A Randomized, Double-blind, Placebo-controlled, Multicent... | EligiMed

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

CompletadoFase 3ClinicalTrials.gov

ID: NCT02873936Tipo: INTERVENTIONALInicio: 27 de jul de 2016Fin estimado: 26 de jun de 2018

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 RA (2010 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria for RA), 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 screening and Day 1
Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance

Criterios de exclusión

Previous treatment with any janus kinase (JAK) inhibitor

Intervenciones

drug

Filgotinib

Tablet(s) administered orally once daily

drug

Placebo to match filgotinib

Tablet(s) administered orally once daily

drug

csDMARDs

csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)

Ubicaciones

Buenos Aires, Argentina

Caba, Argentina

San Juan, Argentina

Patrocinadores

PrincipalGilead Sciences

ColaboradorGalapagos NV

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