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

26 oktober 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • 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

Ingrijpend

Inschrijving (Werkelijk)

599

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië
        • Atencion Integral en Reumatologa
      • Buenos Aires, Argentinië
        • Rheumatology OMI
      • Cordoba, Argentinië
        • Instituto Reumatologico
      • Quilmes, Argentinië
        • Instituto Médico Cer
      • San Fernando, Argentinië
        • Instituto de Asistencia Reumatologia Integral
      • Tucuman, Argentinië
        • Centro Medico Privado de Reumatologia
  • Australië
      • Camperdown, Australië
        • Royal Prince Alfred Hospital
      • Clayton, Australië
        • Monash Medical Centre
      • Daw Park, Australië
        • Repatriation General Hospital
      • Woolloongabba, Australië
        • Princess Alexandra Hospital
  • België
      • Brussels, België
        • Cliniques Universitaires St-Luc
      • Brussels, België
        • Hospital Brugmann
      • Hasselt, België
        • Rheuma Instituut
      • Kortrijk, België
        • AZ Groeninge
      • Leuven, België
        • UZ Leuven
      • Liege, België
        • CHU de Liege
  • Bulgarije
      • Plovdiv, Bulgarije
        • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
      • Ruse, Bulgarije
        • MHAT Ruse AD
      • Sofia, Bulgarije
        • Diagnostic Consultative Center "Sveta Anna" LTD
      • Sofia, Bulgarije
        • Clinic of Rheumatology MHAT
      • Sofia, Bulgarije
        • National Transport Hospital "Tsar Boris" III
      • Sofia, Bulgarije
        • Rheumatology Clinic
  • Chili
      • Concepcion, Chili
        • Hospital Regional "Guillermo Grant Benavente"
      • Santiago, Chili
        • Prosalud
      • Santiago, Chili
        • Someal SA
      • Santiago, Chili
        • Instituto Terapias Oncologicas Providencia
      • Temuco, Chili
        • Private Office
      • Temuco, Chili
        • 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 Tobon Uribe
  • Duitsland
      • Berlin, Duitsland
        • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
      • Berlin, Duitsland
        • Charite Mitte, Rheumatologie Neue Therapien
      • Frankfurt, Duitsland
        • Klinikum Goethe-Universität
      • Hamburg, Duitsland
        • Schwerpunktpraxis fuer Rheumatologie
      • Herne, Duitsland
        • Rheumazentrum Ruhrgebiet
  • Frankrijk
      • Strasbourg, Frankrijk
        • Hopitaux Universitaires de Strasbourg
  • Guatemala
      • 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
  • Hongarije
      • Balatonfured, Hongarije
        • DRC
      • Budapest, Hongarije
        • Budai Irgalmasrendi Korhaz
      • Budapest, Hongarije
        • Qualiclinic Ltd
      • Budapest, Hongarije
        • Revita Clinic
      • Eger, Hongarije
        • Markhot Ferenc Korhaz
      • Gyula, Hongarije
        • Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
      • Veszprem, Hongarije
        • Csolnoky Ferenc County Hospital
  • Israël
      • Haifa, Israël
        • Rambam Medical Center
      • Haifa, Israël
        • Carmel Medical Center
      • Ramat Gan, Israël
        • 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.
  • Moldavië, Republiek
      • Chisinau, Moldavië, Republiek
        • IMSP Institutul de Cardiologie
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland
        • North Shore Hospital
      • Hamilton, Nieuw-Zeeland
        • Waikato Hospital
      • Timaru, Nieuw-Zeeland
        • Timaru Rheumatology Studies
  • Oekraïne
      • Donetsk, Oekraïne
        • V. Gusak Institute of Urgent and Recovery Surgery
      • Donetsk, Oekraïne
        • City Hospital #5
      • Kharkiv, Oekraïne
        • City Hospital #8
      • Kharkiv, Oekraïne
        • City Hospital #13
      • Kharkiv, Oekraïne
        • Government Institution
      • Kiev, Oekraïne
        • Central Outpatient Hospital of Deanyanskyy Distric
      • Kyiv, Oekraïne
        • Central regional polyclinic of Pechersk District
      • Lutsk, Oekraïne
        • Municipal Institution Lutsk City Clinical Hospital
  • Oostenrijk
      • Wien, Oostenrijk
        • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
  • 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
  • Russische Federatie
      • Moscow, Russische Federatie
        • I.M. Sechenov First Moscow State Medical University
      • Moscow, Russische Federatie
        • Research Institute of Rheumatology RAMS
      • Moscow, Russische Federatie
        • State University of Medicine and Dentistry
      • Nizhniy Novgorod, Russische Federatie
        • City Clinical Hospital 5
      • Ryazan, Russische Federatie
        • Ryazan State Medical University
      • St Petersburg, Russische Federatie
        • City Hospital # 26
      • Vladimir, Russische Federatie
        • Vladimir Reg Clin Hosp
  • Spanje
      • Cordoba, Spanje
        • Hospital Reina Sofa
      • Coruña, Spanje
        • Complejo Hospitalario Universitario A Coruña
      • Elche, Spanje
        • Hospital General Universitario de Elche
      • Mostoles, Spanje
        • Hospital Universitario de Móstoles
      • Sabadell, Spanje
        • Consorci Sanitari Parc Taulí
      • Sevilla, Spanje
        • Hospital Infanta Luisa
  • Tsjechië
      • Brno, Tsjechië
        • Revmatologie S.R.O
      • Kladno, Tsjechië
        • Ambulance Revmatologie a Interniho Lekarstvi
      • Praha-Nusle, Tsjechië
        • Revmatologicka ambulance
      • Uherske Hradiste, Tsjechië
        • Medical Plus, S.R.O.
      • Zlin, Tsjechië
        • PV-Medical
  • Verenigde Staten
    • Alabama
      • Huntsville, Alabama, Verenigde Staten
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert, Arizona, Verenigde Staten
        • Artho Care, Arthritis Care & Research P.C.
      • Phoenix, Arizona, Verenigde Staten
        • Arizona Arthritis & Rheumatology Research PLLC
    • California
      • Hemet, California, Verenigde Staten
        • C.V. Mehta MD Medical Corporation
      • La Jolla, California, Verenigde Staten
        • Center for Innovative TherapyDivision of Rheumatology, UCSD
      • Palm Desert, California, Verenigde Staten
        • Desert Medical Advances
      • Victorville, California, Verenigde Staten
        • Desert Valley Medical Center
      • West Hills, California, Verenigde Staten
        • Infosphere Clinical Research, Inc.
    • Florida
      • Boca Raton, Florida, Verenigde Staten
        • RASF Clinical Research Center
      • Ormond Beach, Florida, Verenigde Staten
        • Millennium Research
      • Venice, Florida, Verenigde Staten
        • Lovelace Scientific Resources
    • Georgia
      • Gainesville, Georgia, Verenigde Staten
        • Arthritis Center of North GA
    • Idaho
      • Meridian, Idaho, Verenigde Staten
        • Idaho Arthritis Center
    • Illinois
      • Springfield, Illinois, Verenigde Staten
        • The Arthritis Center
    • Kansas
      • Wichita, Kansas, Verenigde Staten
        • Professional Research Network of Kansas
    • Maryland
      • Frederick, Maryland, Verenigde Staten
        • Arthritis Treatment Center
      • Hagerstown, Maryland, Verenigde Staten
        • Klein and Associates MD
    • Michigan
      • Lansing, Michigan, Verenigde Staten
        • Private practice
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten
        • Mayo Clinic
    • North Carolina
      • Greenville, North Carolina, Verenigde Staten
        • Physicians East
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, Verenigde Staten
        • Altoona Center Clinical Research
    • Texas
      • Austin, Texas, Verenigde Staten
        • Austin Rheumatology Research PA
      • Dallas, Texas, Verenigde Staten
        • Arthritis Centers Of Texas
      • Houston, Texas, Verenigde Staten
        • Pioneer Research Solutions Inc
      • Victoria, Texas, Verenigde Staten
        • Crossroads Clinical Research, LLC
    • Washington
      • Seattle, Washington, Verenigde Staten
        • Seattle Rheumatology Associates, PLLC
    • West Virginia
      • Clarksburg, West Virginia, Verenigde Staten
        • Mountain State Clinical Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GLPG0634 50 mg eenmaal daags
Deelnemers kregen GLPG0634 50 mg capsules, oraal, QD in week 1 tot 12. Deelnemers die responders waren (met ten minste 20% verbetering op TJC68 en SJC66) bleven op 50 mg QD terwijl niet-responders opnieuw werden gerandomiseerd naar 100 mg QD in week 13 tot 24.
Geneesmiddel: GLPG0634
GLPG0634-capsules.
Experimenteel: GLPG0634 100 mg eenmaal daags
Deelnemers kregen GLPG0634 100 mg capsules, oraal, QD gedurende week 1 tot 24.
Geneesmiddel: GLPG0634
GLPG0634-capsules.
Experimenteel: GLPG0634 200 mg eenmaal daags
Deelnemers kregen GLPG0634 200 mg capsules, oraal, QD gedurende week 1 tot 24.
Geneesmiddel: GLPG0634
GLPG0634-capsules.
Placebo-vergelijker: 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.
Geneesmiddel: Placebo
Placebo-capsules.
Experimenteel: 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.
Geneesmiddel: GLPG0634
GLPG0634-capsules.
Experimenteel: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Geneesmiddel: GLPG0634
GLPG0634-capsules.
Experimenteel: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Geneesmiddel: GLPG0634
GLPG0634-capsules.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage deelnemers dat een respons van het American College of Rheumatology (ACR) 20 behaalt in week 12
Tijdsspanne: Week 12
De respons van het American College of Rheumatology (ACR) is een meting van verbetering in meerdere ziektebeoordelingscriteria. De ACR20-respons wordt gedefinieerd als: 1) ≥ 20% verbetering ten opzichte van baseline in SJC66, en 2) ≥ 20% verbetering ten opzichte van baseline in gevoelige TJC68, en 3) ≥ 20% verbetering ten opzichte van baseline in ten minste 3 van de volgende 5 items: 1. Pijn visuele analoge schaal (VAS) (afkomstig van de Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Patiënt Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ -DI-score, en 5. CRP. Non-responder imputatie werd gebruikt (dwz om een ​​ontbrekende respons toe te rekenen, werd aangenomen dat de deelnemer een non-responder was).
Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage deelnemers dat een ACR20-respons behaalt in week 24
Tijdsspanne: Week 24
ACR20-respons werd gedefinieerd als: 1) ≥ 20% verbetering ten opzichte van baseline in SJC66, en 2) ≥ 20% verbetering ten opzichte van baseline in TJC68, en 3) ≥ 20% verbetering ten opzichte van baseline in ten minste 3 van de volgende 5 items: 1. Pijn VAS (overgenomen uit de HAQ-DI), 2. Patiënt's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Totale HAQ-DI-score, en 5. CRP. Non-responder imputatie werd gebruikt.
Week 24
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Galapagos NV

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 juli 2013

Primaire voltooiing (Werkelijk)

18 februari 2015

Studie voltooiing (Werkelijk)

14 mei 2015

Studieregistratiedata

Eerst ingediend

26 juni 2013

Eerst ingediend dat voldeed aan de QC-criteria

27 juni 2013

Eerst geplaatst (Schatting)

28 juni 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 november 2020

Laatste update ingediend die voldeed aan QC-criteria

26 oktober 2020

Laatst geverifieerd

1 oktober 2020

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Termen gerelateerd aan deze studie

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Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

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