此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2020年10月26日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

  • 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.

研究类型

介入性

注册 (实际的)

599

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Donetsk、乌克兰
        • V. Gusak Institute of Urgent and Recovery Surgery
      • Donetsk、乌克兰
        • City Hospital #5
      • Kharkiv、乌克兰
        • City Hospital #8
      • Kharkiv、乌克兰
        • City Hospital #13
      • Kharkiv、乌克兰
        • Government Institution
      • Kiev、乌克兰
        • Central Outpatient Hospital of Deanyanskyy Distric
      • Kyiv、乌克兰
        • Central regional polyclinic of Pechersk District
      • Lutsk、乌克兰
        • Municipal Institution Lutsk City Clinical Hospital
  • 以色列
      • Haifa、以色列
        • Rambam Medical Center
      • Haifa、以色列
        • Carmel Medical Center
      • Ramat Gan、以色列
        • Sheba Medical Center
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦
        • I.M. Sechenov First Moscow State Medical University
      • Moscow、俄罗斯联邦
        • Research Institute of Rheumatology RAMS
      • Moscow、俄罗斯联邦
        • State University of Medicine and Dentistry
      • Nizhniy Novgorod、俄罗斯联邦
        • City Clinical Hospital 5
      • Ryazan、俄罗斯联邦
        • Ryazan State Medical University
      • St Petersburg、俄罗斯联邦
        • City Hospital # 26
      • Vladimir、俄罗斯联邦
        • Vladimir Reg Clin Hosp
  • 保加利亚
      • Plovdiv、保加利亚
        • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
      • Ruse、保加利亚
        • MHAT Ruse AD
      • Sofia、保加利亚
        • Diagnostic Consultative Center "Sveta Anna" LTD
      • Sofia、保加利亚
        • Clinic of Rheumatology MHAT
      • Sofia、保加利亚
        • National Transport Hospital "Tsar Boris" III
      • Sofia、保加利亚
        • Rheumatology Clinic
  • 匈牙利
      • Balatonfured、匈牙利
        • DRC
      • Budapest、匈牙利
        • Budai Irgalmasrendi Korhaz
      • Budapest、匈牙利
        • Qualiclinic Ltd
      • Budapest、匈牙利
        • Revita Clinic
      • Eger、匈牙利
        • Markhot Ferenc Korhaz
      • Gyula、匈牙利
        • Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
      • Veszprem、匈牙利
        • Csolnoky Ferenc County Hospital
  • 危地马拉
      • Guatemala、危地马拉
        • Reuma-Centro
      • Guatemala City、危地马拉
        • Reuma S.A.
      • Guatemala City、危地马拉
        • Centro Medico
      • Guatemala City、危地马拉
        • Clinica de Especialidades Medicas
      • Guatemala City、危地马拉
        • Clinica Medica Especializada en Reumatologia
      • Guatemala City、危地马拉
        • Clinica Medica
  • 哥伦比亚
      • Barranquilla、哥伦比亚
        • Centro Integral de Reumatologia de Caribe
      • Barranquilla、哥伦比亚
        • Fundación del caribe para la investigación medica Fundación BIOS
      • Bogota、哥伦比亚
        • Cirei Sas
      • Bogota、哥伦比亚
        • Idearg S.A.S.
      • Bogota、哥伦比亚
        • Centro Integral de Reumatologia e Inmunologia SAS
      • Bucaramanga、哥伦比亚
        • Medicity S.A.S.
      • Cali、哥伦比亚
        • Clinica de Arthritis Temprana S.A.S.
      • Cundinamarca、哥伦比亚
        • Preventive Care SAS
      • Medellin、哥伦比亚
        • Hospital Pablo Tobon Uribe
  • 墨西哥
      • Guadalajara、墨西哥
        • Centro de Estudios de Investigacion Basica y Clinica, Sc
      • Mexico、墨西哥
        • Clinstile, S.A. de C.V.
      • Mexico、墨西哥
        • Hospital General de Mexico
      • Mexico、墨西哥
        • Arké Estudios Clínicos
      • Monterrey、墨西哥
        • Accelerium Clinical Research
      • Monterrey、墨西哥
        • Hospital Universitario José E. Gonzalez
      • San Luis Potosi、墨西哥
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
  • 奥地利
      • Wien、奥地利
        • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
  • 德国
      • Berlin、德国
        • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
      • Berlin、德国
        • Charite Mitte, Rheumatologie Neue Therapien
      • Frankfurt、德国
        • Klinikum Goethe-Universität
      • Hamburg、德国
        • Schwerpunktpraxis fuer Rheumatologie
      • Herne、德国
        • Rheumazentrum Ruhrgebiet
  • 拉脱维亚
      • Adazi、拉脱维亚
        • M&M Centre Ltd.
      • Daugavplis、拉脱维亚
        • Meda D
      • Liepaja、拉脱维亚
        • L. Atikes doktorats
      • Riga、拉脱维亚
        • "Bruninieku" polyclinic
      • Riga、拉脱维亚
        • Arija's Ancane's Family Doctor
  • 捷克语
      • Brno、捷克语
        • Revmatologie S.R.O
      • Kladno、捷克语
        • Ambulance Revmatologie a Interniho Lekarstvi
      • Praha-Nusle、捷克语
        • Revmatologicka ambulance
      • Uherske Hradiste、捷克语
        • Medical Plus, S.R.O.
      • Zlin、捷克语
        • PV-Medical
  • 摩尔多瓦共和国
      • Chisinau、摩尔多瓦共和国
        • IMSP Institutul de Cardiologie
  • 新西兰
      • Auckland、新西兰
        • North Shore Hospital
      • Hamilton、新西兰
        • Waikato Hospital
      • Timaru、新西兰
        • Timaru Rheumatology Studies
  • 智利
      • Concepcion、智利
        • Hospital Regional "Guillermo Grant Benavente"
      • Santiago、智利
        • PROSALUD
      • Santiago、智利
        • Someal SA
      • Santiago、智利
        • Instituto Terapias Oncologicas Providencia
      • Temuco、智利
        • Private office
      • Temuco、智利
        • Centro de Investigacion Clínica del Sur Freire
  • 比利时
      • Brussels、比利时
        • Cliniques Universitaires St-Luc
      • Brussels、比利时
        • Hospital Brugmann
      • Hasselt、比利时
        • Rheuma Instituut
      • Kortrijk、比利时
        • AZ Groeninge
      • Leuven、比利时
        • UZ Leuven
      • Liege、比利时
        • CHU de Liège
  • 法国
      • Strasbourg、法国
        • Hôpitaux Universitaires de Strasbourg
  • 波兰
      • Bialystok、波兰
        • NZOZ Osteo-Medic s.c.
      • Bytom、波兰
        • Silesiana Centrum Medyczne
      • Katowice、波兰
        • Medica Pro Familia sp. z o.o. S.K.A.
      • Krakow、波兰
        • Centrum Medyczne Plejady
      • Krakow、波兰
        • Nowomed
      • Krakow、波兰
        • Nzoz "Dobry Lekarz"
      • Skierniewice、波兰
        • NZOZ Przychodnia Lekarska "Eskulap"
      • Sroda Wielkopolska、波兰
        • NS ZOZ Medicus Bonus
      • Starachowice、波兰
        • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
      • Torun、波兰
        • NZOZ Nasz Lekarz
      • Warsaw、波兰
        • AMED Medical Center
      • Wroclaw、波兰
        • Wojewodzki Szpital Specjalistyczny We Wroclawiu
  • 澳大利亚
      • Camperdown、澳大利亚
        • Royal Prince Alfred Hospital
      • Clayton、澳大利亚
        • Monash Medical Centre
      • Daw Park、澳大利亚
        • Repatriation General Hospital
      • Woolloongabba、澳大利亚
        • Princess Alexandra Hospital
  • 美国
    • Alabama
      • Huntsville、Alabama、美国
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Gilbert、Arizona、美国
        • Artho Care, Arthritis Care & Research P.C.
      • Phoenix、Arizona、美国
        • Arizona Arthritis & Rheumatology Research PLLC
    • California
      • Hemet、California、美国
        • C.V. Mehta MD Medical Corporation
      • La Jolla、California、美国
        • Center for Innovative TherapyDivision of Rheumatology, UCSD
      • Palm Desert、California、美国
        • Desert Medical Advances
      • Victorville、California、美国
        • Desert Valley Medical Center
      • West Hills、California、美国
        • Infosphere Clinical Research, Inc.
    • Florida
      • Boca Raton、Florida、美国
        • RASF Clinical Research Center
      • Ormond Beach、Florida、美国
        • Millennium Research
      • Venice、Florida、美国
        • Lovelace Scientific Resources
    • Georgia
      • Gainesville、Georgia、美国
        • Arthritis Center of North GA
    • Idaho
      • Meridian、Idaho、美国
        • Idaho Arthritis Center
    • Illinois
      • Springfield、Illinois、美国
        • The Arthritis Center
    • Kansas
      • Wichita、Kansas、美国
        • Professional Research Network of Kansas
    • Maryland
      • Frederick、Maryland、美国
        • Arthritis Treatment Center
      • Hagerstown、Maryland、美国
        • Klein and Associates MD
    • Michigan
      • Lansing、Michigan、美国
        • Private Practice
    • Minnesota
      • Rochester、Minnesota、美国
        • Mayo Clinic
    • North Carolina
      • Greenville、North Carolina、美国
        • Physicians East
    • Oklahoma
      • Oklahoma City、Oklahoma、美国
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville、Pennsylvania、美国
        • Altoona Center Clinical Research
    • Texas
      • Austin、Texas、美国
        • Austin Rheumatology Research PA
      • Dallas、Texas、美国
        • Arthritis Centers of Texas
      • Houston、Texas、美国
        • Pioneer Research Solutions Inc
      • Victoria、Texas、美国
        • Crossroads Clinical Research, LLC
    • Washington
      • Seattle、Washington、美国
        • Seattle Rheumatology Associates, PLLC
    • West Virginia
      • Clarksburg、West Virginia、美国
        • Mountain State Clinical Research
  • 西班牙
      • Cordoba、西班牙
        • Hospital Reina Sofa
      • Coruña、西班牙
        • Complejo Hospitalario Universitario A Coruña
      • Elche、西班牙
        • Hospital General Universitario de Elche
      • Mostoles、西班牙
        • Hospital Universitario de Móstoles
      • Sabadell、西班牙
        • Consorci Sanitari Parc Tauli
      • Sevilla、西班牙
        • Hospital Infanta Luisa
  • 阿根廷
      • Buenos Aires、阿根廷
        • Atencion Integral en Reumatologa
      • Buenos Aires、阿根廷
        • Rheumatology OMI
      • Cordoba、阿根廷
        • Instituto Reumatologico
      • Quilmes、阿根廷
        • Instituto Médico CER
      • San Fernando、阿根廷
        • Instituto de Asistencia Reumatologia Integral
      • Tucuman、阿根廷
        • Centro Medico Privado de Reumatologia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：GLPG0634 50 毫克每日一次
参与者在第 1 至 12 周期间口服 GLPG0634 50 mg 胶囊，QD。有反应的参与者（在 TJC68 和 SJC66 上至少有 20% 的改善）继续服用 50 mg QD，而无反应者在第 13 周期间被重新随机分配至 100 mg QD到 24。
药品：GLPG0634
GLPG0634 胶囊。
实验性的：GLPG0634 100 毫克每日一次
参与者在第 1 至 24 周期间每天口服 GLPG0634 100 毫克胶囊。
药品：GLPG0634
GLPG0634 胶囊。
实验性的：GLPG0634 200 毫克每日一次
参与者在第 1 至 24 周期间每天口服 GLPG0634 200 毫克胶囊。
药品：GLPG0634
GLPG0634 胶囊。
安慰剂比较：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.
药品：安慰剂
安慰剂胶囊。
实验性的：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.
药品：GLPG0634
GLPG0634 胶囊。
实验性的：GLPG0634 50 mg BID
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
药品：GLPG0634
GLPG0634 胶囊。
实验性的：GLPG0634 100 mg BID
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
药品：GLPG0634
GLPG0634 胶囊。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
在第 12 周达到美国风湿病学会 (ACR) 20 响应的参与者百分比
大体时间：第 12 周
美国风湿病学会 (ACR) 反应是衡量多种疾病评估标准改善情况的指标。 ACR20 响应定义为：1) 在 SJC66 中从基线改善 ≥ 20%，和 2) 在投标 TJC68 中从基线改善 ≥ 20%，以及 3) 在以下 5 项中至少有 3 项从基线改善 ≥ 20%： 1. 疼痛视觉模拟量表 (VAS)（取自健康评估问卷 - 残疾指数 [HAQ-DI]），2. 患者对疾病活动性 VAS 的整体评估，3. 医生对疾病活动性 VAS 的整体评估，4. 总 HAQ -DI 分数和 5. CRP。 使用无反应者归因（即，为了归因缺失反应，参与者被假定为无反应者）。
第 12 周

次要结果测量

结果测量
措施说明
大体时间
在第 24 周达到 ACR20 响应的参与者百分比
大体时间：第 24 周
ACR20 反应定义为：1) SJC66 中较基线改善 ≥ 20%，以及 2) TJC68 中较基线改善 ≥ 20%，以及 3) 以下 5 项中的至少 3 项较基线改善 ≥ 20%：1.疼痛 VAS（取自 HAQ-DI），2. 患者对疾病活动 VAS 的整体评估，3. 医生对疾病活动 VAS 的整体评估，4. 总 HAQ-DI 评分，和 5. CRP。 使用无应答者归因。
第 24 周
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Galapagos NV

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年7月17日

初级完成 (实际的)

2015年2月18日

研究完成 (实际的)

2015年5月14日

研究注册日期

首次提交

2013年6月26日

首先提交符合 QC 标准的

2013年6月27日

首次发布 (估计)

2013年6月28日

研究记录更新

最后更新发布 (实际的)

2020年11月17日

上次提交的符合 QC 标准的更新

2020年10月26日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

安慰剂的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Djibouti

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅