AzTrials
AzTrials

Rheumatoid ArthritisPhase 2DARWIN1NCT01888874

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

A Phase 2 study testing GLPG0634 in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 142 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
GLPG0634
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
599 participants
Where
142 sitesin 22 countries
Study dates
17 Jul 2013to 14 May 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

142 sites in 22 countries.

142 sites in 22 countries

United States28 sites

  • Austin Rheumatology Research PA

    Austin, Texas

  • RASF Clinical Research Center

    Boca Raton, Florida

  • Mountain State Clinical Research

    Clarksburg, West Virginia

  • Arthritis Centers of Texas

    Dallas, Texas

  • Altoona Center Clinical Research

    Duncansville, Pennsylvania

  • Arthritis Treatment Center

    Frederick, Maryland

  • Arthritis Center of North GA

    Gainesville, Georgia

  • Artho Care, Arthritis Care & Research P.C.

    Gilbert, Arizona

  • Physicians East

    Greenville, North Carolina

  • Klein and Associates MD

    Hagerstown, Maryland

  • C.V. Mehta MD Medical Corporation

    Hemet, California

  • Pioneer Research Solutions Inc

    Houston, Texas

  • Rheumatology Associates of North Alabama, PC

    Huntsville, Alabama

  • Center for Innovative TherapyDivision of Rheumatology, UCSD

    La Jolla, California

  • Private practice

    Lansing, Michigan

  • Idaho Arthritis Center

    Meridian, Idaho

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma

  • Millennium Research

    Ormond Beach, Florida

  • Desert Medical Advances

    Palm Desert, California

  • Arizona Arthritis & Rheumatology Research PLLC

    Phoenix, Arizona

  • Mayo Clinic

    Rochester, Minnesota

  • Seattle Rheumatology Associates, PLLC

    Seattle, Washington

  • The Arthritis Center

    Springfield, Illinois

  • Lovelace Scientific Resources

    Venice, Florida

  • Crossroads Clinical Research, LLC

    Victoria, Texas

  • Desert Valley Medical Center

    Victorville, California

  • Infosphere Clinical Research, Inc.

    West Hills, California

  • Professional Research Network of Kansas

    Wichita, Kansas

Other trials in United States

Poland12 sites

  • NZOZ Osteo-Medic s.c.

    Bialystok

  • Silesiana Centrum Medyczne

    Bytom

  • Medica Pro Familia Sp. z o.o. S.K.A.

    Katowice

  • Centrum Medyczne Plejady

    Krakow

  • Nowomed

    Krakow

  • Nzoz "Dobry Lekarz"

    Krakow

  • NZOZ Przychodnia Lekarska "Eskulap"

    Skierniewice

  • NS ZOZ Medicus Bonus

    Środa Wielkopolska

  • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach

    Starachowice

  • NZOZ Nasz Lekarz

    Torun

  • AMED Medical Center

    Warsaw

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu

    Wroclaw

Other trials in Poland

Colombia9 sites

  • Centro Integral de Reumatologia de Caribe

    Barranquilla

  • Fundación del caribe para la investigación medica Fundación BIOS

    Barranquilla

  • Centro Integral de Reumatologia e Inmunologia SAS

    Bogotá

  • Cirei Sas

    Bogotá

  • Idearg S.A.S.

    Bogotá

  • Medicity S.A.S.

    Bucaramanga

  • Clinica de Arthritis Temprana S.A.S.

    Cali

  • Preventive Care SAS

    Cundinamarca

  • Hospital Pablo Tobon Uribe

    Medellín

Other trials in Colombia

Ukraine8 sites

  • City Hospital #5

    Donetsk

  • V. Gusak Institute of Urgent and Recovery Surgery

    Donetsk

  • City Hospital #13

    Kharkiv

  • City Hospital #8

    Kharkiv

  • Government Institution

    Kharkiv

  • Central Outpatient Hospital of Deanyanskyy Distric

    Kiev

  • Central regional polyclinic of Pechersk District

    Kyiv

  • Municipal Institution Lutsk City Clinical Hospital

    Lutsk

Other trials in Ukraine

Hungary7 sites

  • DRC

    Balatonfüred

  • Budai Irgalmasrendi Korhaz

    Budapest

  • Qualiclinic Ltd

    Budapest

  • Revita Clinic

    Budapest

  • Markhot Ferenc Korhaz

    Eger

  • Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly

    Gyula

  • Csolnoky Ferenc County Hospital

    Veszprém

Other trials in Hungary

Mexico7 sites

  • Centro de Estudios de Investigacion Basica y Clinica, SC

    Guadalajara

  • Arké Estudios Clínicos

    México

  • Clinstile, S.A. de C.V.

    México

  • Hospital General de México

    México

  • Accelerium Clinical Research

    Monterrey

  • Hospital Universitario José E. González

    Monterrey

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

    San Luis Potosí City

Other trials in Mexico

Russia7 sites

  • I.M. Sechenov First Moscow State Medical University

    Moscow

  • Research Institute of Rheumatology RAMS

    Moscow

  • State University of Medicine and Dentistry

    Moscow

  • City Clinical Hospital 5

    Nizhny Novgorod

  • Ryazan State Medical University

    Ryazan

  • City Hospital # 26

    Saint Petersburg

  • Vladimir Reg Clin Hosp

    Vladimir

Other trials in Russia

Argentina6 sites

  • Atencion Integral en Reumatologa

    Buenos Aires

  • Rheumatology OMI

    Buenos Aires

  • Instituto Reumatologico

    Córdoba

  • Instituto Medico CER

    Quilmes

  • Instituto de Asistencia Reumatologia Integral

    San Fernando

  • Centro Médico Privado de Reumatología

    San Miguel de Tucumán

Other trials in Argentina

Belgium6 sites

  • Cliniques Universitaires St-Luc

    Brussels

  • Hospital Brugmann

    Brussels

  • Rheuma Instituut

    Hasselt

  • AZ Groeninge

    Kortrijk

  • UZ Leuven

    Leuven

  • CHU de Liège

    Liège

Other trials in Belgium

Bulgaria6 sites

  • "Multiprofile Hospital for Active Treatment - Kaspela" LTD

    Plovdiv

  • MHAT Ruse AD

    Rousse

  • Clinic of Rheumatology MHAT

    Sofia

  • Diagnostic Consultative Center "Sveta Anna" LTD

    Sofia

  • National Transport Hospital "Tsar Boris" III

    Sofia

  • Rheumatology Clinic

    Sofia

Other trials in Bulgaria

Chile6 sites

  • Hospital Regional "Guillermo Grant Benavente"

    Concepción

  • Instituto Terapias Oncologicas Providencia

    Santiago

  • Prosalud

    Santiago

  • Someal SA

    Santiago

  • Centro de Investigacion Clínica del Sur Freire

    Temuco

  • Private Office

    Temuco

Other trials in Chile

Guatemala6 sites

  • Centro Medico

    Guatemala City

  • Clinica de Especialidades Medicas

    Guatemala City

  • Clinica Medica Especializada en Reumatologia

    Guatemala City

  • Clinica Medica

    Guatemala City

  • Reuma S.A.

    Guatemala City

  • Reuma-Centro

    Guatemala City

Other trials in Guatemala

Spain6 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • Hospital Reina Sofa

    Córdoba

  • Hospital General Universitario de Elche

    Elche

  • Hospital Universitario de Mostoles

    Móstoles

  • Consorci Sanitari Parc Tauli

    Sabadell

  • Hospital Infanta Luisa

    Seville

Other trials in Spain

Czechia5 sites

  • Revmatologie S.R.O

    Brno

  • Ambulance Revmatologie a Interniho Lekarstvi

    Kladno

  • Revmatologicka ambulance

    Praha-Nusle

  • Medical Plus, s.r.o.

    Uherské Hradiště

  • PV-Medical

    Zlín

Other trials in Czechia

Germany5 sites

  • Charite Mitte, Rheumatologie Neue Therapien

    Berlin

  • Schlossparkklinik - Akad. Lehrkrankenhaus Charite

    Berlin

  • Klinikum Goethe-Universität

    Frankfurt

  • Schwerpunktpraxis fuer Rheumatologie

    Hamburg

  • Rheumazentrum Ruhrgebiet

    Herne

Other trials in Germany

Latvia5 sites

  • M&M Centre Ltd.

    Adazi

  • Meda D

    Daugavplis

  • L. Atikes doktorats

    Liepāja

  • "Bruninieku" polyclinic

    Riga

  • Arija's Ancane's Family Doctor

    Riga

Other trials in Latvia

Australia4 sites

  • Royal Prince Alfred Hospital

    Camperdown

  • Monash Medical Centre

    Clayton

  • Repatriation General Hospital

    Daw Park

  • Princess Alexandra Hospital

    Woolloongabba

Other trials in Australia

Israel3 sites

  • Carmel Medical Center

    Haifa

  • Rambam Medical Center

    Haifa

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

New Zealand3 sites

  • North Shore hospital

    Auckland

  • Waikato Hospital

    Hamilton

  • Timaru Rheumatology Studies

    Timaru

Other trials in New Zealand

Austria1 site

  • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J

    Vienna

Other trials in Austria

France1 site

  • Hopitaux universitaires de Strasbourg

    Strasbourg

Other trials in France

Moldova1 site

  • IMSP Institutul de Cardiologie

    Chisinau

Other trials in Moldova

About this study

Official title: 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.

Read the detailed 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.
Being tested
GLPG0634, Placebo
Keywords
Methotrexate inadequate responders
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG0634Drug

    GLPG0634 capsules.

  • PlaceboDrug

    Placebo capsules.

Study groups in NCT01888874
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo
GLPG0634 50 mg QDExperimentalParticipants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Receives: Drug: GLPG0634
GLPG0634 100 mg QDExperimentalParticipants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Receives: Drug: GLPG0634
GLPG0634 200 mg QDExperimentalParticipants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Receives: Drug: GLPG0634
GLPG0634 25 mg BIDExperimentalParticipants 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.
Receives: Drug: GLPG0634
GLPG0634 50 mg BIDExperimentalParticipants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Receives: Drug: GLPG0634
GLPG0634 100 mg BIDExperimentalParticipants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Receives: Drug: GLPG0634

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 12

Secondary outcomes (10)

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Weeks 1, 2, 4, 8, 12, and 24

  3. 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.

    Measured: Weeks 1, 2, 4, 8, 12, and 24

  4. 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).

    Measured: Weeks 1, 2, 4, 8, 12, and 24

  5. 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.

    Measured: Weeks 1, 2, 4, 8, 12, and 24

  6. 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.

    Measured: Weeks 2, 4, 8, 12, and 24

  7. 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.

    Measured: Baseline and Weeks 1, 2, 4, 8, 12, and 24

  8. 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.

    Measured: Baseline and Weeks 1, 2, 4, 8, 12, and 24

  9. 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.

    Measured: Baseline and Weeks 4, 12, and 24

  10. 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.

    Measured: Baseline and Weeks 4, 12, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study start17 Jul 2013
  3. Primary completion18 Feb 2015
  4. Study completion14 May 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888874
Sponsor's protocol ID
GLPG0634-CL-203 (DARWIN1)
Other IDs
2012-003635-31
Acronym
DARWIN1
Status last verified
Oct 2020
First submitted
26 Jun 2013
Last updated
17 Nov 2020
Data monitoring committee
Yes

Publications

  • Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.

    PubMed 37747626

  • Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

    PubMed 36205910

  • Tarrant JM, Galien R, Li W, Goyal L, Pan Y, Hawtin R, Zhang W, Van der Aa A, Taylor PC. Filgotinib, a JAK1 Inhibitor, Modulates Disease-Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials. Rheumatol Ther. 2020 Mar;7(1):173-190. doi: 10.1007/s40744-019-00192-5. Epub 2020 Jan 7.

    PubMed 31912462

  • Westhovens R, Taylor PC, Alten R, Pavlova D, Enriquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017 Jun;76(6):998-1008. doi: 10.1136/annrheumdis-2016-210104. Epub 2016 Dec 19.

    PubMed 27993829

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLPG0634 in people with Rheumatoid Arthritis, run by Lakefront Biotherapeutics NV at 142 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Poland, Colombia, Ukraine, Hungary and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888874, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in