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GLPG0634 · DARWIN1

Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

Ensayo de Lakefront Biotherapeutics NV en Artritis reumatoide.

Más ensayos de: Artritis reumatoide.

Fase

Fase 2

Estado

Completado

Participantes

599

previstos

Centros

142

Fin del objetivo primario

feb 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2013.

Qué mide

Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 (del registro, en inglés) (semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroParticipants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram \[mg\], 100 mg and 200 mg daily -, each evaluated as once daily \[QD\] and twice daily \[BID\] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

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Ficha completa en ClinicalTrials.gov (NCT01888874), actualizada en oct 2020.