no disponible, mostrando original

Resumen

The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female participants ≥ 18 years old.
Diagnosis of NMO or NMOSD.
AQP4 antibody seropositive.
Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
Expanded Disability Status Scale score ≤ 7.
If a participant entered the study receiving immunosuppressive therapy (IST) for relapse prevention, the participant must have been on a stable maintenance dose of IST(s), as defined by the treating physician, prior to Screening and must have remained on that dose for the duration of the study, unless the participant experienced a relapse.
Female participants of childbearing potential were to have a negative pregnancy test (serum human chorionic gonadotropin). Participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.

Criterios de exclusión

Use of rituximab within 3 months prior to Screening.
Use of mitoxantrone within 3 months prior to Screening.
Use of intravenous immunoglobulin within 3 weeks prior to Screening.

Intervenciones

drug

Eculizumab

Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks

drug

Placebo

Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks

Ubicaciones

Hospital General de Agudos Juan Antonio Fernandez

Ciudad Autonoma, Buenos Aires, Buenos Aires, Argentina

Hospital J. M. Ramos Mejia

Ciudad Autonoma, Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Fundacion Rosarina de Neuro Rehabilitacion

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

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