Wyeth [Pfizer] (Takeuchi et al) [provisional name] (Etanercept for rheumatoid arthritis [provisional name])
ID: 59efefa06ec0d6096155cd82
2 Documentos
Cerrar
2 Referencias ( articles) loading Revertir Estudificar

Estudio primario

No clasificado

Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Autores Pfizer
Registro de estudios clinicaltrials.gov
Año 2006
Enlaces Registro de estudios

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.

Estudio primario

No clasificado

A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis.

Revista Modern rheumatology
Año 2013
Enlaces Pubmed DOI

Este artículo está incluido en 10 Revisiones sistemáticas Revisiones sistemáticas (10 referencias) 1 Síntesis amplia Síntesis amplias (1 referencia)

Cargando información sobre las referencias
OBJECTIVES: The aim of this phase 3, double-blind study was to compare the radiographic and clinical effects of etanercept (ETN) versus methotrexate (MTX) over 52 weeks in Japanese subjects with active rheumatoid arthritis. METHODS: The study population comprised 550 subjects with inadequate response to ≥1 disease-modifying anti-rheumatic drugs who were randomized to treatment groups of ETN 25 mg twice weekly (BIW; n = 182), ETN 10 mg BIW (n = 192), or MTX (≤8.0 mg/week; n = 176). RESULTS: Of the 550 subjects initially enrolled in the three treatment groups, 21.6% discontinued the study; a significantly higher proportion of those who withdrew from the study due to lack of efficacy were in the MTX (21.6%) group compared with the ETN 25 mg (3.3%) and ETN 10 mg (6.8%) groups (P < 0.001). Mean change from baseline in the modified total Sharp score at week 52 (primary endpoint) was significantly lower in the ETN 25 mg [3.33; standard error (SE), 0.73] and ETN 10 mg (5.19; SE 0.93) groups than in the MTX group (9.82; SE 1.16; P < 0.0001 vs. either ETN group). Compared with subjects receiving MTX, significantly higher percentages of subjects treated with ETN 25 and 10 mg achieved American College of Rheumatology (ACR) ACR20 and ACR50 response rates at all time points (P < 0.01). ETN was well-tolerated, with no unexpected safety findings. CONCLUSIONS: ETN 25 mg BIW and ETN 10 mg BIW slowed radiographic progression and improved clinical outcomes more effectively than MTX in this Japanese population.