Toert schreef op 8 oktober 2019 09:43:
Ofwel kijk ik er over, of niet. Maar bij EMA spreekt men in het persbericht over 24 weeks data, bij de Japanners over 52 weken ????Bij EMA staat er :
The MAA for filgotinib is supported by 24-week data from the Phase 3 FINCH clinical trials in which oncedaily treatment with filgotinib achieved improvements in clinical signs and symptoms, achievement of low
disease activity and remission, and inhibition of structural damage for different sub-populations of patients
living with RA. Across the FINCH program, safety data were consistent with previously reported results.
Bij de Japanese staat er :
The FINCH Phase 3 program investigated the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 is a 52-week, randomized, placebo- and adalimumab-controlled trial in combination with methotrexate (MTX) that enrolled 1,759 adult patients with moderately to severely active RA who have had an inadequate response to MTX. The primary endpoint was ACR20 at week 12. The trial included radiographic assessment at weeks 24 and 52. FINCH 2 was a 24-week, randomized, placebo-controlled trial in 449 patients who were receiving conventional disease-modifying anti-rheumatic drugs (cDMARD) and had a prior inadequate response to one or more biological therapies. The primary endpoint was ACR20 at week 12. FINCH 3 is a 52-week, randomized trial in 1,252 MTX-naïve patients to study filgotinib in combination with MTX, as well as monotherapy. The primary endpoint was ACR20 at week 24. Radiographic progression was also assessed.