Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)
26. oktober 2020 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
- 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.
Studietype
Intervensjonell
Registrering (Faktiske)
599
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Buenos Aires, Argentina
- Atencion Integral en Reumatologa
-
Buenos Aires, Argentina
- Rheumatology OMI
-
Cordoba, Argentina
- Instituto Reumatologico
-
Quilmes, Argentina
- Instituto Médico Cer
-
San Fernando, Argentina
- Instituto de Asistencia Reumatologia Integral
-
Tucuman, Argentina
- Centro Medico Privado de Reumatologia
-
-
-
-
-
Camperdown, Australia
- Royal Prince Alfred Hospital
-
Clayton, Australia
- Monash Medical Centre
-
Daw Park, Australia
- Repatriation General Hospital
-
Woolloongabba, Australia
- Princess Alexandra Hospital
-
-
-
-
-
Brussels, Belgia
- Cliniques Universitaires St-Luc
-
Brussels, Belgia
- Hospital Brugmann
-
Hasselt, Belgia
- Rheuma Instituut
-
Kortrijk, Belgia
- AZ Groeninge
-
Leuven, Belgia
- UZ Leuven
-
Liege, Belgia
- CHU de Liege
-
-
-
-
-
Plovdiv, Bulgaria
- "Multiprofile Hospital for Active Treatment - Kaspela" LTD
-
Ruse, Bulgaria
- MHAT Ruse AD
-
Sofia, Bulgaria
- Diagnostic Consultative Center "Sveta Anna" LTD
-
Sofia, Bulgaria
- Clinic of Rheumatology MHAT
-
Sofia, Bulgaria
- National Transport Hospital "Tsar Boris" III
-
Sofia, Bulgaria
- Rheumatology Clinic
-
-
-
-
-
Concepcion, Chile
- Hospital Regional "Guillermo Grant Benavente"
-
Santiago, Chile
- Prosalud
-
Santiago, Chile
- Someal SA
-
Santiago, Chile
- Instituto Terapias Oncologicas Providencia
-
Temuco, Chile
- Private Office
-
Temuco, Chile
- Centro de Investigacion Clínica del Sur Freire
-
-
-
-
-
Barranquilla, Colombia
- Centro Integral de Reumatologia de Caribe
-
Barranquilla, Colombia
- Fundación del caribe para la investigación medica Fundación BIOS
-
Bogota, Colombia
- Cirei Sas
-
Bogota, Colombia
- Idearg S.A.S.
-
Bogota, Colombia
- Centro Integral de Reumatologia e Inmunologia SAS
-
Bucaramanga, Colombia
- Medicity S.A.S.
-
Cali, Colombia
- Clinica de Arthritis Temprana S.A.S.
-
Cundinamarca, Colombia
- Preventive Care SAS
-
Medellin, Colombia
- Hospital Pablo Tobon Uribe
-
-
-
-
-
Moscow, Den russiske føderasjonen
- I.M. Sechenov First Moscow State Medical University
-
Moscow, Den russiske føderasjonen
- Research Institute of Rheumatology RAMS
-
Moscow, Den russiske føderasjonen
- State University of Medicine and Dentistry
-
Nizhniy Novgorod, Den russiske føderasjonen
- City Clinical Hospital 5
-
Ryazan, Den russiske føderasjonen
- Ryazan State Medical University
-
St Petersburg, Den russiske føderasjonen
- City Hospital # 26
-
Vladimir, Den russiske føderasjonen
- Vladimir Reg Clin Hosp
-
-
-
-
Alabama
-
Huntsville, Alabama, Forente stater
- Rheumatology Associates of North Alabama, PC
-
-
Arizona
-
Gilbert, Arizona, Forente stater
- Artho Care, Arthritis Care & Research P.C.
-
Phoenix, Arizona, Forente stater
- Arizona Arthritis & Rheumatology Research PLLC
-
-
California
-
Hemet, California, Forente stater
- C.V. Mehta MD Medical Corporation
-
La Jolla, California, Forente stater
- Center for Innovative TherapyDivision of Rheumatology, UCSD
-
Palm Desert, California, Forente stater
- Desert Medical Advances
-
Victorville, California, Forente stater
- Desert Valley Medical Center
-
West Hills, California, Forente stater
- Infosphere Clinical Research, Inc.
-
-
Florida
-
Boca Raton, Florida, Forente stater
- RASF Clinical Research Center
-
Ormond Beach, Florida, Forente stater
- Millennium Research
-
Venice, Florida, Forente stater
- Lovelace Scientific Resources
-
-
Georgia
-
Gainesville, Georgia, Forente stater
- Arthritis Center of North GA
-
-
Idaho
-
Meridian, Idaho, Forente stater
- Idaho Arthritis Center
-
-
Illinois
-
Springfield, Illinois, Forente stater
- The Arthritis Center
-
-
Kansas
-
Wichita, Kansas, Forente stater
- Professional Research Network of Kansas
-
-
Maryland
-
Frederick, Maryland, Forente stater
- Arthritis Treatment Center
-
Hagerstown, Maryland, Forente stater
- Klein and Associates MD
-
-
Michigan
-
Lansing, Michigan, Forente stater
- Private practice
-
-
Minnesota
-
Rochester, Minnesota, Forente stater
- Mayo Clinic
-
-
North Carolina
-
Greenville, North Carolina, Forente stater
- Physicians East
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater
- Health Research of Oklahoma
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Forente stater
- Altoona Center Clinical Research
-
-
Texas
-
Austin, Texas, Forente stater
- Austin Rheumatology Research PA
-
Dallas, Texas, Forente stater
- Arthritis Centers Of Texas
-
Houston, Texas, Forente stater
- Pioneer Research Solutions Inc
-
Victoria, Texas, Forente stater
- Crossroads Clinical Research, LLC
-
-
Washington
-
Seattle, Washington, Forente stater
- Seattle Rheumatology Associates, PLLC
-
-
West Virginia
-
Clarksburg, West Virginia, Forente stater
- Mountain State Clinical Research
-
-
-
-
-
Strasbourg, Frankrike
- Hopitaux Universitaires de Strasbourg
-
-
-
-
-
Guatemala, Guatemala
- Reuma-Centro
-
Guatemala City, Guatemala
- Reuma S.A.
-
Guatemala City, Guatemala
- Centro Medico
-
Guatemala City, Guatemala
- Clinica de Especialidades Medicas
-
Guatemala City, Guatemala
- Clinica Medica Especializada en Reumatologia
-
Guatemala City, Guatemala
- Clinica Medica
-
-
-
-
-
Haifa, Israel
- Rambam Medical Center
-
Haifa, Israel
- Carmel Medical Center
-
Ramat Gan, Israel
- Sheba medical center
-
-
-
-
-
Adazi, Latvia
- M&M Centre Ltd.
-
Daugavplis, Latvia
- Meda D
-
Liepaja, Latvia
- L. Atikes doktorats
-
Riga, Latvia
- "Bruninieku" polyclinic
-
Riga, Latvia
- Arija's Ancane's Family Doctor
-
-
-
-
-
Guadalajara, Mexico
- Centro de Estudios de Investigacion Basica y Clinica, Sc
-
Mexico, Mexico
- Clinstile, S.A. de C.V.
-
Mexico, Mexico
- Hospital General de Mexico
-
Mexico, Mexico
- Arké Estudios Clínicos
-
Monterrey, Mexico
- Accelerium Clinical Research
-
Monterrey, Mexico
- Hospital Universitario José E. Gonzalez
-
San Luis Potosi, Mexico
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
-
-
-
-
-
Chisinau, Moldova, Republikken
- IMSP Institutul de Cardiologie
-
-
-
-
-
Auckland, New Zealand
- North Shore Hospital
-
Hamilton, New Zealand
- Waikato Hospital
-
Timaru, New Zealand
- Timaru Rheumatology Studies
-
-
-
-
-
Bialystok, Polen
- NZOZ Osteo-Medic s.c.
-
Bytom, Polen
- Silesiana Centrum Medyczne
-
Katowice, Polen
- Medica Pro Familia Sp. z o.o. S.K.A.
-
Krakow, Polen
- Centrum Medyczne Plejady
-
Krakow, Polen
- Nowomed
-
Krakow, Polen
- Nzoz "Dobry Lekarz"
-
Skierniewice, Polen
- NZOZ Przychodnia Lekarska "Eskulap"
-
Sroda Wielkopolska, Polen
- NS ZOZ Medicus Bonus
-
Starachowice, Polen
- Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
-
Torun, Polen
- NZOZ Nasz Lekarz
-
Warsaw, Polen
- AMED Medical Center
-
Wroclaw, Polen
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
-
-
-
-
-
Cordoba, Spania
- Hospital Reina Sofa
-
Coruña, Spania
- Complejo Hospitalario Universitario A Coruña
-
Elche, Spania
- Hospital General Universitario de Elche
-
Mostoles, Spania
- Hospital Universitario de Móstoles
-
Sabadell, Spania
- Consorci Sanitari Parc Taulí
-
Sevilla, Spania
- Hospital Infanta Luisa
-
-
-
-
-
Brno, Tsjekkia
- Revmatologie S.R.O
-
Kladno, Tsjekkia
- Ambulance Revmatologie a Interniho Lekarstvi
-
Praha-Nusle, Tsjekkia
- Revmatologicka ambulance
-
Uherske Hradiste, Tsjekkia
- Medical Plus, S.R.O.
-
Zlin, Tsjekkia
- PV-Medical
-
-
-
-
-
Berlin, Tyskland
- Schlossparkklinik - Akad. Lehrkrankenhaus Charite
-
Berlin, Tyskland
- Charite Mitte, Rheumatologie Neue Therapien
-
Frankfurt, Tyskland
- Klinikum Goethe-Universität
-
Hamburg, Tyskland
- Schwerpunktpraxis fuer Rheumatologie
-
Herne, Tyskland
- Rheumazentrum Ruhrgebiet
-
-
-
-
-
Donetsk, Ukraina
- V. Gusak Institute of Urgent and Recovery Surgery
-
Donetsk, Ukraina
- City Hospital #5
-
Kharkiv, Ukraina
- City Hospital #8
-
Kharkiv, Ukraina
- City Hospital #13
-
Kharkiv, Ukraina
- Government Institution
-
Kiev, Ukraina
- Central Outpatient Hospital of Deanyanskyy Distric
-
Kyiv, Ukraina
- Central regional polyclinic of Pechersk District
-
Lutsk, Ukraina
- Municipal Institution Lutsk City Clinical Hospital
-
-
-
-
-
Balatonfured, Ungarn
- DRC
-
Budapest, Ungarn
- Budai Irgalmasrendi Korhaz
-
Budapest, Ungarn
- Qualiclinic Ltd
-
Budapest, Ungarn
- Revita Clinic
-
Eger, Ungarn
- Markhot Ferenc Korhaz
-
Gyula, Ungarn
- Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
-
Veszprem, Ungarn
- Csolnoky Ferenc County Hospital
-
-
-
-
-
Wien, Østerrike
- Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: GLPG0634 50 mg QD
Deltakerne fikk GLPG0634 50 mg kapsler, oralt, QD i uke 1 til 12. Deltakere som responderte (med minst 20 % forbedring på TJC68 og SJC66) forble på 50 mg QD mens non-responders ble re-randomisert til 100 mg 1 Q3D i løpet av ukene til 24.
|
GLPG0634 kapsler.
|
|
Eksperimentell: GLPG0634 100 mg QD
Deltakerne fikk GLPG0634 100 mg kapsler, oralt, QD i uke 1 til 24.
|
GLPG0634 kapsler.
|
|
Eksperimentell: GLPG0634 200 mg QD
Deltakerne mottok GLPG0634 200 mg kapsler, oralt, QD i uke 1 til 24.
|
GLPG0634 kapsler.
|
|
Placebo komparator: 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.
|
Placebo kapsler.
|
|
Eksperimentell: 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.
|
GLPG0634 kapsler.
|
|
Eksperimentell: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
|
GLPG0634 kapsler.
|
|
Eksperimentell: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
|
GLPG0634 kapsler.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere som oppnår en American College of Rheumatology (ACR) 20 svar ved uke 12
Tidsramme: Uke 12
|
American College of Rheumatology (ACR)-responsen er et mål på forbedring i flere sykdomsvurderingskriterier.
ACR20-responsen er definert som: 1) ≥ 20 % forbedring fra baseline i SJC66, og 2) ≥ 20 % forbedring fra baseline i anbud TJC68, og 3) ≥ 20 % forbedring fra baseline i minst 3 av følgende 5 elementer: 1. Smerte visuell analog skala (VAS) (hentet fra Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Pasientens globale vurdering av sykdomsaktivitet VAS, 3. Legens globale vurdering av sykdomsaktivitet VAS, 4. Total HAQ -DI score, og 5. CRP.
Ikke-responder-imputering ble brukt (dvs. for å imputere et manglende svar, ble deltakeren antatt å være en ikke-responder).
|
Uke 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere som oppnår en ACR20-respons ved uke 24
Tidsramme: Uke 24
|
ACR20-respons ble definert som: 1) ≥ 20 % forbedring fra baseline i SJC66, og 2) ≥ 20 % forbedring fra baseline i TJC68, og 3) ≥ 20 % forbedring fra baseline i minst 3 av følgende 5 elementer: 1. Smerte VAS (hentet fra HAQ-DI), 2. Pasientens globale vurdering av sykdomsaktivitet VAS, 3. Legens globale vurdering av sykdomsaktivitet VAS, 4. Total HAQ-DI-score og 5. CRP.
Ikke-reagerende imputering ble brukt.
|
Uke 24
|
|
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Tidsramme: 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.
|
Weeks 1, 2, 4, 8, 12, and 24
|
|
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
Tidsramme: 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.
|
Weeks 1, 2, 4, 8, 12, and 24
|
|
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
Tidsramme: 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).
|
Weeks 1, 2, 4, 8, 12, and 24
|
|
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
Tidsramme: 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.
|
Weeks 1, 2, 4, 8, 12, and 24
|
|
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
Tidsramme: 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.
|
Weeks 2, 4, 8, 12, and 24
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
Tidsramme: 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
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
Tidsramme: 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.
|
Baseline and Weeks 1, 2, 4, 8, 12, and 24
|
|
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24
Tidsramme: 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.
|
Baseline and Weeks 4, 12, and 24
|
|
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
Tidsramme: 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.
|
Baseline and Weeks 4, 12, and 24
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. juli 2013
Primær fullføring (Faktiske)
18. februar 2015
Studiet fullført (Faktiske)
14. mai 2015
Datoer for studieregistrering
Først innsendt
26. juni 2013
Først innsendt som oppfylte QC-kriteriene
27. juni 2013
Først lagt ut (Anslag)
28. juni 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GLPG0634-CL-203 (DARWIN1)
- 2012-003635-31 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .