--- title: Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2) nct_id: NCT01894516 overall_status: COMPLETED phase: PHASE2 sponsor: Galapagos NV study_type: INTERVENTIONAL primary_condition: Rheumatoid Arthritis countries: United States, Argentina, Australia, Austria, Bulgaria, Chile, Colombia, Germany, Guatemala, Hungary, Latvia, Mexico, Moldova, New Zealand, Poland, Romania, Russia, Spain, Ukraine canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01894516.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01894516" ct_last_update_post_date: 2020-12-16 last_seen_at: "2026-05-12T06:40:17.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2) **Official Title:** Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone **NCT ID:** [NCT01894516](https://clinicaltrials.gov/study/NCT01894516) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 287 - **Lead Sponsor:** Galapagos NV - **Conditions:** Rheumatoid Arthritis - **Start Date:** 2013-10-08 - **Completion Date:** 2015-05-29 - **CT.gov Last Update:** 2020-12-16 ## Brief Summary * Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) 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 of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated. ## Detailed Description * Treatment duration was 24 weeks in total. * However, at Week 12, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment until Week 24. * Participants in the other groups maintained their randomized treatment until Week 24. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * male or female subjects who are ≥18 years of age on the day of signing informed consent, * 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 shown an inadequate response in terms of either lack of efficacy or toxicity to MTX, * have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period. Exclusion Criteria: * current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening, * current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; 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. ``` ## Arms - **Placebo** (PLACEBO_COMPARATOR) — Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24. - **GLPG0634 50 mg QD** (EXPERIMENTAL) — Participants 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. - **GLPG0634 100 mg QD** (EXPERIMENTAL) — Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. - **GLPG0634 200 mg QD** (EXPERIMENTAL) — Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. ## Interventions - **GLPG0634** (DRUG) — GLPG0634 capsules. - **Placebo** (DRUG) — Placebo capsules. ## Primary Outcomes - **Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12** _(time frame: 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). ## Secondary Outcomes - **Percentage of Participants Achieving an ACR20 Response at Week 24** _(time frame: Week 24)_ - **Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24** _(time frame: Weeks 1, 2, 4, 8, 12, and 24)_ - **Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24** _(time frame: Weeks 1, 2, 4, 8, 12, and 24)_ - **ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24** _(time frame: 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** _(time frame: Weeks 1, 2, 4, 8, 12, and 24)_ - **Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24** _(time frame: Weeks 4, 8, 12, and 24)_ - **Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24** _(time frame: 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** _(time frame: 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** _(time frame: 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** _(time frame: Baseline and Weeks 4, 12, and 24)_ ## Locations (82) - Artho Care, Arthritis Care & Research P.C., Gilbert, Arizona, United States - Arizona Arthritis & Rheumatology Research PLLC, Mesa, Arizona, United States - Arizona Arthritis Rheum Res, Phoenix, Arizona, United States - Little Rock Diagnostic Clinic, Little Rock, Arkansas, United States - C.V. Mehta MD Medical Corp., Hemet, California, United States - Center for Innovative Therapy Division of Rheumatology, UCSD, La Jolla, California, United States - Desert Medical Advances, Palm Desert, California, United States - Infosphere Clinical Research, Inc., West Hills, California, United States - Lovelace Scientific Resources, Venice, Florida, United States - Arthritis Center of North GA, Gainesville, Georgia, United States - The Arthritis Center, Springfield, Illinois, United States - Klein and Associates MD, Hagerstown, Maryland, United States - Private practice, Lansing, Michigan, United States - Arthritis Center of Reno, Reno, Nevada, United States - New Jersey Physicians, LLC, Clifton, New Jersey, United States - Health research of Oklahoma, Oklahoma City, Oklahoma, United States - Altoona Center Clin Research, Duncansville, Pennsylvania, United States - Low Country Rheumatology, PA, Charleston, South Carolina, United States - Arthritis Clinic, Jackson, Tennessee, United States - Austin Rheumatology Research PA, Austin, Texas, United States - Pioneer Research Solutions Inc, Houston, Texas, United States - Centro de Investigaciones Medicas Lanus, Lanus, Argentina - Instituto Centralizado de Asistencia e investigacion Clinica Integral, Rosario, Argentina - Centro Médico Privado de Reumatología, San Miguel de Tucumán, Argentina - Royal Prince Alfred Hospital, Camperdown, Australia - Princess Alexandra Hospital, Woolloongabba, Australia - Rheumazentrum Favoriten, Vienna, Austria - "Multiprofile Hospital for Active Treatment - Kaspela" LTD, Plovdiv, Bulgaria - Clinic of Rheumatology MHAT, Sofia, Bulgaria - Hospital Regional "Guillermo Grant Benavente", Concepción, Chile - Private Office, Temuco, Chile - Fundación del Caribe para la Investigación Biomédica BIOS, Barranquilla, Colombia - Centro Integral de Reumatologia SAS, Bogotá, Colombia - Cirei Sas, Bogotá, Colombia - Idearg S.A.S., Bogotá, Colombia - Medicity S.A.S., Bucaramanga, Colombia - Preventive Care Ltda, Chía, Colombia - Schlossparkklinik - Akad. Lehrkrankenhaus Charite, Berlin, Germany - Schwerpunktpraxis fuer Rheumatologie, Hamburg, Germany - Clinica Médica Especializada en Medicina Interna, Guatemala City, Guatemala - Reuma S.A., Guatemala City, Guatemala - Reuma-Centro, Guatemala City, Guatemala - DRC, Balatonfüred, Hungary - Qualiclinic Ltd, Budapest, Hungary - Revita Clinic, Budapest, Hungary - Csolnoky Ferenc County Hospital, Veszprém, Hungary - L. Atikes doktorats, Liepāja, Latvia - "Bruninieku" Polyclinic, Riga, Latvia - Arké Estudios Clínicos S.A. de C.V., México, Mexico - Centro Medico Dalinde, México, Mexico - Clinstile, S.A. de C.V., México, Mexico - Mexico Centre for Clinical Research, México, Mexico - Hospital Universitario, Monterrey, Mexico - Hospital de Especialidades, Oaxaca City, Mexico - IMSP Institutul de Cardiologie, Chisinau, Moldova - North Shore hospital, Auckland, New Zealand - Timaru Rheumatology Studies, Timaru, New Zealand - Silesiana Centrum Medyczne, Bytom, Poland - Centrum Kliniczno, Elblag, Poland - Medica Pro Familia Sp. z o.o. S.K.A., Katowice, Poland - Nowomed, Krakow, Poland - Nzoz "Dobry Lekarz", Krakow, Poland - NZOZ Przychodnia Lekarska "Eskulap", Skierniewice, Poland - NZOZ Medicus Bonus, Środa Wielkopolska, Poland - AMED Medical Center, Warsaw, Poland - Ars Rheumatica Sp. Z.o.o., Warsaw, Poland - Wojewodzki Szpital Specjalistyczny we Wroclawiu, Wroclaw, Poland - Ianuli Med Consult SRL, Bucharest, Romania - Sana Medical Center, Bucharest, Romania - Spitalul Clinic Sfanta Maria, Bucharest, Romania - Emergency County Hospital, Galati, Romania - Orenburg State Medical Academy, Orenburg, Russia - GUZ "Regional Clinical Hospital", Saratov, Russia - Vladimir Reg Clin Hosp, Vladimir, Russia - Hospital General Elche, Elche, Spain - Consorci Sanitari Parc Tauli, Sabadell, Spain - CICEC S.L.P Hospital Ntra.Sra.de la Esperanza, Santiago de Compostela, Spain - V. Gusak Institute of Urgent and Recovery Surgery, Donetsk, Ukraine - City Hospital #8, Kharkiv, Ukraine - Municipal Hospital, Kherson, Ukraine - Central Outpatient Hospital of Deanyanskyy Distric, Kiev, Ukraine - Regional Clinical Hospital, Vinnytsia, Ukraine ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.artho care, arthritis care & research p.c.|gilbert|arizona|united states` — added _(2026-05-12)_ - `locations.arizona arthritis & rheumatology research pllc|mesa|arizona|united states` — added _(2026-05-12)_ - `locations.arizona arthritis rheum res|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.little rock diagnostic clinic|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.c.v. mehta md medical corp.|hemet|california|united states` — added _(2026-05-12)_ - `locations.center for innovative therapy division of rheumatology, ucsd|la jolla|california|united states` — added _(2026-05-12)_ - `locations.desert medical advances|palm desert|california|united states` — added _(2026-05-12)_ - `locations.infosphere clinical research, inc.|west hills|california|united states` — added _(2026-05-12)_ - `locations.lovelace scientific resources|venice|florida|united states` — added _(2026-05-12)_ - `locations.arthritis center of north ga|gainesville|georgia|united states` — added _(2026-05-12)_ - `locations.the arthritis center|springfield|illinois|united states` — added _(2026-05-12)_ - `locations.klein and associates md|hagerstown|maryland|united states` — added _(2026-05-12)_ - `locations.private practice|lansing|michigan|united states` — added _(2026-05-12)_ - `locations.arthritis center of reno|reno|nevada|united states` — added _(2026-05-12)_ - `locations.new jersey physicians, llc|clifton|new jersey|united states` — added _(2026-05-12)_ - `locations.health research of oklahoma|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.altoona center clin research|duncansville|pennsylvania|united states` — added _(2026-05-12)_ - `locations.low country rheumatology, pa|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.arthritis clinic|jackson|tennessee|united states` — added _(2026-05-12)_ - `locations.austin rheumatology research pa|austin|texas|united states` — added _(2026-05-12)_ - `locations.pioneer research solutions inc|houston|texas|united states` — added _(2026-05-12)_ - `locations.centro de investigaciones medicas lanus|lanus||argentina` — added _(2026-05-12)_ - `locations.instituto centralizado de asistencia e investigacion clinica integral|rosario||argentina` — added _(2026-05-12)_ - `locations.centro médico privado de reumatología|san miguel de tucumán||argentina` — added _(2026-05-12)_ - `locations.royal prince alfred hospital|camperdown||australia` — added _(2026-05-12)_ - `locations.princess alexandra hospital|woolloongabba||australia` — added _(2026-05-12)_ - `locations.rheumazentrum favoriten|vienna||austria` — added _(2026-05-12)_ - `locations."multiprofile hospital for active treatment - kaspela" ltd|plovdiv||bulgaria` — added _(2026-05-12)_ - `locations.clinic of rheumatology mhat|sofia||bulgaria` — added _(2026-05-12)_ - `locations.hospital regional "guillermo grant benavente"|concepción||chile` — added _(2026-05-12)_ - `locations.private office|temuco||chile` — added _(2026-05-12)_ - `locations.fundación del caribe para la investigación biomédica bios|barranquilla||colombia` — added _(2026-05-12)_ - `locations.centro integral de reumatologia sas|bogotá||colombia` — added _(2026-05-12)_ - `locations.cirei sas|bogotá||colombia` — added _(2026-05-12)_ - `locations.idearg s.a.s.|bogotá||colombia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01894516.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01894516* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*