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

26 de outubro de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

  • Treatment duration was 24 weeks in total.
  • However, at Week 12, participants on placebo who did not achieve a 20% improvement in swollen joint count(SJC66) and tender joint count (TJC68) were re-randomized (automatically via interactive voice/web response [IXRS]) to treatment to receive GLPG0634 100 mg QD or 50 mg BID doses in a blinded fashion, participants on 50 mg QD who had not achieved a 20% improvement in SJC66 and TJC68 were assigned to 100 mg QD and participants on 25 mg BID. who did not achieve a 20% improvement in SJC66 and TJC68 were assigned to 50 mg BID. All continued the study until Week 24.
  • Participants in the other groups maintained their randomized treatment until Week 24.

Tipo de estudo

Intervencional

Inscrição (Real)

599

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha
        • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
      • Berlin, Alemanha
        • Charite Mitte, Rheumatologie Neue Therapien
      • Frankfurt, Alemanha
        • Klinikum Goethe-Universität
      • Hamburg, Alemanha
        • Schwerpunktpraxis fuer Rheumatologie
      • Herne, Alemanha
        • Rheumazentrum Ruhrgebiet
  • 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
  • Austrália
      • Camperdown, Austrália
        • Royal Prince Alfred Hospital
      • Clayton, Austrália
        • Monash Medical Centre
      • Daw Park, Austrália
        • Repatriation General Hospital
      • Woolloongabba, Austrália
        • Princess Alexandra Hospital
  • Bulgária
      • Plovdiv, Bulgária
        • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
      • Ruse, Bulgária
        • MHAT Ruse AD
      • Sofia, Bulgária
        • Diagnostic Consultative Center "Sveta Anna" LTD
      • Sofia, Bulgária
        • Clinic of Rheumatology MHAT
      • Sofia, Bulgária
        • National Transport Hospital "Tsar Boris" III
      • Sofia, Bulgária
        • Rheumatology Clinic
  • Bélgica
      • Brussels, Bélgica
        • Cliniques Universitaires St-Luc
      • Brussels, Bélgica
        • Hospital Brugmann
      • Hasselt, Bélgica
        • Rheuma Instituut
      • Kortrijk, Bélgica
        • AZ Groeninge
      • Leuven, Bélgica
        • UZ Leuven
      • Liege, Bélgica
        • CHU de Liege
  • 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
  • Colômbia
      • Barranquilla, Colômbia
        • Centro Integral de Reumatologia de Caribe
      • Barranquilla, Colômbia
        • Fundación del caribe para la investigación medica Fundación BIOS
      • Bogota, Colômbia
        • Cirei Sas
      • Bogota, Colômbia
        • Idearg S.A.S.
      • Bogota, Colômbia
        • Centro Integral de Reumatologia e Inmunologia SAS
      • Bucaramanga, Colômbia
        • Medicity S.A.S.
      • Cali, Colômbia
        • Clinica de Arthritis Temprana S.A.S.
      • Cundinamarca, Colômbia
        • Preventive Care SAS
      • Medellin, Colômbia
        • Hospital Pablo Tobon Uribe
  • Espanha
      • Cordoba, Espanha
        • Hospital Reina Sofa
      • Coruña, Espanha
        • Complejo Hospitalario Universitario A Coruña
      • Elche, Espanha
        • Hospital General Universitario de Elche
      • Mostoles, Espanha
        • Hospital Universitario de Móstoles
      • Sabadell, Espanha
        • Consorci Sanitari Parc Taulí
      • Sevilla, Espanha
        • Hospital Infanta Luisa
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert, Arizona, Estados Unidos
        • Artho Care, Arthritis Care & Research P.C.
      • Phoenix, Arizona, Estados Unidos
        • Arizona Arthritis & Rheumatology Research PLLC
    • California
      • Hemet, California, Estados Unidos
        • C.V. Mehta MD Medical Corporation
      • La Jolla, California, Estados Unidos
        • Center for Innovative TherapyDivision of Rheumatology, UCSD
      • Palm Desert, California, Estados Unidos
        • Desert Medical Advances
      • Victorville, California, Estados Unidos
        • Desert Valley Medical Center
      • West Hills, California, Estados Unidos
        • Infosphere Clinical Research, Inc.
    • Florida
      • Boca Raton, Florida, Estados Unidos
        • RASF Clinical Research Center
      • Ormond Beach, Florida, Estados Unidos
        • Millennium Research
      • Venice, Florida, Estados Unidos
        • Lovelace Scientific Resources
    • Georgia
      • Gainesville, Georgia, Estados Unidos
        • Arthritis Center of North GA
    • Idaho
      • Meridian, Idaho, Estados Unidos
        • Idaho Arthritis Center
    • Illinois
      • Springfield, Illinois, Estados Unidos
        • The Arthritis Center
    • Kansas
      • Wichita, Kansas, Estados Unidos
        • Professional Research Network of Kansas
    • Maryland
      • Frederick, Maryland, Estados Unidos
        • Arthritis Treatment Center
      • Hagerstown, Maryland, Estados Unidos
        • Klein and Associates MD
    • Michigan
      • Lansing, Michigan, Estados Unidos
        • Private practice
    • Minnesota
      • Rochester, Minnesota, Estados Unidos
        • Mayo Clinic
    • North Carolina
      • Greenville, North Carolina, Estados Unidos
        • Physicians East
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, Estados Unidos
        • Altoona Center Clinical Research
    • Texas
      • Austin, Texas, Estados Unidos
        • Austin Rheumatology Research PA
      • Dallas, Texas, Estados Unidos
        • Arthritis Centers Of Texas
      • Houston, Texas, Estados Unidos
        • Pioneer Research Solutions Inc
      • Victoria, Texas, Estados Unidos
        • Crossroads Clinical Research, LLC
    • Washington
      • Seattle, Washington, Estados Unidos
        • Seattle Rheumatology Associates, PLLC
    • West Virginia
      • Clarksburg, West Virginia, Estados Unidos
        • Mountain State Clinical Research
  • Federação Russa
      • Moscow, Federação Russa
        • I.M. Sechenov First Moscow State Medical University
      • Moscow, Federação Russa
        • Research Institute of Rheumatology RAMS
      • Moscow, Federação Russa
        • State University of Medicine and Dentistry
      • Nizhniy Novgorod, Federação Russa
        • City Clinical Hospital 5
      • Ryazan, Federação Russa
        • Ryazan State Medical University
      • St Petersburg, Federação Russa
        • City Hospital # 26
      • Vladimir, Federação Russa
        • Vladimir Reg Clin Hosp
  • França
      • Strasbourg, França
        • 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
  • Hungria
      • Balatonfured, Hungria
        • DRC
      • Budapest, Hungria
        • Budai Irgalmasrendi Korhaz
      • Budapest, Hungria
        • Qualiclinic Ltd
      • Budapest, Hungria
        • Revita Clinic
      • Eger, Hungria
        • Markhot Ferenc Korhaz
      • Gyula, Hungria
        • Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
      • Veszprem, Hungria
        • Csolnoky Ferenc County Hospital
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • Carmel Medical Center
      • Ramat Gan, Israel
        • Sheba medical center
  • Letônia
      • Adazi, Letônia
        • M&M Centre Ltd.
      • Daugavplis, Letônia
        • Meda D
      • Liepaja, Letônia
        • L. Atikes doktorats
      • Riga, Letônia
        • "Bruninieku" polyclinic
      • Riga, Letônia
        • Arija's Ancane's Family Doctor
  • Moldávia, República da
      • Chisinau, Moldávia, República da
        • IMSP Institutul de Cardiologie
  • México
      • Guadalajara, México
        • Centro de Estudios de Investigacion Basica y Clinica, Sc
      • Mexico, México
        • Clinstile, S.A. de C.V.
      • Mexico, México
        • Hospital General de Mexico
      • Mexico, México
        • Arké Estudios Clínicos
      • Monterrey, México
        • Accelerium Clinical Research
      • Monterrey, México
        • Hospital Universitario José E. Gonzalez
      • San Luis Potosi, México
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
  • Nova Zelândia
      • Auckland, Nova Zelândia
        • North Shore Hospital
      • Hamilton, Nova Zelândia
        • Waikato Hospital
      • Timaru, Nova Zelândia
        • Timaru Rheumatology Studies
  • Polônia
      • Bialystok, Polônia
        • NZOZ Osteo-Medic s.c.
      • Bytom, Polônia
        • Silesiana Centrum Medyczne
      • Katowice, Polônia
        • Medica Pro Familia Sp. z o.o. S.K.A.
      • Krakow, Polônia
        • Centrum Medyczne Plejady
      • Krakow, Polônia
        • Nowomed
      • Krakow, Polônia
        • Nzoz "Dobry Lekarz"
      • Skierniewice, Polônia
        • NZOZ Przychodnia Lekarska "Eskulap"
      • Sroda Wielkopolska, Polônia
        • NS ZOZ Medicus Bonus
      • Starachowice, Polônia
        • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
      • Torun, Polônia
        • NZOZ Nasz Lekarz
      • Warsaw, Polônia
        • AMED Medical Center
      • Wroclaw, Polônia
        • Wojewodzki Szpital Specjalistyczny We Wroclawiu
  • Tcheca
      • Brno, Tcheca
        • Revmatologie S.R.O
      • Kladno, Tcheca
        • Ambulance Revmatologie a Interniho Lekarstvi
      • Praha-Nusle, Tcheca
        • Revmatologicka ambulance
      • Uherske Hradiste, Tcheca
        • Medical Plus, S.R.O.
      • Zlin, Tcheca
        • PV-Medical
  • Ucrânia
      • Donetsk, Ucrânia
        • V. Gusak Institute of Urgent and Recovery Surgery
      • Donetsk, Ucrânia
        • City Hospital #5
      • Kharkiv, Ucrânia
        • City Hospital #8
      • Kharkiv, Ucrânia
        • City Hospital #13
      • Kharkiv, Ucrânia
        • Government Institution
      • Kiev, Ucrânia
        • Central Outpatient Hospital of Deanyanskyy Distric
      • Kyiv, Ucrânia
        • Central regional polyclinic of Pechersk District
      • Lutsk, Ucrânia
        • Municipal Institution Lutsk City Clinical Hospital
  • Áustria
      • Wien, Áustria
        • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: GLPG0634 50 mg QD
Os participantes receberam GLPG0634 cápsulas de 50 mg, por via oral, QD durante as semanas 1 a 12. Os participantes que responderam (com pelo menos 20% de melhora em TJC68 e SJC66) permaneceram em 50 mg QD enquanto os não respondedores foram randomizados novamente para 100 mg QD durante as semanas 13 a 24.
Medicamento: GLPG0634
Cápsulas GLPG0634.
Experimental: GLPG0634 100 mg QD
Os participantes receberam GLPG0634 cápsulas de 100 mg, por via oral, QD durante as semanas 1 a 24.
Medicamento: GLPG0634
Cápsulas GLPG0634.
Experimental: GLPG0634 200 mg QD
Os participantes receberam GLPG0634 cápsulas de 200 mg, por via oral, QD durante as semanas 1 a 24.
Medicamento: GLPG0634
Cápsulas GLPG0634.
Comparador de Placebo: Placebo
Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.
Medicamento: Placebo
Cápsulas placebo.
Experimental: 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.
Medicamento: GLPG0634
Cápsulas GLPG0634.
Experimental: GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Medicamento: GLPG0634
Cápsulas GLPG0634.
Experimental: GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Medicamento: GLPG0634
Cápsulas GLPG0634.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Porcentagem de participantes que obtiveram uma resposta do American College of Rheumatology (ACR) 20 na semana 12
Prazo: Semana 12
A resposta do American College of Rheumatology (ACR) é uma medida de melhora em vários critérios de avaliação de doenças. A resposta ACR20 é definida como: 1) ≥ 20% de melhora desde a linha de base em SJC66, e 2) ≥ 20% de melhora desde a linha de base em tender TJC68, e 3) ≥ 20% de melhora desde a linha de base em pelo menos 3 dos 5 itens a seguir: 1. Escala analógica visual de dor (VAS) (retirada do Questionário de Avaliação de Saúde - Índice de Incapacidade [HAQ-DI]), 2. Avaliação Global do Paciente da Atividade da Doença VAS, 3. Avaliação Global do Médico da Atividade da Doença VAS, 4. HAQ Total -DI, e 5. PCR. A imputação de não respondedor foi usada (ou seja, para imputar uma resposta ausente, o participante foi considerado um não respondedor).
Semana 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Porcentagem de participantes que alcançaram uma resposta ACR20 na semana 24
Prazo: Semana 24
A resposta ACR20 foi definida como: 1) ≥ 20% de melhora desde a linha de base em SJC66, e 2) ≥ 20% de melhora desde a linha de base em TJC68, e 3) ≥ 20% de melhora desde a linha de base em pelo menos 3 dos 5 itens a seguir: 1. Dor VAS (retirado do HAQ-DI), 2. Avaliação global do paciente da atividade da doença VAS, 3. Avaliação global do médico da atividade da doença VAS, 4. Pontuação total do HAQ-DI e 5. PCR. A imputação de não respondedor foi usada.
Semana 24
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Galapagos NV

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de julho de 2013

Conclusão Primária (Real)

18 de fevereiro de 2015

Conclusão do estudo (Real)

14 de maio de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de junho de 2013

Primeira postagem (Estimativa)

28 de junho de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de novembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de outubro de 2020

Última verificação

1 de outubro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

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