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Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)

26. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

599

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • 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
  • Australien
      • Camperdown, Australien
        • Royal Prince Alfred Hospital
      • Clayton, Australien
        • Monash Medical Centre
      • Daw Park, Australien
        • Repatriation General Hospital
      • Woolloongabba, Australien
        • Princess Alexandra Hospital
  • Belgien
      • Brussels, Belgien
        • Cliniques Universitaires St-Luc
      • Brussels, Belgien
        • Hospital Brugmann
      • Hasselt, Belgien
        • Rheuma Instituut
      • Kortrijk, Belgien
        • AZ Groeninge
      • Leuven, Belgien
        • UZ Leuven
      • Liege, Belgien
        • CHU de Liège
  • Bulgarien
      • Plovdiv, Bulgarien
        • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
      • Ruse, Bulgarien
        • MHAT Ruse AD
      • Sofia, Bulgarien
        • Diagnostic Consultative Center "Sveta Anna" LTD
      • Sofia, Bulgarien
        • Clinic of Rheumatology MHAT
      • Sofia, Bulgarien
        • National Transport Hospital "Tsar Boris" III
      • Sofia, Bulgarien
        • Rheumatology Clinic
  • Chile
      • 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
  • Colombia
      • 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 Tobón Uribe
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • I.M. Sechenov First Moscow State Medical University
      • Moscow, Den Russiske Føderation
        • Research Institute of Rheumatology RAMS
      • Moscow, Den Russiske Føderation
        • State University of Medicine and Dentistry
      • Nizhniy Novgorod, Den Russiske Føderation
        • City Clinical Hospital 5
      • Ryazan, Den Russiske Føderation
        • Ryazan State Medical University
      • St Petersburg, Den Russiske Føderation
        • City Hospital # 26
      • Vladimir, Den Russiske Føderation
        • Vladimir Reg Clin Hosp
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert, Arizona, Forenede Stater
        • Artho Care, Arthritis Care & Research P.C.
      • Phoenix, Arizona, Forenede Stater
        • Arizona Arthritis & Rheumatology Research PLLC
    • California
      • Hemet, California, Forenede Stater
        • C.V. Mehta MD Medical Corporation
      • La Jolla, California, Forenede Stater
        • Center for Innovative TherapyDivision of Rheumatology, UCSD
      • Palm Desert, California, Forenede Stater
        • Desert Medical Advances
      • Victorville, California, Forenede Stater
        • Desert Valley Medical Center
      • West Hills, California, Forenede Stater
        • Infosphere Clinical Research, Inc.
    • Florida
      • Boca Raton, Florida, Forenede Stater
        • RASF Clinical Research Center
      • Ormond Beach, Florida, Forenede Stater
        • Millennium Research
      • Venice, Florida, Forenede Stater
        • Lovelace Scientific Resources
    • Georgia
      • Gainesville, Georgia, Forenede Stater
        • Arthritis Center of North GA
    • Idaho
      • Meridian, Idaho, Forenede Stater
        • Idaho Arthritis Center
    • Illinois
      • Springfield, Illinois, Forenede Stater
        • The Arthritis Center
    • Kansas
      • Wichita, Kansas, Forenede Stater
        • Professional Research Network of Kansas
    • Maryland
      • Frederick, Maryland, Forenede Stater
        • Arthritis Treatment Center
      • Hagerstown, Maryland, Forenede Stater
        • Klein and Associates MD
    • Michigan
      • Lansing, Michigan, Forenede Stater
        • Private Practice
    • Minnesota
      • Rochester, Minnesota, Forenede Stater
        • Mayo Clinic
    • North Carolina
      • Greenville, North Carolina, Forenede Stater
        • Physicians East
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater
        • Altoona Center Clinical Research
    • Texas
      • Austin, Texas, Forenede Stater
        • Austin Rheumatology Research PA
      • Dallas, Texas, Forenede Stater
        • Arthritis Centers Of Texas
      • Houston, Texas, Forenede Stater
        • Pioneer Research Solutions Inc
      • Victoria, Texas, Forenede Stater
        • Crossroads Clinical Research, LLC
    • Washington
      • Seattle, Washington, Forenede Stater
        • Seattle Rheumatology Associates, PLLC
    • West Virginia
      • Clarksburg, West Virginia, Forenede Stater
        • Mountain State Clinical Research
  • Frankrig
      • Strasbourg, Frankrig
        • Hopitaux Universitaires de Strasbourg
  • Guatemala
      • Guatemala, Guatemala
        • Reuma-Centro
      • Guatemala City, Guatemala
        • Reuma S.A.
      • Guatemala City, Guatemala
        • Centro Médico
      • Guatemala City, Guatemala
        • Clinica de Especialidades Medicas
      • Guatemala City, Guatemala
        • Clinica Medica Especializada en Reumatologia
      • Guatemala City, Guatemala
        • Clinica Medica
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • Carmel Medical Center
      • Ramat Gan, Israel
        • Sheba Medical Center
  • Letland
      • Adazi, Letland
        • M&M Centre Ltd.
      • Daugavplis, Letland
        • Meda D
      • Liepaja, Letland
        • L. Atikes doktorats
      • Riga, Letland
        • "Bruninieku" polyclinic
      • Riga, Letland
        • Arija's Ancane's Family Doctor
  • Mexico
      • 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.
  • Moldova, Republikken
      • Chisinau, Moldova, Republikken
        • IMSP Institutul de Cardiologie
  • New Zealand
      • Auckland, New Zealand
        • North Shore Hospital
      • Hamilton, New Zealand
        • Waikato Hospital
      • Timaru, New Zealand
        • Timaru Rheumatology Studies
  • Polen
      • 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
  • Spanien
      • Cordoba, Spanien
        • Hospital Reina Sofa
      • Coruña, Spanien
        • Complejo Hospitalario Universitario A Coruna
      • Elche, Spanien
        • Hospital General Universitario de Elche
      • Mostoles, Spanien
        • Hospital Universitario de Móstoles
      • Sabadell, Spanien
        • Consorci Sanitari Parc Taulí
      • Sevilla, Spanien
        • Hospital Infanta Luisa
  • Tjekkiet
      • Brno, Tjekkiet
        • Revmatologie S.R.O
      • Kladno, Tjekkiet
        • Ambulance Revmatologie a Interniho Lekarstvi
      • Praha-Nusle, Tjekkiet
        • Revmatologicka ambulance
      • Uherske Hradiste, Tjekkiet
        • MEDICAL PLUS, s.r.o.
      • Zlin, Tjekkiet
        • PV-Medical
  • Tyskland
      • 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
  • Ukraine
      • Donetsk, Ukraine
        • V. Gusak Institute of Urgent and Recovery Surgery
      • Donetsk, Ukraine
        • City Hospital #5
      • Kharkiv, Ukraine
        • City Hospital #8
      • Kharkiv, Ukraine
        • City Hospital #13
      • Kharkiv, Ukraine
        • Government Institution
      • Kiev, Ukraine
        • Central Outpatient Hospital of Deanyanskyy Distric
      • Kyiv, Ukraine
        • Central regional polyclinic of Pechersk District
      • Lutsk, Ukraine
        • Municipal Institution Lutsk City Clinical Hospital
  • Ungarn
      • Balatonfured, Ungarn
        • DRC
      • Budapest, Ungarn
        • Budai Irgalmasrendi Kórház
      • 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
  • Østrig
      • Wien, Østrig
        • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GLPG0634 50 mg QD
Deltagerne modtog GLPG0634 50 mg kapsler, oralt, QD i uge 1 til 12. Deltagere, der responderede (med mindst 20 % forbedring af TJC68 og SJC66) forblev på 50 mg QD, mens non-responders blev re-randomiseret til 100 mg 1 3D i uger til 24.
Medicin: GLPG0634
GLPG0634 kapsler.
Eksperimentel: GLPG0634 100 mg QD
Deltagerne modtog GLPG0634 100 mg kapsler, oralt, QD i uge 1 til 24.
Medicin: GLPG0634
GLPG0634 kapsler.
Eksperimentel: GLPG0634 200 mg QD
Deltagerne modtog GLPG0634 200 mg kapsler, oralt, QD i uge 1 til 24.
Medicin: GLPG0634
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.
Medicin: Placebo
Placebo kapsler.
Eksperimentel: 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.
Medicin: GLPG0634
GLPG0634 kapsler.
Eksperimentel: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Medicin: GLPG0634
GLPG0634 kapsler.
Eksperimentel: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Medicin: GLPG0634
GLPG0634 kapsler.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere, der opnår et American College of Rheumatology (ACR) 20 svar i uge 12
Tidsramme: Uge 12
American College of Rheumatology (ACR) respons er en måling af forbedring i flere sygdomsvurderingskriterier. ACR20-responset er defineret som: 1) ≥ 20 % forbedring fra baseline i SJC66, og 2) ≥ 20 % forbedring fra baseline i udbud TJC68, og 3) ≥ 20 % forbedring fra baseline i mindst 3 af følgende 5 punkter: 1. Smertevisuel analog skala (VAS) (hentet fra Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Patients Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ -DI score, og 5. CRP. Ikke-responder-imputation blev brugt (dvs. for at imputere et manglende svar, blev deltageren antaget at være en ikke-responder).
Uge 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere, der opnår et ACR20-svar i uge 24
Tidsramme: Uge 24
ACR20-respons blev defineret som: 1) ≥ 20 % forbedring fra baseline i SJC66, og 2) ≥ 20 % forbedring fra baseline i TJC68, og 3) ≥ 20 % forbedring fra baseline i mindst 3 af følgende 5 punkter: 1. Smerte VAS (taget fra HAQ-DI), 2. Patientens globale vurdering af sygdomsaktivitet VAS, 3. Lægens globale vurdering af sygdomsaktivitet VAS, 4. Samlet HAQ-DI-score og 5. CRP. Non-responder imputation blev brugt.
Uge 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Galapagos NV

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juli 2013

Primær færdiggørelse (Faktiske)

18. februar 2015

Studieafslutning (Faktiske)

14. maj 2015

Datoer for studieregistrering

Først indsendt

26. juni 2013

Først indsendt, der opfyldte QC-kriterier

27. juni 2013

Først opslået (Skøn)

28. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GLPG0634-CL-203 (DARWIN1)
  • 2012-003635-31 (EudraCT nummer)

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