Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)
26 de octubre de 2020 actualizado por: Galapagos NV
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
Participants 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
- Treatment duration was 24 weeks in total.
- However, at Week 12, participants on placebo who did not achieve a 20% improvement in swollen joint count(SJC66) and tender joint count (TJC68) were re-randomized (automatically via interactive voice/web response [IXRS]) to treatment to receive GLPG0634 100 mg QD or 50 mg BID doses in a blinded fashion, participants on 50 mg QD who had not achieved a 20% improvement in SJC66 and TJC68 were assigned to 100 mg QD and participants on 25 mg BID. who did not achieve a 20% improvement in SJC66 and TJC68 were assigned to 50 mg BID. All continued the study until Week 24.
- Participants in the other groups maintained their randomized treatment until Week 24.
Tipo de estudio
Intervencionista
Inscripción (Actual)
599
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania
- Schlossparkklinik - Akad. Lehrkrankenhaus Charite
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Berlin, Alemania
- Charite Mitte, Rheumatologie Neue Therapien
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Frankfurt, Alemania
- Klinikum Goethe-Universität
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Hamburg, Alemania
- Schwerpunktpraxis fuer Rheumatologie
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Herne, Alemania
- Rheumazentrum Ruhrgebiet
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Buenos Aires, Argentina
- Atencion Integral en Reumatologa
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Buenos Aires, Argentina
- Rheumatology OMI
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Cordoba, Argentina
- Instituto Reumatologico
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Quilmes, Argentina
- Instituto Médico CER
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San Fernando, Argentina
- Instituto de Asistencia Reumatologia Integral
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Tucuman, Argentina
- Centro Medico Privado de Reumatologia
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Camperdown, Australia
- Royal Prince Alfred Hospital
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Clayton, Australia
- Monash Medical Centre
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Daw Park, Australia
- Repatriation General Hospital
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Woolloongabba, Australia
- Princess Alexandra Hospital
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Wien, Austria
- Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
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Plovdiv, Bulgaria
- "Multiprofile Hospital for Active Treatment - Kaspela" LTD
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Ruse, Bulgaria
- MHAT Ruse AD
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Sofia, Bulgaria
- Diagnostic Consultative Center "Sveta Anna" LTD
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Sofia, Bulgaria
- Clinic of Rheumatology MHAT
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Sofia, Bulgaria
- National Transport Hospital "Tsar Boris" III
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Sofia, Bulgaria
- Rheumatology Clinic
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Brussels, Bélgica
- Cliniques Universitaires St-Luc
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Brussels, Bélgica
- Hospital Brugmann
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Hasselt, Bélgica
- Rheuma Instituut
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Kortrijk, Bélgica
- AZ Groeninge
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Leuven, Bélgica
- UZ Leuven
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Liege, Bélgica
- CHU de Liège
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Brno, Chequia
- Revmatologie S.R.O
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Kladno, Chequia
- Ambulance Revmatologie a Interniho Lekarstvi
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Praha-Nusle, Chequia
- Revmatologicka ambulance
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Uherske Hradiste, Chequia
- Medical Plus, S.R.O.
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Zlin, Chequia
- PV-Medical
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Concepcion, Chile
- Hospital Regional "Guillermo Grant Benavente"
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Santiago, Chile
- PROSALUD
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Santiago, Chile
- Someal SA
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Santiago, Chile
- Instituto Terapias Oncologicas Providencia
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Temuco, Chile
- Private office
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Temuco, Chile
- Centro de Investigacion Clínica del Sur Freire
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Barranquilla, Colombia
- Centro Integral de Reumatologia de Caribe
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Barranquilla, Colombia
- Fundación del caribe para la investigación medica Fundación BIOS
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Bogota, Colombia
- Cirei Sas
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Bogota, Colombia
- Idearg S.A.S.
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Bogota, Colombia
- Centro Integral de Reumatologia e Inmunologia SAS
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Bucaramanga, Colombia
- Medicity S.A.S.
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Cali, Colombia
- Clinica de Arthritis Temprana S.A.S.
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Cundinamarca, Colombia
- Preventive Care SAS
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Medellin, Colombia
- Hospital Pablo Tobon Uribe
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Cordoba, España
- Hospital Reina Sofa
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Coruña, España
- Complejo Hospitalario Universitario A Coruña
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Elche, España
- Hospital General Universitario de Elche
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Mostoles, España
- Hospital Universitario de Móstoles
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Sabadell, España
- Consorci Sanitari Parc Tauli
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Sevilla, España
- Hospital Infanta Luisa
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Alabama
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Huntsville, Alabama, Estados Unidos
- Rheumatology Associates of North Alabama, PC
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Arizona
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Gilbert, Arizona, Estados Unidos
- Artho Care, Arthritis Care & Research P.C.
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Phoenix, Arizona, Estados Unidos
- Arizona Arthritis & Rheumatology Research PLLC
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California
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Hemet, California, Estados Unidos
- C.V. Mehta MD Medical Corporation
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La Jolla, California, Estados Unidos
- Center for Innovative TherapyDivision of Rheumatology, UCSD
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Palm Desert, California, Estados Unidos
- Desert Medical Advances
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Victorville, California, Estados Unidos
- Desert Valley Medical Center
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West Hills, California, Estados Unidos
- Infosphere Clinical Research, Inc.
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Florida
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Boca Raton, Florida, Estados Unidos
- RASF Clinical Research Center
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Ormond Beach, Florida, Estados Unidos
- Millennium Research
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Venice, Florida, Estados Unidos
- Lovelace Scientific Resources
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Georgia
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Gainesville, Georgia, Estados Unidos
- Arthritis Center of North GA
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Idaho
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Meridian, Idaho, Estados Unidos
- Idaho Arthritis Center
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Illinois
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Springfield, Illinois, Estados Unidos
- The Arthritis Center
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Kansas
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Wichita, Kansas, Estados Unidos
- Professional Research Network of Kansas
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Maryland
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Frederick, Maryland, Estados Unidos
- Arthritis Treatment Center
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Hagerstown, Maryland, Estados Unidos
- Klein and Associates MD
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Michigan
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Lansing, Michigan, Estados Unidos
- Private Practice
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Minnesota
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Rochester, Minnesota, Estados Unidos
- Mayo Clinic
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North Carolina
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Greenville, North Carolina, Estados Unidos
- Physicians East
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
- Health Research of Oklahoma
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos
- Altoona Center Clinical Research
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Texas
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Austin, Texas, Estados Unidos
- Austin Rheumatology Research PA
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Dallas, Texas, Estados Unidos
- Arthritis Centers of Texas
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Houston, Texas, Estados Unidos
- Pioneer Research Solutions Inc
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Victoria, Texas, Estados Unidos
- Crossroads Clinical Research, LLC
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Washington
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Seattle, Washington, Estados Unidos
- Seattle Rheumatology Associates, PLLC
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West Virginia
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Clarksburg, West Virginia, Estados Unidos
- Mountain State Clinical Research
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Moscow, Federación Rusa
- I.M. Sechenov First Moscow State Medical University
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Moscow, Federación Rusa
- Research Institute of Rheumatology RAMS
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Moscow, Federación Rusa
- State University of Medicine and Dentistry
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Nizhniy Novgorod, Federación Rusa
- City Clinical Hospital 5
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Ryazan, Federación Rusa
- Ryazan State Medical University
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St Petersburg, Federación Rusa
- City Hospital # 26
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Vladimir, Federación Rusa
- Vladimir Reg Clin Hosp
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Strasbourg, Francia
- Hôpitaux Universitaires de Strasbourg
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Guatemala, Guatemala
- Reuma-Centro
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Guatemala City, Guatemala
- Reuma S.A.
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Guatemala City, Guatemala
- Centro Medico
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Guatemala City, Guatemala
- Clinica de Especialidades Medicas
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Guatemala City, Guatemala
- Clinica Medica Especializada en Reumatologia
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Guatemala City, Guatemala
- Clinica Medica
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Balatonfured, Hungría
- DRC
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Budapest, Hungría
- Budai Irgalmasrendi Korhaz
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Budapest, Hungría
- Qualiclinic Ltd
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Budapest, Hungría
- Revita Clinic
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Eger, Hungría
- Markhot Ferenc Korhaz
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Gyula, Hungría
- Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
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Veszprem, Hungría
- Csolnoky Ferenc County Hospital
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Haifa, Israel
- Rambam Medical Center
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Haifa, Israel
- Carmel Medical Center
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Ramat Gan, Israel
- Sheba Medical Center
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Adazi, Letonia
- M&M Centre Ltd.
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Daugavplis, Letonia
- Meda D
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Liepaja, Letonia
- L. Atikes doktorats
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Riga, Letonia
- "Bruninieku" polyclinic
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Riga, Letonia
- Arija's Ancane's Family Doctor
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Chisinau, Moldavia, República de
- IMSP Institutul de Cardiologie
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Guadalajara, México
- Centro de Estudios de Investigacion Basica y Clinica, Sc
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Mexico, México
- Clinstile, S.A. de C.V.
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Mexico, México
- Hospital General de Mexico
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Mexico, México
- Arké Estudios Clínicos
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Monterrey, México
- Accelerium Clinical Research
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Monterrey, México
- Hospital Universitario José E. Gonzalez
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San Luis Potosi, México
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
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Auckland, Nueva Zelanda
- North Shore Hospital
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Hamilton, Nueva Zelanda
- Waikato Hospital
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Timaru, Nueva Zelanda
- Timaru Rheumatology Studies
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Bialystok, Polonia
- NZOZ Osteo-Medic s.c.
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Bytom, Polonia
- Silesiana Centrum Medyczne
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Katowice, Polonia
- Medica Pro Familia sp. z o.o. S.K.A.
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Krakow, Polonia
- Centrum Medyczne Plejady
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Krakow, Polonia
- Nowomed
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Krakow, Polonia
- Nzoz "Dobry Lekarz"
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Skierniewice, Polonia
- NZOZ Przychodnia Lekarska "Eskulap"
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Sroda Wielkopolska, Polonia
- NS ZOZ Medicus Bonus
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Starachowice, Polonia
- Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
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Torun, Polonia
- NZOZ Nasz Lekarz
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Warsaw, Polonia
- AMED Medical Center
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Wroclaw, Polonia
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
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Donetsk, Ucrania
- V. Gusak Institute of Urgent and Recovery Surgery
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Donetsk, Ucrania
- City Hospital #5
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Kharkiv, Ucrania
- City Hospital #8
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Kharkiv, Ucrania
- City Hospital #13
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Kharkiv, Ucrania
- Government Institution
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Kiev, Ucrania
- Central Outpatient Hospital of Deanyanskyy Distric
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Kyiv, Ucrania
- Central regional polyclinic of Pechersk District
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Lutsk, Ucrania
- Municipal Institution Lutsk City Clinical Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
- have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
- Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
- have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.
Exclusion Criteria:
- current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
- current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
- previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: GLPG0634 50 mg una vez al día
Los participantes recibieron cápsulas de GLPG0634 de 50 mg, por vía oral, una vez al día durante las semanas 1 a 12. Los participantes que respondieron (con una mejora de al menos un 20 % en TJC68 y SJC66) siguieron recibiendo 50 mg una vez al día, mientras que los que no respondieron fueron reasignados aleatoriamente a 100 mg una vez al día durante las semanas 13 a 24
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Cápsulas GLPG0634.
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Experimental: GLPG0634 100 mg una vez al día
Los participantes recibieron GLPG0634 cápsulas de 100 mg, por vía oral, QD durante las semanas 1 a 24.
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Cápsulas GLPG0634.
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Experimental: GLPG0634 200 mg una vez al día
Los participantes recibieron GLPG0634 cápsulas de 200 mg, por vía oral, QD durante las semanas 1 a 24.
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Cápsulas GLPG0634.
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Comparador de placebos: Placebo
Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.
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Cápsulas de placebo.
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Experimental: GLPG0634 25 mg BID
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
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Cápsulas GLPG0634.
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Experimental: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
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Cápsulas GLPG0634.
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Experimental: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
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Cápsulas GLPG0634.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Porcentaje de participantes que lograron una respuesta del American College of Rheumatology (ACR) 20 en la semana 12
Periodo de tiempo: Semana 12
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La respuesta del American College of Rheumatology (ACR) es una medida de mejora en múltiples criterios de evaluación de enfermedades.
La respuesta ACR20 se define como: 1) ≥ 20 % de mejora desde el inicio en SJC66, y 2) ≥ 20 % de mejora desde el inicio en TJC68 tierno, y 3) ≥ 20 % de mejora desde el inicio en al menos 3 de los siguientes 5 elementos: 1. Escala analógica visual (EVA) del dolor (tomada del Cuestionario de evaluación de la salud - Índice de discapacidad [HAQ-DI]), 2. Evaluación global de la actividad de la enfermedad del paciente, EVA, 3. Evaluación global de la actividad de la enfermedad del médico, 4. HAQ total -puntuación DI, y 5. PCR.
Se utilizó la imputación de no respondedor (es decir, para imputar una respuesta faltante, se supuso que el participante no respondía).
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Semana 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Porcentaje de participantes que lograron una respuesta ACR20 en la semana 24
Periodo de tiempo: Semana 24
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La respuesta ACR20 se definió como: 1) ≥ 20 % de mejora desde el inicio en SJC66, y 2) ≥ 20 % de mejora desde el inicio en TJC68, y 3) ≥ 20 % de mejora desde el inicio en al menos 3 de los siguientes 5 elementos: 1. EVA del dolor (tomado del HAQ-DI), 2. Evaluación global del paciente de la actividad de la enfermedad EVA, 3. Evaluación global del médico de la actividad de la enfermedad EVA, 4. Puntuación total del HAQ-DI y 5. PCR.
Se utilizó la imputación de no respondedor.
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Semana 24
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Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Periodo de tiempo: Weeks 1, 2, 4, 8, 12, and 24
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ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Total HAQ-DI score 5. CRP.
Non-responder imputation was used.
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Weeks 1, 2, 4, 8, 12, and 24
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Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
Periodo de tiempo: Weeks 1, 2, 4, 8, 12, and 24
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ACR70 response: 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP.
Non-responder imputation was used.
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Weeks 1, 2, 4, 8, 12, and 24
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ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
Periodo de tiempo: Weeks 1, 2, 4, 8, 12, and 24
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The ACR-N is the smallest percentage improvement in swollen and tender joints and the median of the remaining 5 core parameters, and is expected to be more sensitive to change than the ACR20, ACR50 or ACR70.
It is a number varying between 0 and 100, with higher numbers indicating less severity of symptoms.
Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
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Weeks 1, 2, 4, 8, 12, and 24
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Percentage of Participants With Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) Response at Weeks 1, 2, 4, 8, 12, and 24
Periodo de tiempo: Weeks 1, 2, 4, 8, 12, and 24
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DAS28 (CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None = Actual DAS28 (CRP) ≤ 3.2, > 3.2 to ≤ 5.1, or > 5.1 AND Improvement in DAS28 (CRP) from baseline ≤ 6.0 or > 0.6 to ≤ 1.2; Moderate = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28 (CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28 (CRP) from baseline > 1.2, or Actual DAS28 (CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2; Good = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 1.2.
LOCF algorithm was used.
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Weeks 1, 2, 4, 8, 12, and 24
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Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
Periodo de tiempo: Weeks 2, 4, 8, 12, and 24
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A participant's disease activity status can be defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and Patient Global Assessment of Disease Activity (cm) are all ≤ 1. Non-responder imputation was used.
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Weeks 2, 4, 8, 12, and 24
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Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
Periodo de tiempo: Baseline and Weeks 1, 2, 4, 8, 12, and 24
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The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), Physician's Global Assessment of Disease Activity (in cm), and CRP (mg/dL). The SDAI was categorized as follows: • High disease activity: SDAI > 26 • Moderate disease activity: 11 to 26 • Low disease activity: 3.3 to 11 • Remission: ≤ 3.3. LOCF algorithm was used. The SDAI total score ranges from 0 to approximately 86. |
Baseline and Weeks 1, 2, 4, 8, 12, and 24
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
Periodo de tiempo: Baseline and Weeks 1, 2, 4, 8, 12, and 24
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The CDAI is the SDAI modified to exclude CRP and is the sum of the 4 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), and Physician's Global Assessment of Disease Activity (in cm).
The CDAI was be categorized as follows: • High disease activity: > 22 • Moderate disease activity: 10 to 22 • Mild disease activity: 2.8 to 10 • Remission: ≤ 2.8.
LOCF algorithm was used.
The CDAI total score ranges from 0 to approximately 76.
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Baseline and Weeks 1, 2, 4, 8, 12, and 24
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Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24
Periodo de tiempo: Baseline and Weeks 4, 12, and 24
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FACIT-Fatigue scale is a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated that are scored reversely), the greater the fatigue.
The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating a better quality of life.
LOCF algorithm was used.
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Baseline and Weeks 4, 12, and 24
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Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
Periodo de tiempo: Baseline and Weeks 4, 12, and 24
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The SF-36 is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).
Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.
Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
LOCF algorithm was used.
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Baseline and Weeks 4, 12, and 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2022 Oct 7. doi: 10.1007/s40744-022-00494-1. Online ahead of print.
- Tarrant JM, Galien R, Li W, Goyal L, Pan Y, Hawtin R, Zhang W, Van der Aa A, Taylor PC. Filgotinib, a JAK1 Inhibitor, Modulates Disease-Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials. Rheumatol Ther. 2020 Mar;7(1):173-190. doi: 10.1007/s40744-019-00192-5. Epub 2020 Jan 7.
- Westhovens R, Taylor PC, Alten R, Pavlova D, Enriquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017 Jun;76(6):998-1008. doi: 10.1136/annrheumdis-2016-210104. Epub 2016 Dec 19.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de julio de 2013
Finalización primaria (Actual)
18 de febrero de 2015
Finalización del estudio (Actual)
14 de mayo de 2015
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2013
Primero enviado que cumplió con los criterios de control de calidad
27 de junio de 2013
Publicado por primera vez (Estimar)
28 de junio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GLPG0634-CL-203 (DARWIN1)
- 2012-003635-31 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .