GLPG0634

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Ensayo de Lakefront Biotherapeutics NV en Artritis reumatoide.

Fase: Fase 2
Estado: Completado
Participantes: 287
Centros: 82
Fin del objetivo primario: mar 2015

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 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 registro* Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) 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 of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.

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Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01894516), actualizada en nov 2020.