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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003655-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.
Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib Darwin 1 | Experimental | Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved. |
|
| Filgotinib Darwin 2 | Experimental | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Administered as Oral Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-Emergent Adverse Events | An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date. | From First dose to Week 437 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count 68 (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.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthro, Arthritis Care & Research | Gilbert | Arizona | United States | |||
| Arizona Arthritis & Rheumatology Research PLLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Genovese MC, Kavanaugh A, Winthrop K, et al. Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 84 Data from a Phase 2b Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). | ||
| Result | Kavanaugh A, Westhovens R, Winthrop K, et al. Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). | ||
| Result | R. Westhovens, R. Alten, K. Winthrop, et al. Long term safety of filgotinib in the treatment of rheumatoid arthritis: week 108 data from a phase 2b open-label extension study. [abstract]. Ann Rheum Dis. 2018;77 (suppl 2) | ||
| Result | Kavanaugh A, Genovese MC, Winthrop K, et al. Rheumatoid Arthritis Treatment with Filgotinib: Week 132 Safety Data from a Phase 2b Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). | ||
| 33526618 |
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Qualified external researchers may request IPD for clinical trials that support an approved indication in the EU and the US for which Galapagos is the Marketing Authorisation / New Drug Application Holder, with a marketing authorisation date on or after January 1, 2021 and for which the summary results have been published on ClinicalTrials.gov (CT.gov) and/or the EU Clinical Trials Register (EU CTR). For clinical trials of newly approved compounds or indications the IPD can be requested at earliest 6 months after the EMA and FDA approval. The study last patient last visit (LPLV) must have occurred at least 18 months prior to the request.
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Participants from DARWIN1 or DARWIN2 were rolled over into this extension study. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
Participants with moderately to severely active rheumatoid arthritis were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Filgotinib Darwin 1 | Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2021 | Jan 4, 2024 |
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| Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | The ACR response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was 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 VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR50 Response: NRI | The ACR response was a measurement of improvement in multiple disease assessment criteria. 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.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR50 Response: OC | The ACR response was a measurement of improvement in multiple disease assessment criteria. 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.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR70 Response: NRI | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 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.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR70 Response: OC | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 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.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| ACR N% Improvement (ACR-N) Response: OC | ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS [taken from the HAQ-DI], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA [using a VAS on a scale of 0 (very well) to 100 (very poor)] and hsCRP using the formula: DAS28(CRP) = 0.56 * Square root [SQRT] (TJC28) + 0.28 * SQRT(SJC28) + 0.36 * Ln(CRP+1) + 0.014 * SGA + 0.96 and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement. | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement. | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement. | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | 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. | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR/EULAR Remission: NRI | A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Percentage of Participants Achieving ACR/EULAR Remission: OC | A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1. | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
| Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:
These scales were from 0 to 100 with higher scores indicating a better quality of life. | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 |
| Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:
These scales were from 0 to 100 with higher scores indicating a better quality of life. | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 |
| Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from "4" before being added to obtain a total score. 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 less fatigue. A positive change from baseline indicated better quality of life. | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 |
| Mesa |
| Arizona |
| United States |
| C.V. Mehta MD Medical Corp. | Hemet | California | United States |
| Desert Medical Advances | Palm Desert | California | United States |
| RASF Clinical Research Center | Boca Raton | Florida | United States |
| Millenium Research | Ormond Beach | Florida | United States |
| Lovelace Scientific Resources | Venice | Florida | United States |
| Springfield Clinic | Springfield | Illinois | United States |
| Klein and Associates MD, PA | Hagerstown | Maryland | United States |
| Physicians East | Greenville | North Carolina | United States |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | United States |
| Low County Rheumatology PA | Charleston | South Carolina | United States |
| West Tennessee Research Institute | Jackson | Tennessee | United States |
| Austin Rheumatology Research PA | Austin | Texas | United States |
| Pioneer Research Solutions Inc | Houston | Texas | United States |
| Atencion Integral en Reumatologa | Buenos Aires | Argentina |
| CER Intituto Medico | Buenos Aires | Argentina |
| Organizacion Medica de Investigaciones (OMI) | Buenos Aires | Argentina |
| Instituto Reumatologico Strusberg | Córdoba | Argentina |
| CIMeL Centro dee Investigacion Medico Lanus | Lanus | Argentina |
| Instituto CAICI | Rosario | Argentina |
| Instituto de Asistencia Reumatologia Integral - IARI | San Fernando | Argentina |
| Centro Médico Privado de Reumatologia | San Miguel de Tucumán | Argentina |
| Flinders Medical Centre | Bedford Park | Flinders Drive, South Australia | Australia |
| Monash Medical Centre | Clayton | Victoria | Australia |
| Princess Alexandra Hospital | Woolloongabba | Australia |
| Cliniques Universitaires St-Luc | Brussels | Belgium |
| UZ Leuven | Leuven | Belgium |
| University "Multiprofile Hospital for Active Treatment - Kaspela" LTD | Plovdiv | Bulgaria |
| Multiprofile Hospital for Active Treatment - Ruse | Rousse | Bulgaria |
| Diagnostic Consultative Center "Sveta Anna" LTD | Sofia | Bulgaria |
| National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases | Sofia | Bulgaria |
| University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic | Sofia | Bulgaria |
| Hospital Regional "Guillermo Grant Benavente" | Santiago | Chile |
| Prosalud | Santiago | Chile |
| Someal SA | Santiago | Chile |
| Centro de Investigacion Clinica del Sur | Temuco | Chile |
| Consulta Privada Dra. Ponce | Temuco | Chile |
| Medicity S.A.S. | Bucaramanga | Santander Department | Colombia |
| Circaribe S.A.S | Barranquilla | Colombia |
| Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM) | Bogotá | 110221 | Colombia |
| Riesgo De Fractura Cayre Ips7 | Bogotá | 110221 | Colombia |
| Idearg Sas | Bogotá | Colombia |
| Preventive Care SAS | Cundinamarca | Colombia |
| Hospital Pablo Tobon Uribe | Medellín | Colombia |
| Revmatologie S.R.O | Brno | Czechia |
| Revmatologicka a interni ambulance | Kladno | Czechia |
| Revmatologicka ambulance | Praha-Nusle | Czechia |
| PV-Medical S.R.O. | Zlín | Czechia |
| Hospitaux de Hautepierre | Strasbourg | France |
| Schlossparkklinik - Akad. Lehrkrankenhaus Charite | Berlin | Germany |
| MVZ Rheumatologie and Autoimmun Medizin HH GmbH | Hamburg | Germany |
| Centro Clinico | Guatemala City | Guatemala |
| Clinica de Especialidades Medicas | Guatemala City | Guatemala |
| Clinica Medica Especializada en Reumatologia | Guatemala City | Guatemala |
| Clinica Medica | Guatemala City | Guatemala |
| Reuma S.A. | Guatemala City | Guatemala |
| Reuma-Centro | Guatemala City | Guatemala |
| Gyogyszervizs galo Kozpont Kft | Balatonfüred | Hungary |
| QualiClinic Kft. | Budapest | Hungary |
| Reumatologiai Kft. | Budapest | Hungary |
| Markhot Ferenc Hospital, Rheumatology | Eger | Hungary |
| Csolnoky Ferenc Hospital, Rheumatology | Veszprém | Hungary |
| Carmel Medical Center | Haifa | Israel |
| Rambam Medical Center | Haifa | Israel |
| Ltd M&M Centr | Adazi | Latvia |
| SIA Arijas Ancane's Family Doctor | Baldone | Latvia |
| Daugavpils Regional Hospital | Daugavpils | Latvia |
| L. Atikes doktorats | Liepāja | Latvia |
| 'Bruninieku' polyclinic | Riga | Latvia |
| Centro de Estudios de Investigacion Basica y Clinica, SC | Guadalajara | Mexico |
| Centro Medico Dalinde | Mexico City | Mexico |
| Arke Estudios Clinicos S.A. de C.V. | México | Mexico |
| Clinstile, S.A. de C.V. | México | Mexico |
| Hospital General de México | México | Mexico |
| Hospital Universitario José E. Gonzalez | Monterrey | Mexico |
| OSMO | Oaxaca City | Mexico |
| IMSP Institutul de Cardiologie | Chisinau | Moldova |
| Waikato Hospital | Hamilton | New Zealand |
| Timaru Rheumatology Studies | Timaru | New Zealand |
| NZOZ Osteo-Medic s.c. | Bialystok | Poland |
| Centrum Medyczne Silesiana Sp. Z.o.o. | Bytom | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | Poland |
| Centrum Medyczne Plejady | Krakow | Poland |
| NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie | Krakow | Poland |
| Specjalistyczne Centrum Medyczne Nowomed | Krakow | Poland |
| NZOZ Przychodnia Lekarska "Eskulap" | Skierniewice | Poland |
| Powiatowy Zaklad Opieki Zdrowotnej w Starachowicach | Starachowice | Poland |
| NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz | Torun | Poland |
| AMED Medical Center | Warsaw | Poland |
| Rheumatica Sp. Z.o.o. | Warsaw | Poland |
| Spitalul Clinic Sfanta Maria | Bucharest | Romania |
| Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati | Galati | Romania |
| First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health | Moscow | Russia |
| Scientific Research Institute of Rheumatology | Moscow | Russia |
| City Clinical Hospital #5 | Nizhny Novgorod | Russia |
| GBOU VPO Orenburg State Medical University | Orenburg | Russia |
| Ryazan State Medical University | Ryazan | Russia |
| City Hospital #26 | Saint Petersburg | Russia |
| Regional Clinical Hospital | Saratov | Russia |
| Vladimir Regional State Instituion of Healthcare | Vladimir | Russia |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | Spain |
| Sanatorio Nuestra Señora de la Esperanza | A Coruña | Spain |
| Hospital Parc Tauli | Sabadell | Spain |
| Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13 | Kharkiv | Ukraine |
| Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology | Kharkiv | Ukraine |
| L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine | Kharkiv | Ukraine |
| Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin | Kherson | Ukraine |
| Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv | Kiev | Ukraine |
| Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city | Kyiv | Ukraine |
| Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department | Vinnytsia | Ukraine |
| Result |
| Kavanaugh A, Westhovens RR, Winthrop KL, Lee SJ, Tan Y, An D, Ye L, Sundy JS, Besuyen R, Meuleners L, Stanislavchuk M, Spindler AJ, Greenwald M, Alten R, Genovese MC. Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs. J Rheumatol. 2021 Aug;48(8):1230-1238. doi: 10.3899/jrheum.201183. Epub 2021 Feb 1. |
| 39884731 | Derived | Westhovens R, Winthrop KL, Kavanaugh A, Greenwald M, Dagna L, Cseuz R, Besuyen R, de Vries D, Modgill V, Le LH, Genovese MC, Emery P, Verschueren P, Alten R. Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study. RMD Open. 2025 Jan 30;11(1):e004857. doi: 10.1136/rmdopen-2024-004857. |
| 37747626 | Derived | 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. |
| 36205910 | Derived | 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. |
| FG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
| Male US Participants |
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| COMPLETED |
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| NOT COMPLETED |
|
|
The Safety Analysis Set included all participants who enrolled in the extension study and received at least one dose of study drug. As prespecified in the protocol, data was collected and analyzed based on their originating parent study I.e. DARWIN 1 and DARWIN 2.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Filgotinib Darwin 1 | Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved. |
| BG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Treatment-Emergent Adverse Events | An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date. | Safety Analysis Set. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | participants | From First dose to Week 437 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) | The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count 68 (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.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP). | The Full Analysis Set (FAS) included all participants who enrolled in the extension study and received at least one dose of study drug. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR20 Response: Observed Case (OC) | The ACR response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was 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 VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR50 Response: NRI | The ACR response was a measurement of improvement in multiple disease assessment criteria. 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.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP. | FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR50 Response: OC | The ACR response was a measurement of improvement in multiple disease assessment criteria. 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.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR70 Response: NRI | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 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.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP. | FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR70 Response: OC | The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 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.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | ACR N% Improvement (ACR-N) Response: OC | ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS [taken from the HAQ-DI], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | percentage of improvement | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC | The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA [using a VAS on a scale of 0 (very well) to 100 (very poor)] and hsCRP using the formula: DAS28(CRP) = 0.56 * Square root [SQRT] (TJC28) + 0.28 * SQRT(SJC28) + 0.36 * Ln(CRP+1) + 0.014 * SGA + 0.96 and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | score on a scale | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Change From Core Baseline in Simple Disease Activity Index (SDAI): OC | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | score on a scale | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC | The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | score on a scale | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC | 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. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR/EULAR Remission: NRI | A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1. | FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Percentage of Participants Achieving ACR/EULAR Remission: OC | A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Number | percentage of participants | Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408 |
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| Secondary | Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC | The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:
These scales were from 0 to 100 with higher scores indicating a better quality of life. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | score on a scale | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 |
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| Secondary | Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC | The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:
These scales were from 0 to 100 with higher scores indicating a better quality of life. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | score on a scale | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 |
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| Secondary | Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC | FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from "4" before being added to obtain a total score. 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 less fatigue. A positive change from baseline indicated better quality of life. | FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2. | Posted | Mean | Standard Deviation | score on a scale | Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384 |
|
From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filgotinib Darwin 1 | Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved. | 8 | 497 | 84 | 497 | 386 | 497 |
| EG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. | 8 | 242 | 48 | 242 | 189 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Leiomyosarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Soft tissue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Colpocele | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Acquired diaphragmatic eventration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Caplan's syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Electrocardiogram Q wave abnormal | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
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| Brain contusion | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lens dislocation | Eye disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Wrist deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Meningitis meningococcal | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood cholesterol increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Mycobacterium tuberculosis complex test positive | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Systematic Assessment |
|
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15 342900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2019 | Jan 4, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 |
| Filgotinib Darwin 2 |
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|
| Filgotinib Darwin 2 |
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|
| OG001 | Filgotinib Darwin 2 | Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval. Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion. |
|
|