Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)
26 ottobre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
- 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 di studio
Interventistico
Iscrizione (Effettivo)
599
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Brussels, Belgio
- Cliniques Universitaires St-Luc
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Brussels, Belgio
- Hospital Brugmann
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Hasselt, Belgio
- Rheuma Instituut
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Kortrijk, Belgio
- AZ Groeninge
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Leuven, Belgio
- UZ Leuven
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Liege, Belgio
- CHU de Liège
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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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Brno, Cechia
- Revmatologie S.R.O
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Kladno, Cechia
- Ambulance Revmatologie a Interniho Lekarstvi
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Praha-Nusle, Cechia
- Revmatologicka ambulance
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Uherske Hradiste, Cechia
- MEDICAL PLUS, s.r.o.
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Zlin, Cechia
- 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 Tobón Uribe
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Moscow, Federazione Russa
- I.M. Sechenov First Moscow State Medical University
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Moscow, Federazione Russa
- Research Institute of Rheumatology RAMS
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Moscow, Federazione Russa
- State University of Medicine and Dentistry
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Nizhniy Novgorod, Federazione Russa
- City Clinical Hospital 5
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Ryazan, Federazione Russa
- Ryazan State Medical University
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St Petersburg, Federazione Russa
- City Hospital # 26
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Vladimir, Federazione Russa
- Vladimir Reg Clin Hosp
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Strasbourg, Francia
- Hopitaux Universitaires de Strasbourg
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Berlin, Germania
- Schlossparkklinik - Akad. Lehrkrankenhaus Charite
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Berlin, Germania
- Charite Mitte, Rheumatologie Neue Therapien
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Frankfurt, Germania
- Klinikum Goethe-Universität
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Hamburg, Germania
- Schwerpunktpraxis fuer Rheumatologie
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Herne, Germania
- Rheumazentrum Ruhrgebiet
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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 Médico
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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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Haifa, Israele
- Rambam Medical Center
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Haifa, Israele
- Carmel Medical Center
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Ramat Gan, Israele
- Sheba Medical Center
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Adazi, Lettonia
- M&M Centre Ltd.
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Daugavplis, Lettonia
- Meda D
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Liepaja, Lettonia
- L. Atikes doktorats
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Riga, Lettonia
- "Bruninieku" polyclinic
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Riga, Lettonia
- Arija's Ancane's Family Doctor
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Guadalajara, Messico
- Centro de Estudios de Investigacion Basica y Clinica, Sc
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Mexico, Messico
- Clinstile, S.A. de C.V.
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Mexico, Messico
- Hospital General de Mexico
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Mexico, Messico
- Arké Estudios Clínicos
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Monterrey, Messico
- Accelerium Clinical Research
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Monterrey, Messico
- Hospital Universitario José E. Gonzalez
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San Luis Potosi, Messico
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
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Chisinau, Moldavia, Repubblica di
- IMSP Institutul de Cardiologie
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Auckland, Nuova Zelanda
- North Shore Hospital
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Hamilton, Nuova Zelanda
- Waikato Hospital
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Timaru, Nuova 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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Cordoba, Spagna
- Hospital Reina Sofa
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Coruña, Spagna
- Complejo Hospitalario Universitario A Coruna
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Elche, Spagna
- Hospital General Universitario de Elche
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Mostoles, Spagna
- Hospital Universitario de Móstoles
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Sabadell, Spagna
- Consorci Sanitari Parc Taulí
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Sevilla, Spagna
- Hospital Infanta Luisa
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Alabama
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Huntsville, Alabama, Stati Uniti
- Rheumatology Associates of North Alabama, PC
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Arizona
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Gilbert, Arizona, Stati Uniti
- Artho Care, Arthritis Care & Research P.C.
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Phoenix, Arizona, Stati Uniti
- Arizona Arthritis & Rheumatology Research PLLC
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California
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Hemet, California, Stati Uniti
- C.V. Mehta MD Medical Corporation
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La Jolla, California, Stati Uniti
- Center for Innovative TherapyDivision of Rheumatology, UCSD
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Palm Desert, California, Stati Uniti
- Desert Medical Advances
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Victorville, California, Stati Uniti
- Desert Valley Medical Center
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West Hills, California, Stati Uniti
- Infosphere Clinical Research, Inc.
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Florida
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Boca Raton, Florida, Stati Uniti
- RASF Clinical Research Center
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Ormond Beach, Florida, Stati Uniti
- Millennium Research
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Venice, Florida, Stati Uniti
- Lovelace Scientific Resources
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Georgia
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Gainesville, Georgia, Stati Uniti
- Arthritis Center of North GA
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Idaho
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Meridian, Idaho, Stati Uniti
- Idaho Arthritis Center
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Illinois
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Springfield, Illinois, Stati Uniti
- The Arthritis Center
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Kansas
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Wichita, Kansas, Stati Uniti
- Professional Research Network of Kansas
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Maryland
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Frederick, Maryland, Stati Uniti
- Arthritis Treatment Center
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Hagerstown, Maryland, Stati Uniti
- Klein and Associates MD
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Michigan
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Lansing, Michigan, Stati Uniti
- Private Practice
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Minnesota
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Rochester, Minnesota, Stati Uniti
- Mayo Clinic
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North Carolina
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Greenville, North Carolina, Stati Uniti
- Physicians East
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti
- Health Research of Oklahoma
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Pennsylvania
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Duncansville, Pennsylvania, Stati Uniti
- Altoona Center Clinical Research
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Texas
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Austin, Texas, Stati Uniti
- Austin Rheumatology Research PA
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Dallas, Texas, Stati Uniti
- Arthritis Centers Of Texas
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Houston, Texas, Stati Uniti
- Pioneer Research Solutions Inc
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Victoria, Texas, Stati Uniti
- Crossroads Clinical Research, LLC
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Washington
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Seattle, Washington, Stati Uniti
- Seattle Rheumatology Associates, PLLC
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West Virginia
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Clarksburg, West Virginia, Stati Uniti
- Mountain State Clinical Research
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Donetsk, Ucraina
- V. Gusak Institute of Urgent and Recovery Surgery
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Donetsk, Ucraina
- City Hospital #5
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Kharkiv, Ucraina
- City Hospital #8
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Kharkiv, Ucraina
- City Hospital #13
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Kharkiv, Ucraina
- Government Institution
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Kiev, Ucraina
- Central Outpatient Hospital of Deanyanskyy Distric
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Kyiv, Ucraina
- Central regional polyclinic of Pechersk District
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Lutsk, Ucraina
- Municipal Institution Lutsk City Clinical Hospital
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Balatonfured, Ungheria
- DRC
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Budapest, Ungheria
- Budai Irgalmasrendi Kórház
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Budapest, Ungheria
- Qualiclinic Ltd
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Budapest, Ungheria
- Revita Clinic
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Eger, Ungheria
- Markhot Ferenc Korhaz
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Gyula, Ungheria
- Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
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Veszprem, Ungheria
- Csolnoky Ferenc County Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: GLPG0634 50 mg QD
I partecipanti hanno ricevuto GLPG0634 capsule da 50 mg, per via orale, QD durante le settimane da 1 a 12. I partecipanti che hanno risposto (con un miglioramento di almeno il 20% su TJC68 e SJC66) sono rimasti su 50 mg QD mentre i non responder sono stati nuovamente randomizzati a 100 mg QD durante le settimane 13 a 24.
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GLPG0634 capsule.
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Sperimentale: GLPG0634 100 mg QD
I partecipanti hanno ricevuto GLPG0634 capsule da 100 mg, per via orale, QD durante le settimane da 1 a 24.
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GLPG0634 capsule.
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Sperimentale: GLPG0634 200 mg QD
I partecipanti hanno ricevuto GLPG0634 capsule da 200 mg, per via orale, QD durante le settimane da 1 a 24.
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GLPG0634 capsule.
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Comparatore placebo: 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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Capsule placebo.
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Sperimentale: 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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GLPG0634 capsule.
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Sperimentale: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
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GLPG0634 capsule.
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Sperimentale: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
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GLPG0634 capsule.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentuale di partecipanti che hanno ottenuto una risposta 20 dell'American College of Rheumatology (ACR) alla settimana 12
Lasso di tempo: Settimana 12
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La risposta dell'American College of Rheumatology (ACR) è una misura del miglioramento in più criteri di valutazione della malattia.
La risposta ACR20 è definita come: 1) miglioramento ≥ 20% rispetto al basale in SJC66 e 2) miglioramento ≥ 20% rispetto al basale in TJC68 dolente e 3) miglioramento ≥ 20% rispetto al basale in almeno 3 dei seguenti 5 elementi: 1. Scala analogica visiva del dolore (VAS) (tratta dal questionario di valutazione della salute - Indice di disabilità [HAQ-DI]), 2. Valutazione globale del paziente dell'attività della malattia VAS, 3. Valutazione globale del medico dell'attività della malattia VAS, 4. HAQ totale -DI punteggio e 5. CRP.
È stata utilizzata l'attribuzione di non-responder (cioè, per imputare una risposta mancante, si presumeva che il partecipante fosse un non-responder).
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Settimana 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentuale di partecipanti che hanno ottenuto una risposta ACR20 alla settimana 24
Lasso di tempo: Settimana 24
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La risposta ACR20 è stata definita come: 1) miglioramento ≥ 20% rispetto al basale in SJC66 e 2) miglioramento ≥ 20% rispetto al basale in TJC68 e 3) miglioramento ≥ 20% rispetto al basale in almeno 3 dei seguenti 5 elementi: 1. Dolore VAS (preso dall'HAQ-DI), 2. Valutazione globale dell'attività della malattia del paziente VAS, 3. Valutazione globale dell'attività della malattia del medico VAS, 4. Punteggio HAQ-DI totale e 5. CRP.
È stata utilizzata l'attribuzione di non-responder.
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Settimana 24
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Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Lasso di tempo: Weeks 1, 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Weeks 1, 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Weeks 1, 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Weeks 1, 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Weeks 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Baseline and Weeks 1, 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Baseline and Weeks 1, 2, 4, 8, 12, and 24
|
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
Lasso di tempo: Baseline and Weeks 4, 12, and 24
|
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
Lasso di tempo: Baseline and Weeks 4, 12, and 24
|
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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 luglio 2013
Completamento primario (Effettivo)
18 febbraio 2015
Completamento dello studio (Effettivo)
14 maggio 2015
Date di iscrizione allo studio
Primo inviato
26 giugno 2013
Primo inviato che soddisfa i criteri di controllo qualità
27 giugno 2013
Primo Inserito (Stima)
28 giugno 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 novembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GLPG0634-CL-203 (DARWIN1)
- 2012-003635-31 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .