A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

CompletadoFase 3ClinicalTrials.gov

ID: NCT02889796Tipo: INTERVENTIONALInicio: 30 de ago de 2016Fin estimado: 20 de jun de 2019

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of rheumatoid arthritis (RA) \[2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria\] , and are ACR functional class I-III.
Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
Ongoing treatment with a stable dose of MTX

Criterios de exclusión

Previous treatment with any janus kinase (JAK) inhibitor

Intervenciones

drug

Filgotinib

200 mg or 100 mg tablet(s) administered orally once daily

drug

Placebo to match filgotinib

Tablet(s) administered orally once daily

drug

Adalimumab

40 mg administered via subcutaneous injection once every two weeks

drug

Placebo to match adalimumab

Administered via subcutaneous injection once every two weeks

drug

MTX

Commercially sourced tablet(s) administered orally

Ubicaciones

Buenos Aires, Argentina

Caba, Argentina

Mendoza, Argentina

Quilmes, Argentina

San Fernando, Argentina

San Juan, Argentina

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalGilead Sciences

ColaboradorGalapagos NV

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