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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01888874
Other study ID # GLPG0634-CL-203 (DARWIN1)
Secondary ID 2012-003635-31
Status Completed
Phase Phase 2
First received
Last updated
Start date July 17, 2013
Est. completion date May 14, 2015

Study information

Verified date October 2020
Source Galapagos NV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

- 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.


Recruitment information / eligibility

Status Completed
Enrollment 599
Est. completion date May 14, 2015
Est. primary completion date February 18, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GLPG0634
GLPG0634 capsules.
Placebo
Placebo capsules.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Galapagos NV

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Chile,  Colombia,  Czechia,  France,  Germany,  Guatemala,  Hungary,  Israel,  Latvia,  Mexico,  Moldova, Republic of,  New Zealand,  Poland,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) = 20% improvement from baseline in SJC66, and 2) = 20% improvement from baseline in tender TJC68, and 3) = 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [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 (ie, to impute a missing response, the participant was assumed to be a non-responder). Week 12
Secondary Percentage of Participants Achieving an ACR20 Response at Week 24 ACR20 response was defined as: 1) = 20% improvement from baseline in SJC66, and 2) = 20% improvement from baseline in TJC68, and 3) = 20% 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. Week 24
Secondary Percentage of Participants Achieving an ACR50 Response at 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
Secondary Percentage of Participants Achieving an ACR70 Response at 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
Secondary ACR N% Improvement (ACR-N) Response at 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
Secondary 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 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
Secondary Percentage of Participants Achieving ACR/EULAR Remission at 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
Secondary Change From Baseline in Simplified Disease Activity Index (SDAI) at 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
Secondary Change From Baseline in Clinical Disease Activity Index (CDAI) at 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
Secondary Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at 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
Secondary Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at 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
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