Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)
2020년 10월 26일 업데이트: 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.
연구 개요
상세 설명
- 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.
연구 유형
중재적
등록 (실제)
599
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guatemala, 과테말라
- Reuma-Centro
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Guatemala City, 과테말라
- Reuma S.A.
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Guatemala City, 과테말라
- Centro Medico
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Guatemala City, 과테말라
- Clinica de Especialidades Medicas
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Guatemala City, 과테말라
- Clinica Medica Especializada en Reumatologia
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Guatemala City, 과테말라
- Clinica Medica
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Auckland, 뉴질랜드
- North Shore Hospital
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Hamilton, 뉴질랜드
- Waikato Hospital
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Timaru, 뉴질랜드
- Timaru Rheumatology Studies
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Berlin, 독일
- Schlossparkklinik - Akad. Lehrkrankenhaus Charite
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Berlin, 독일
- Charite Mitte, Rheumatologie Neue Therapien
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Frankfurt, 독일
- Klinikum Goethe-Universität
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Hamburg, 독일
- Schwerpunktpraxis fuer Rheumatologie
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Herne, 독일
- Rheumazentrum Ruhrgebiet
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Adazi, 라트비아
- M&M Centre Ltd.
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Daugavplis, 라트비아
- Meda D
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Liepaja, 라트비아
- L. Atikes doktorats
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Riga, 라트비아
- "Bruninieku" polyclinic
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Riga, 라트비아
- Arija's Ancane's Family Doctor
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Moscow, 러시아 연방
- I.M. Sechenov First Moscow State Medical University
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Moscow, 러시아 연방
- Research Institute of Rheumatology RAMS
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Moscow, 러시아 연방
- State University of Medicine and Dentistry
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Nizhniy Novgorod, 러시아 연방
- City Clinical Hospital 5
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Ryazan, 러시아 연방
- Ryazan State Medical University
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St Petersburg, 러시아 연방
- City Hospital # 26
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Vladimir, 러시아 연방
- Vladimir Reg Clin Hosp
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Guadalajara, 멕시코
- Centro de Estudios de Investigacion Basica y Clinica, Sc
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Mexico, 멕시코
- Clinstile, S.A. de C.V.
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Mexico, 멕시코
- Hospital General de Mexico
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Mexico, 멕시코
- Arké Estudios Clínicos
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Monterrey, 멕시코
- Accelerium Clinical Research
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Monterrey, 멕시코
- Hospital Universitario José E. Gonzalez
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San Luis Potosi, 멕시코
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
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Chisinau, 몰도바 공화국
- IMSP Institutul de Cardiologie
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Alabama
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Huntsville, Alabama, 미국
- Rheumatology Associates of North Alabama, PC
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Arizona
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Gilbert, Arizona, 미국
- Artho Care, Arthritis Care & Research P.C.
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Phoenix, Arizona, 미국
- Arizona Arthritis & Rheumatology Research PLLC
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California
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Hemet, California, 미국
- C.V. Mehta MD Medical Corporation
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La Jolla, California, 미국
- Center for Innovative TherapyDivision of Rheumatology, UCSD
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Palm Desert, California, 미국
- Desert Medical Advances
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Victorville, California, 미국
- Desert Valley Medical Center
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West Hills, California, 미국
- Infosphere Clinical Research, Inc.
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Florida
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Boca Raton, Florida, 미국
- RASF Clinical Research Center
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Ormond Beach, Florida, 미국
- Millennium Research
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Venice, Florida, 미국
- Lovelace Scientific Resources
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Georgia
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Gainesville, Georgia, 미국
- Arthritis Center of North GA
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Idaho
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Meridian, Idaho, 미국
- Idaho Arthritis Center
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Illinois
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Springfield, Illinois, 미국
- The Arthritis Center
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Kansas
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Wichita, Kansas, 미국
- Professional Research Network of Kansas
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Maryland
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Frederick, Maryland, 미국
- Arthritis Treatment Center
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Hagerstown, Maryland, 미국
- Klein and Associates MD
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Michigan
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Lansing, Michigan, 미국
- Private practice
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Minnesota
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Rochester, Minnesota, 미국
- Mayo Clinic
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North Carolina
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Greenville, North Carolina, 미국
- Physicians East
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Oklahoma
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Oklahoma City, Oklahoma, 미국
- Health Research of Oklahoma
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Pennsylvania
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Duncansville, Pennsylvania, 미국
- Altoona Center Clinical Research
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Texas
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Austin, Texas, 미국
- Austin Rheumatology Research PA
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Dallas, Texas, 미국
- Arthritis Centers Of Texas
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Houston, Texas, 미국
- Pioneer Research Solutions Inc
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Victoria, Texas, 미국
- Crossroads Clinical Research, LLC
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Washington
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Seattle, Washington, 미국
- Seattle Rheumatology Associates, PLLC
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West Virginia
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Clarksburg, West Virginia, 미국
- Mountain State Clinical Research
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Brussels, 벨기에
- Cliniques Universitaires St-Luc
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Brussels, 벨기에
- Hospital Brugmann
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Hasselt, 벨기에
- Rheuma Instituut
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Kortrijk, 벨기에
- AZ Groeninge
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Leuven, 벨기에
- UZ Leuven
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Liege, 벨기에
- CHU de Liege
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Plovdiv, 불가리아
- "Multiprofile Hospital for Active Treatment - Kaspela" LTD
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Ruse, 불가리아
- MHAT Ruse AD
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Sofia, 불가리아
- Diagnostic Consultative Center "Sveta Anna" LTD
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Sofia, 불가리아
- Clinic of Rheumatology MHAT
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Sofia, 불가리아
- National Transport Hospital "Tsar Boris" III
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Sofia, 불가리아
- Rheumatology Clinic
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Cordoba, 스페인
- Hospital Reina Sofa
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Coruña, 스페인
- Complejo Hospitalario Universitario A Coruña
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Elche, 스페인
- Hospital General Universitario de Elche
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Mostoles, 스페인
- Hospital Universitario de Móstoles
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Sabadell, 스페인
- Consorci Sanitari Parc Taulí
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Sevilla, 스페인
- Hospital Infanta Luisa
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Buenos Aires, 아르헨티나
- Atencion Integral en Reumatologa
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Buenos Aires, 아르헨티나
- Rheumatology OMI
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Cordoba, 아르헨티나
- Instituto Reumatologico
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Quilmes, 아르헨티나
- Instituto Medico CER
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San Fernando, 아르헨티나
- Instituto de Asistencia Reumatologia Integral
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Tucuman, 아르헨티나
- Centro Medico Privado de Reumatologia
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Wien, 오스트리아
- Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
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Donetsk, 우크라이나
- V. Gusak Institute of Urgent and Recovery Surgery
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Donetsk, 우크라이나
- City Hospital #5
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Kharkiv, 우크라이나
- City Hospital #8
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Kharkiv, 우크라이나
- City Hospital #13
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Kharkiv, 우크라이나
- Government Institution
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Kiev, 우크라이나
- Central Outpatient Hospital of Deanyanskyy Distric
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Kyiv, 우크라이나
- Central regional polyclinic of Pechersk District
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Lutsk, 우크라이나
- Municipal Institution Lutsk City Clinical Hospital
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Haifa, 이스라엘
- Rambam Medical Center
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Haifa, 이스라엘
- Carmel Medical Center
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Ramat Gan, 이스라엘
- Sheba Medical Center
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Brno, 체코
- Revmatologie S.R.O
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Kladno, 체코
- Ambulance Revmatologie a Interniho Lekarstvi
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Praha-Nusle, 체코
- Revmatologicka ambulance
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Uherske Hradiste, 체코
- Medical Plus, S.R.O.
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Zlin, 체코
- PV-Medical
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Concepcion, 칠레
- Hospital Regional "Guillermo Grant Benavente"
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Santiago, 칠레
- Prosalud
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Santiago, 칠레
- Someal SA
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Santiago, 칠레
- Instituto Terapias Oncologicas Providencia
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Temuco, 칠레
- Private Office
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Temuco, 칠레
- Centro de Investigacion Clínica del Sur Freire
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Barranquilla, 콜롬비아
- Centro Integral de Reumatologia de Caribe
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Barranquilla, 콜롬비아
- Fundación del caribe para la investigación medica Fundación BIOS
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Bogota, 콜롬비아
- Cirei Sas
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Bogota, 콜롬비아
- Idearg S.A.S.
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Bogota, 콜롬비아
- Centro Integral de Reumatologia e Inmunologia SAS
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Bucaramanga, 콜롬비아
- Medicity S.A.S.
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Cali, 콜롬비아
- Clinica de Arthritis Temprana S.A.S.
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Cundinamarca, 콜롬비아
- Preventive Care SAS
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Medellin, 콜롬비아
- Hospital Pablo Tobón Uribe
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Bialystok, 폴란드
- NZOZ Osteo-Medic s.c.
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Bytom, 폴란드
- Silesiana Centrum Medyczne
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Katowice, 폴란드
- Medica Pro Familia Sp. z o.o. S.K.A.
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Krakow, 폴란드
- Centrum Medyczne Plejady
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Krakow, 폴란드
- Nowomed
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Krakow, 폴란드
- Nzoz "Dobry Lekarz"
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Skierniewice, 폴란드
- NZOZ Przychodnia Lekarska "Eskulap"
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Sroda Wielkopolska, 폴란드
- NS ZOZ Medicus Bonus
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Starachowice, 폴란드
- Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
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Torun, 폴란드
- NZOZ Nasz Lekarz
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Warsaw, 폴란드
- AMED Medical Center
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Wroclaw, 폴란드
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
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Strasbourg, 프랑스
- Hôpitaux Universitaires de Strasbourg
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Balatonfured, 헝가리
- DRC
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Budapest, 헝가리
- Budai Irgalmasrendi Korhaz
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Budapest, 헝가리
- Qualiclinic Ltd
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Budapest, 헝가리
- Revita Clinic
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Eger, 헝가리
- Markhot Ferenc Korhaz
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Gyula, 헝가리
- Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
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Veszprem, 헝가리
- Csolnoky Ferenc County Hospital
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Camperdown, 호주
- Royal Prince Alfred Hospital
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Clayton, 호주
- Monash Medical Centre
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Daw Park, 호주
- Repatriation General Hospital
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Woolloongabba, 호주
- Princess Alexandra Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: GLPG0634 50mg QD
참가자는 1주에서 12주 동안 GLPG0634 50mg 캡슐을 경구 QD로 받았습니다. 반응자(TJC68 및 SJC66에서 최소 20% 개선됨)인 참가자는 50mg QD를 유지한 반면 비반응자는 13주 동안 100mg QD로 다시 무작위 배정되었습니다. 24.
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GLPG0634 캡슐.
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실험적: GLPG0634 100mg QD
참가자는 1주에서 24주 동안 GLPG0634 100mg 캡슐을 경구로 QD 받았습니다.
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GLPG0634 캡슐.
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실험적: GLPG0634 200mg QD
참가자는 1주에서 24주 동안 GLPG0634 200mg 캡슐을 경구로 QD 받았습니다.
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GLPG0634 캡슐.
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위약 비교기: 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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위약 캡슐.
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실험적: 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 캡슐.
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실험적: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
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GLPG0634 캡슐.
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실험적: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
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GLPG0634 캡슐.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
12주차에 American College of Rheumatology(ACR) 20 반응을 달성한 참가자의 비율
기간: 12주차
|
American College of Rheumatology(ACR) 반응은 여러 질병 평가 기준의 개선을 측정한 것입니다.
ACR20 반응은 1) SJC66에서 베이스라인 대비 ≥ 20% 개선, 2) 입찰 TJC68에서 베이스라인 대비 ≥ 20% 개선, 3) 다음 5개 항목 중 3개 이상에서 베이스라인 대비 ≥ 20% 개선으로 정의됩니다. 1. 통증 시각적 아날로그 척도(VAS)(건강 평가 설문지 - 장애 지수[HAQ-DI]에서 가져옴), 2. 질병 활동에 대한 환자의 전반적인 평가 VAS, 3. 질병 활동에 대한 의사의 전반적인 평가 VAS, 4. 전체 HAQ -DI 점수 및 5. CRP.
비응답자 전가가 사용되었습니다(즉, 누락된 응답을 전가하기 위해 참가자는 비응답자로 간주됨).
|
12주차
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
24주차에 ACR20 반응을 달성한 참가자의 비율
기간: 24주차
|
ACR20 반응은 1) SJC66에서 베이스라인 대비 ≥ 20% 개선, 2) TJC68에서 베이스라인 대비 ≥ 20% 개선, 3) 다음 5개 항목 중 최소 3개 항목에서 베이스라인 대비 ≥ 20% 개선으로 정의되었습니다. 1. 통증 VAS(HAQ-DI에서 가져옴), 2. 질병 활동에 대한 환자의 전반적인 평가 VAS, 3. 질병 활동에 대한 의사의 전반적인 평가 VAS, 4. 전체 HAQ-DI 점수 및 5. CRP.
비 응답자 전가가 사용되었습니다.
|
24주차
|
|
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2013년 7월 17일
기본 완료 (실제)
2015년 2월 18일
연구 완료 (실제)
2015년 5월 14일
연구 등록 날짜
최초 제출
2013년 6월 26일
QC 기준을 충족하는 최초 제출
2013년 6월 27일
처음 게시됨 (추정)
2013년 6월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 10월 26일
마지막으로 확인됨
2020년 10월 1일
추가 정보
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