acronym: CheckMate 577

summary: The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

ReferenceCitation: Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. Erratum In: N Engl J Med. 2023 Feb 16;388(7):672.

repository_institution: Ghent University - Ghent University Academic Bibliography

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Pacific Hematology Oncology Associates
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title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Romania
Belgium
China
Peru
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


type: Other Identifier

title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

acronym: GARNET

summary: This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Patnaik A, Weiss GJ, Rasco DW, Blaydorn L, Mirabella A, Beeram M, Guo W, Lu S, Danaee H, McEachern K, Im E, Sachdev JC. Safety, antitumor activity, and pharmacokinetics of dostarlimab, an anti-PD-1, in patients with advanced solid tumors: a dose-escalation phase 1 trial. Cancer Chemother Pharmacol. 2022 Jan;89(1):93-103. doi: 10.1007/s00280-021-04358-3. Epub 2021 Nov 8.

ReferenceCitation: Zhang XT, Chen H, Shao W, Zhongping JL, Melham M, Lu S.A Competitive Ligand Binding Assay to Measure Antidrug Antibodies Against Dostarlimab (TSR-042).2021; DOI: 10.1186/s41120-021-00039-w

doi: zhang

ReferenceCitation: Patterson M, Beausang LA, Rup B, Bowsher R, Krug K, Gunn G, Melham M, Lu S.A Bridging Assay for Detection and Characterization of Anti-Drug Antibodies to Dostarlimab, a New Anti-PD-1 Therapeutic Monoclonal Antibody .2021;7(11) DOI: DOI 10.1186/s41120-021-00045-y

doi: patterson

ReferenceCitation: Kumar S, Ghosh S, Sharma G, Wang Z, Kehry MR, Marino MH, Neben TY, Lu S, Luo S, Roberts S, Ramaswamy S, Danaee H, Jenkins D. Preclinical characterization of dostarlimab, a therapeutic anti-PD-1 antibody with potent activity to enhance immune function in in vitro cellular assays and in vivo animal models. MAbs. 2021 Jan-Dec;13(1):1954136. doi: 10.1080/19420862.2021.1954136.

ReferenceCitation: Oaknin A, Gilbert L, Tinker AV, Brown J, Mathews C, Press J, Sabatier R, O'Malley DM, Samouelian V, Boni V, Duska L, Ghamande S, Ghatage P, Kristeleit R, Leath C III, Guo W, Im E, Zildjian S, Han X, Duan T, Veneris J, Pothuri B. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) or proficient/stable (MMRp/MSS) endometrial cancer: interim results from GARNET-a phase I, single-arm study. J Immunother Cancer. 2022 Jan;10(1):e003777. doi: 10.1136/jitc-2021-003777.

ReferenceCitation: Kristeleit R, Mathews C, Redondo A, Boklage S, Hanlon J, Im E, Brown J. Patient-reported outcomes in the GARNET trial in patients with advanced or recurrent mismatch repair-deficient/microsatellite instability-high endometrial cancer treated with dostarlimab. Int J Gynecol Cancer. 2022 Aug 16;32(10):1250-7. doi: 10.1136/ijgc-2022-003492. Online ahead of print.

ReferenceCitation: Kuchimanchi M, Dabrowski C, Lu S, Melhem M. Dostarlimab, an anti-programmed death-1 monoclonal antibody, does not cause QT prolongation in patients with solid tumours: A concentration-QT analysis. Br J Clin Pharmacol. 2023 Jul;89(7):2272-2282. doi: 10.1111/bcp.15700. Epub 2023 Mar 20.

ReferenceType: derived

ReferenceCitation: Moreno V, Roda D, Pikiel J, Trigo J, Bosch-Barrera J, Drew Y, Kristeleit R, Hiret S, Bajor DL, Cruz P, Beck JT, Ghosh S, Dabrowski C, Antony G, Duan T, Veneris J, Zografos E, Subramanian J. Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial. Clin Lung Cancer. 2022 Nov;23(7):e415-e427. doi: 10.1016/j.cllc.2022.05.013. Epub 2022 May 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Oaknin A, Tinker AV, Gilbert L, Samouelian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical activity and safety of the anti-PD-1 monoclonal antibody dostarlimab for patients with recurrent or advanced dMMR endometrial cancer. Future Oncol. 2021 Oct 1;17(29):3781-3785. doi: 10.2217/fon-2021-0598. Epub 2021 Aug 24.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nd

license_normalized: cc-by-nd

version: publishedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ReferenceCitation: Oaknin A, Tinker AV, Gilbert L, Samouelian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):1766-1772. doi: 10.1001/jamaoncol.2020.4515.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: Tesaro, Inc.

location_country:
Italy
Poland
United Kingdom
Argentina
Denmark
Brazil
Mexico
United States
Korea, Republic of
Spain
Czechia
Canada
France

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer

summary: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

status: Active, not recruiting

design_allocation: Randomized

enrollment_type: Actual

ReferenceCitation: Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5. Erratum In: Lancet Oncol. 2021 Nov;22(11):e472.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Argentina
Australia
Japan
Turkey
Czechia
France
Hungary
Denmark
United States
Belgium
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: University of Southern Florida School of Medicine

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Central Roentgenoradiological Research Institute MZ RF

intervention_type: Drug


acronym:
Fixed dose combination versus free combination of tiotropium and olodaterol in COPD

 Comparaison de l’association fixe du tiotropium et de l’olodatérol versus association libre en BPCO

lead_sponsor: Boehringer Ingelheim

summary:
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.

location_facility: Ordination Dr. Robert Voves, 8330 Feldbach

location_facility: Verboten Kopriva Renata - Private practice, Litija

location_facility: Univ. Clinic of Respiratory and Allergic Diseases, Golnik

status: Completed

title: A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)

source: euctr

study_completion_date_type: Actual

location_country: Finland Slovenia Denmark Austria France

status_simplified: Completed


lead_sponsor: pharmaand GmbH

summary:
NOTE: The study data was transferred to zr pharma& following the divestment of Panobinostat to pharma&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis.

The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression.

Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons.

Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks.

All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.

ReferenceCitation: Laubach JP, Schjesvold F, Mariz M, Dimopoulos MA, Lech-Maranda E, Spicka I, Hungria VTM, Shelekhova T, Abdo A, Jacobasch L, Polprasert C, Hajek R, Illes A, Wrobel T, Sureda A, Beksac M, Goncalves IZ, Blade J, Rajkumar SV, Chari A, Lonial S, Spencer A, Maison-Blanche P, Moreau P, San-Miguel JF, Richardson PG. Efficacy and safety of oral panobinostat plus subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (PANORAMA 3): an open-label, randomised, phase 2 study. Lancet Oncol. 2021 Jan;22(1):142-154. doi: 10.1016/S1470-2045(20)30680-X. Epub 2020 Dec 7.

location_facility: Albert Schweitzer ziekenhuis, Hematology

title: A Multicenter, Randomized, Open-label Phase 2 Study Evaluating the Safety and Efficacy of Three Different Regimens of Oral Panobinostat in Combination With Subcutaneous Bortezomib and Oral Dexamethasone in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Who Have Been Previously Exposed to Immunomodulatory Agents

location_country:
Germany
Poland
Australia
Brazil
Thailand
Turkey
Czechia
Canada
France
Portugal
Hungary
United States
Lebanon
Belgium
Italy
Norway
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation
Sweden


title: Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary:
The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

lead_sponsor: Innate Pharma

sponsor_collaborators:
Innate Pharma
AstraZeneca

location_country:
United States
France

location_facility: Washington University School of Medicine

location_facility: Institut Regional du Cancer de Montpellier

location_facility: University of California, Moores Cancer Center

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center


title: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

acronym: PATINA

summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.

ReferenceCitation: Welch HG, Gorski DH, Albertsen PC. Trends in Metastatic Breast and Prostate Cancer--Lessons in Cancer Dynamics. N Engl J Med. 2015 Oct 29;373(18):1685-7. doi: 10.1056/NEJMp1510443. No abstract available.

ReferenceCitation: Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.

ReferenceCitation: Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Heeson S, Clark E, Ross G, Benyunes MC, Cortes J; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. doi: 10.1056/NEJMoa1413513.

oa_colors: green other

evidence: open (via free article)

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

repositories_concat: PubMed Central;trepo.tuni.fi

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

ReferenceCitation: Sherr CJ, Roberts JM. CDK inhibitors: positive and negative regulators of G1-phase progression. Genes Dev. 1999 Jun 15;13(12):1501-12. doi: 10.1101/gad.13.12.1501. No abstract available.

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ReferenceCitation: Weinberg RA. The retinoblastoma protein and cell cycle control. Cell. 1995 May 5;81(3):323-30. doi: 10.1016/0092-8674(95)90385-2. No abstract available.

ReferenceCitation: Harper JW, Adami GR, Wei N, Keyomarsi K, Elledge SJ. The p21 Cdk-interacting protein Cip1 is a potent inhibitor of G1 cyclin-dependent kinases. Cell. 1993 Nov 19;75(4):805-16. doi: 10.1016/0092-8674(93)90499-g.

ReferenceCitation: Koff A, Ohtsuki M, Polyak K, Roberts JM, Massague J. Negative regulation of G1 in mammalian cells: inhibition of cyclin E-dependent kinase by TGF-beta. Science. 1993 Apr 23;260(5107):536-9. doi: 10.1126/science.8475385.

ReferenceCitation: Polyak K, Kato JY, Solomon MJ, Sherr CJ, Massague J, Roberts JM, Koff A. p27Kip1, a cyclin-Cdk inhibitor, links transforming growth factor-beta and contact inhibition to cell cycle arrest. Genes Dev. 1994 Jan;8(1):9-22. doi: 10.1101/gad.8.1.9.

ReferenceCitation: Toyoshima H, Hunter T. p27, a novel inhibitor of G1 cyclin-Cdk protein kinase activity, is related to p21. Cell. 1994 Jul 15;78(1):67-74. doi: 10.1016/0092-8674(94)90573-8.

ReferenceCitation: Lukas J, Parry D, Aagaard L, Mann DJ, Bartkova J, Strauss M, Peters G, Bartek J. Retinoblastoma-protein-dependent cell-cycle inhibition by the tumour suppressor p16. Nature. 1995 Jun 8;375(6531):503-6. doi: 10.1038/375503a0.

ReferenceCitation: Medema RH, Herrera RE, Lam F, Weinberg RA. Growth suppression by p16ink4 requires functional retinoblastoma protein. Proc Natl Acad Sci U S A. 1995 Jul 3;92(14):6289-93. doi: 10.1073/pnas.92.14.6289.

ReferenceCitation: Lee RJ, Albanese C, Fu M, D'Amico M, Lin B, Watanabe G, Haines GK 3rd, Siegel PM, Hung MC, Yarden Y, Horowitz JM, Muller WJ, Pestell RG. Cyclin D1 is required for transformation by activated Neu and is induced through an E2F-dependent signaling pathway. Mol Cell Biol. 2000 Jan;20(2):672-83. doi: 10.1128/MCB.20.2.672-683.2000.

ReferenceCitation: Lane HA, Beuvink I, Motoyama AB, Daly JM, Neve RM, Hynes NE. ErbB2 potentiates breast tumor proliferation through modulation of p27(Kip1)-Cdk2 complex formation: receptor overexpression does not determine growth dependency. Mol Cell Biol. 2000 May;20(9):3210-23. doi: 10.1128/MCB.20.9.3210-3223.2000.

ReferenceCitation: Yu Q, Sicinska E, Geng Y, Ahnstrom M, Zagozdzon A, Kong Y, Gardner H, Kiyokawa H, Harris LN, Stal O, Sicinski P. Requirement for CDK4 kinase function in breast cancer. Cancer Cell. 2006 Jan;9(1):23-32. doi: 10.1016/j.ccr.2005.12.012.

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ReferenceCitation: Yang C, Ionescu-Tiba V, Burns K, Gadd M, Zukerberg L, Louis DN, Sgroi D, Schmidt EV. The role of the cyclin D1-dependent kinases in ErbB2-mediated breast cancer. Am J Pathol. 2004 Mar;164(3):1031-8. doi: 10.1016/S0002-9440(10)63190-2.

ReferenceCitation: Landis MW, Pawlyk BS, Li T, Sicinski P, Hinds PW. Cyclin D1-dependent kinase activity in murine development and mammary tumorigenesis. Cancer Cell. 2006 Jan;9(1):13-22. doi: 10.1016/j.ccr.2005.12.019.

ReferenceCitation: Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.

ReferenceCitation: Witkiewicz AK, Cox DW, Rivadeneira D, Ertel AE, Fortina P, Schwartz GF, Knudsen ES. The retinoblastoma tumor suppressor pathway modulates the invasiveness of ErbB2-positive breast cancer. Oncogene. 2014 Jul 24;33(30):3980-91. doi: 10.1038/onc.2013.367. Epub 2013 Oct 14.

ReferenceCitation: Roberts PJ, Bisi JE, Strum JC, Combest AJ, Darr DB, Usary JE, Zamboni WC, Wong KK, Perou CM, Sharpless NE. Multiple roles of cyclin-dependent kinase 4/6 inhibitors in cancer therapy. J Natl Cancer Inst. 2012 Mar 21;104(6):476-87. doi: 10.1093/jnci/djs002. Epub 2012 Feb 1.

ReferenceCitation: Goel S, Wang Q, Watt AC, Tolaney SM, Dillon DA, Li W, Ramm S, Palmer AC, Yuzugullu H, Varadan V, Tuck D, Harris LN, Wong KK, Liu XS, Sicinski P, Winer EP, Krop IE, Zhao JJ. Overcoming Therapeutic Resistance in HER2-Positive Breast Cancers with CDK4/6 Inhibitors. Cancer Cell. 2016 Mar 14;29(3):255-269. doi: 10.1016/j.ccell.2016.02.006.

ReferenceCitation: Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3. Erratum In: Lancet Oncol. 2016 Apr;17 (4):e136. Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Gonzalez-Angulo AM, Kirshner JJ, Krop I, Levinson J, Modi S, Patt DA, Perez EA, Perlmutter J, Winer EP, Lin NU. Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jul 1;32(19):2100-8. doi: 10.1200/JCO.2013.54.0955. Epub 2014 May 5.

ReferenceCitation: Cardoso F, Costa A, Norton L, Senkus E, Aapro M, Andre F, Barrios CH, Bergh J, Biganzoli L, Blackwell KL, Cardoso MJ, Cufer T, El Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano SH, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin UN, Mayer M, Merjaver SD, Nordstrom EB, Pagani O, Partridge A, Penault-Llorca F, Piccart MJ, Rugo H, Sledge G, Thomssen C, Van't Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)dagger. Ann Oncol. 2014 Oct;25(10):1871-1888. doi: 10.1093/annonc/mdu385. Epub 2014 Sep 18. No abstract available.

ReferenceCitation: Lipton A, Ali SM, Leitzel K, Demers L, Harvey HA, Chaudri-Ross HA, Brady C, Wyld P, Carney W. Serum HER-2/neu and response to the aromatase inhibitor letrozole versus tamoxifen. J Clin Oncol. 2003 May 15;21(10):1967-72. doi: 10.1200/JCO.2003.09.098.

ReferenceCitation: Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ Jr, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol. 2003 Aug 1;21(15):2889-95. doi: 10.1200/JCO.2003.02.018.

ReferenceCitation: Chan A, Martin M, Untch M, Gil MG, Guillem-Porta V, Wojtukiewicz M, Kellokumpu-Lehtinen P, Sommer HL, Georgoulias V, Battelli N, Pawlicki M, Aubert D, Bourlard T, Gasmi J, Villanova G, Petruzelka L; Navelbine Herceptin Project. Vinorelbine plus trastuzumab combination as first-line therapy for HER 2-positive metastatic breast cancer patients: an international phase II trial. Br J Cancer. 2006 Oct 9;95(7):788-93. doi: 10.1038/sj.bjc.6603351. Epub 2006 Sep 12.

ReferenceCitation: Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.

ReferenceCitation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

ReferenceType: result

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

ReferenceCitation: Finn, R.S., et al., PALOMA-2: Primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ER+/HER2- advanced breast cancer (ABC). ASCO Meeting Abstracts, 2016. 34(15_suppl): p. 507.

ReferenceCitation: Paridaens R, Dirix L, Lohrisch C, Beex L, Nooij M, Cameron D, Biganzoli L, Cufer T, Duchateau L, Hamilton A, Lobelle JP, Piccart M; European Organization for the Research and Treatment of Cancer (EORTC)- Investigational Drug Branch for Breast Cancer (IDBBC). Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer. Ann Oncol. 2003 Sep;14(9):1391-8. doi: 10.1093/annonc/mdg362.

ReferenceCitation: Pfizer, Inc. Palbociclib (PD-0332991): Investigator's Brochure. N.p.: Pfizer, 2015. Print.

ReferenceCitation: Peddi PF, Slamon DJ. Frontiers in HER2-positive breast cancer in 2020. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):48-52. doi: 10.1097/GCO.0000000000000677.

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Alliance Foundation Trials, LLC.

collaborators: Breast Cancer Trials, Australia and New Zealand

location_country:
Germany
Italy
Portugal
New Zealand
Australia
United States
Spain
France

location_facility: Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

location_facility: Univ. Klinikum Oldenburg AÖR Hämatologie/Onkologie

location_facility: Auckland City Hospital Cancer and Blood Research

location_facility: Michigan Cancer Research Consortium (St. Joseph Mercy Hospital

location_facility: First Health of the Carolinas Cancer Center

location_facility: UKSH, Klinik für Gynäkologie und Geburtshilfe

location_facility: Institut de Cancérologie de l'Ouest, site Paul Papin

location_facility: U.O. Oncologia AOU Arcispedale Sant'Anna

location_facility: Vidia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG Frauenklinik

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: St. Vincent's Hospital, Sydney Kinghorn Cancer Centre

location_facility: Peter MacCallum Cancer Centre, Royal Melbourne Hospital

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Metro-Minnesota NCI Community Oncology Research Program

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Hospital Regional Universitario de Málaga

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: The University of Chicago Medical Center

location_facility: Praxis Prof. Nitz im Brustzentrum Niederrhein

location_facility: The Valley Hospital, Okonite Research Center

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Universitario Fundación Jiménez Díaz


acronym: ODYSSEY DM-Insulin

lead_sponsor: Sanofi

summary:
Primary Objectives:

To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy.
To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin.

Secondary Objective:

To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

oa_host_type: repository

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Ray KK, Del Prato S, Muller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Imperial College London - Spiral

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: RWTH Aachen - RWTH Publications

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Leiter LA, Cariou B, Muller-Wieland D, Colhoun HM, Del Prato S, Tinahones FJ, Ray KK, Bujas-Bobanovic M, Domenger C, Mandel J, Samuel R, Henry RR. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017 Dec;19(12):1781-1792. doi: 10.1111/dom.13114. Epub 2017 Oct 10.

evidence: open (via crossref license)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

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title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
United States
Spain
France


lead_sponsor: Pfizer

summary: A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

ReferenceCitation: Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

version: submittedVersion

repositories_concat: UCL Discovery

repositories_institution: University College London - UCL Discovery

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Orszagos Onkologiai Intezet, Gyogyszertar

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Medizinische Universitat Graz, LKH-Univ. Klinikum Graz

location_facility: Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Fondazione Poliambulanza Istituto Ospedelario

location_facility: Fairview Hospital Moll Pavilion Cancer Center

location_facility: Universitatsspital Zurich, Universitares Herzzentrum Zurich

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Department of Obstetrics and Gynecology, Haukeland University Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: University of California, Irvine/UC Irvine Health

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"

location_facility: State Budgetary Healthcare Institution of Nizhegorogsky region

location_facility: Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika

location_facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

location_facility: Institut Catala d'Oncologia - Hospital Duran y Reynalds

location_facility: The University of Kansas Cancer Center, CCP - North

location_facility: Poliambulatorio Specialistico Villa Salute

location_facility: US Oncology Investigational Products Center

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z

location_facility: The University of Kansas Clinical Research Center

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch

location_facility: Keimyung University Dongsan Medical Center

location_facility: The University of Pennsylvania Health System

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Humanitas, Unita Operativa di Cardiologia 2

location_facility: Azienda Unita Sanitaria Locale di Piacenza

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont

location_facility: Ambulatorio dott. Francesco Cavanna, Medico Chirurgo

location_facility: Hillcrest Hospital Hirsch Cancer Center Pharmacy

location_facility: National Defense Medical College Hospital

location_facility: State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center

location_facility: Oncology Pharmacy McGill University Health Centre

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w

location_facility: Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,

location_facility: Saitama Medical University International Medical Center

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna

location_facility: Servizio Sanitario Regionale Emilia-Romagna

location_facility: Universitaetsspital Zurich, Klinik fuer Gynakologie

location_facility: Guy's & St. Thomas' NHS Foundation Trust

location_facility: Fairview Hospital Moll Pavilion Pharmacy

location_facility: lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta

location_facility: Norton Cancer Institute, Brownsboro Hospital Campus

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Regione Lombardia, A O Istituti Ospitalieri di Cremona

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology

location_facility: Clinical Trial Pharmacy, National Cheng Kung University Hospital

location_facility: Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Center of Hope at Renown Regional Medical Center

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Nottingham University Hospital NHS Trust

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Vseobecna fakultni nemocnice v Praze, Neurologicka klinika

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: The Christie Hospital NHS Foundation Trust

location_facility: State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary

location_facility: Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center

location_facility: Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy

location_facility: McGill University Health Centre - Glen Site

location_facility: State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare

location_facility: Epic Pharmacy,Newcastle Private Hospital

location_facility: Clinical Trial Pharmacy, Taipei Veterans General Hospital

location_facility: Universitatsspital Zurich, Clinical Trials Center

location_facility: National Cancer Centre Singapore Pharmacy

location_facility: Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"

location_facility: Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie

location_facility: Spire Healthcare Limited (St. Anthony's Hospital)

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre

location_facility: Investigational Drug Services, University of Pennsylvania

location_facility: Clinical Trial Pharmacy, Mackay Memorial Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Nippon Medical School Musashikosugi Hospital

location_facility: Congregazione delle Suore Infermiere dell'Addolorata

location_facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna

location_facility: State Budgetary Healthcare Institution "Clinical oncology dispensary #1"

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Texas Oncology -Fort Worth Cancer Center

title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Ireland
Poland
Australia
Japan
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

acronym: DIVERSITYLTE

summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

status: Terminated

lead_sponsor: Galapagos NV

sponsor_collaborators:
Galapagos NV
Gilead Sciences

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Japan
Croatia
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
Sri Lanka
Iceland
Ukraine
India
Romania
Belgium
Malaysia
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel

location_facility: Hyogo College of Medicine College Hospital

location_facility: Ohmori Toshihide gastro-intestinal Clinic

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: Center for Interventional Endoscopy - Florida Hospital

location_facility: Illinois Gastroenterology Group - Gurnee

location_facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals

location_facility: Universiti Kebangsaan Malaysia Medical Center

location_facility: GZA Ziekenhuizen, campus Sint-Vincentius

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Centrul Medical Tuculanu, Gastroenterologie

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Gastroenterology Associates of Tidewater

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: University of Louisville, Clinical Trials Unit

location_facility: The University of Chicago Medical Center (Clinic)

location_facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Clinical Research Center Sp. z o.o. Medic-R Sp.k.

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Hospital Universitario Central de Asturias

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Southern California Research Center, Inc.

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

location_facility: Coral Sea Clinical Research Institute (Mackay)

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)

location_facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

location_facility: University of Mississippi Medical Center

location_facility: Department of Surgery, B.J. Government Medical College & Sassoon General Hospital

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Baylor College of Medicine - McNair Campus

location_facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

location_facility: UOC di Gastroenterologia ed Endoscopia Digestiva

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Premier Medical Group of the Hudson Valley

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: Hutt Valley District Health Board - Hutt Valley Hospital

location_facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: The University of Texas Health Science Center at Houston

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Washington University School of Medicine

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Shiga University of Medical Science Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: UOC Medicina Interna a Gastroenterologia

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Lakeshore Hospital and Research Centre Ltd

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: S.L. Raheja Hospital (A Fortis Associate)

location_facility: Gastroenterology Research of San Antonio

location_facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: Delta Health Care/ Ponderas Academic Hospital

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Medical Center - Complete Medical Solutions OOD

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

location_facility: University of Colorado Denver and Hospital

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC

location_facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN

location_facility: Seth G.S. Medical College & KEM Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: Szent Margit Korhaz, Gasztroenterológiai Osztály

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Wellcome Trust HRB Clinical Research Facility

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: Hospital Universitario de Gran Canaria "Dr. Negrin"

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

location_facility: Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Digestive Health Specialists Of The Southeast

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department

location_facility: Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II

location_facility: Saitama Medical Center, Saitama Medical University

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: New York University School of Medicine / NYU Gastroenterology Associates

location_facility: London Health Sciences Centre - University Hospital

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

status_simplified: Unknown


title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

summary:
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Japan
Croatia
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
Sri Lanka
Iceland
Ukraine
India
Romania
Belgium
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel

location_facility: Hyogo College of Medicine College Hospital

location_facility: Ohmori Toshihide gastro-intestinal Clinic

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

location_facility: Illinois Gastroenterology Group - Gurnee

location_facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals

location_facility: Universiti Kebangsaan Malaysia Medical Center

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: Center for Interventional Endoscopy - AdventHealth Orlando

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Centrul Medical Tuculanu, Gastroenterologie

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego

location_facility: State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"

location_facility: Spitalul Clinic Colentina, Gastroenterologie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Gastroenterology Associates of Tidewater

location_facility: Great Lakes Gastroenterology Research, LLC,

location_facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Hospital Universitario Central de Asturias

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Southern California Research Center, Inc.

location_facility: Unidade Local de Saude do Alto Minho, EPE

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Coral Sea Clinical Research Institute (Mackay)

location_facility: University Medical Center Groningen (UMCG)

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: University of Mississippi Medical Center

location_facility: Department of Surgery, B.J. Government Medical College & Sassoon General Hospital

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

location_facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main

location_facility: Centre d'Investigation Clinique - CHU Hotel-Dieu

location_facility: UOC di Gastroenterologia ed Endoscopia Digestiva

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.

location_facility: Victoria Hospital, Bangalore Medical College and Research Institute

location_facility: Premier Medical Group of the Hudson Valley

location_facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: Hutt Valley District Health Board - Hutt Valley Hospital

location_facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie

location_facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit

location_facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: The University of Texas Health Science Center at Houston

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Texas Digestive Disease Consultants (IP Shipment)

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Washington University School of Medicine

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Shiga University of Medical Science Hospital

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Asian Institute of Gastroenterology Pvt Ltd

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: S.R.Kalla Memorial Gastro.&General Hospital

location_facility: Gastroenterology Research of San Antonio

location_facility: General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki

location_facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Lakeshore Hospital and Research Centre Ltd.

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: Delta Health Care/ Ponderas Academic Hospital

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Medical Center - Complete Medical Solutions OOD

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

location_facility: University of Colorado Denver and Hospital

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: Digestive Health Specialists of the Southeast

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC

location_facility: Gastroplus Digestive Disease Centre Pvt Ltd

location_facility: Medstar Georgetown University Hospital (Patient Exams)

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: Szent Margit Korhaz, Gasztroenterológiai Osztály

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: University of Louisville, School of Medicine

location_facility: Wellcome Trust HRB Clinical Research Facility

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: Hospital Universitario de Gran Canaria "Dr. Negrin"

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Kitasato University Hospital, THE KITASATO INSTITUTE

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Vestre Viken Hospital Trust, Baerum Hospital

location_facility: Complejo Hospitalario Universitario de Pontevedra

location_facility: New York University School of Medicine/NYU Gastroenterology Associates

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: Indiana University Health University Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: Medical corporation Ryowakai, Hamamatsu South Hospital


acronym: SELECTIONLTE

summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).

location_facility: Hyogo College of Medicine College Hospital

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: GZA Ziekenhuizen, campus Sint-Vincentius

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Gastroenterology Associates of Tidewater

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Hospital Universitario Central de Asturias

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

location_facility: Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

location_facility: PCR-Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Kitasato University Hospital,THE KITASATO INSTITUTE

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.

location_facility: Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>

location_facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico

location_facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

location_facility: Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety

location_facility: Colo-proctology Center Matsushima Clinic

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: The University of Texas Health Science Center at Houston

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Washington University School of Medicine

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Shiga University of Medical Science Hospital

location_facility: Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Gastroenterology Research of San Antonio

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Centrum Innowacyjnych Terapii Sp. z o.o.

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Digestive Health Specialists Of The Southeast

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Santa Familia, Centrum Badan, Profilaktyki i Leczenia

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

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