acronym: Phase 3 trial of first line etoposide/platinum with or without pembrolizumab in ES-SCLC(KEYNOTE-604)

lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy.

The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.

ReferenceType: result

ReferenceCitation: Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csoszi T, Cheema PK, Rodriguez-Abreu D, Wollner M, Yang JC, Mazieres J, Orlandi FJ, Luft A, Gumus M, Kato T, Kalemkerian GP, Luo Y, Ebiana V, Pietanza MC, Kim HR; KEYNOTE-604 Investigators. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020 Jul 20;38(21):2369-2379. doi: 10.1200/JCO.20.00793. Epub 2020 May 29.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: North Shore University Health System ( Site 1216)

location_facility: Universitaetsspital Zuerich ( Site 1404)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0803)

location_facility: Complejo Hospitalario Universitario de A Coruna ( Site 0953)

location_facility: Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)

location_facility: CHRU de Lille - Hopital Albert Calmette ( Site 0353)

location_facility: Canterbury Regional Cancer & Blood Services ( Site 0701)

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)

location_facility: National Taiwan University Hospital ( Site 1001)

location_facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0955)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0203)

location_facility: Kingston Health Sciences Centre ( Site 0155)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1211)

location_facility: Massachusetts General Hospital ( Site 1203)

location_facility: Hospital Universitari Vall d Hebron ( Site 0951)

location_facility: Florence Nightingale Krankenhaus ( Site 0413)

location_facility: Niigata Cancer Center Hospital ( Site 0610)

location_facility: Sunnybrook Research Institute ( Site 0151)

location_facility: Birmingham Heartlands Hospital ( Site 1162)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)

location_facility: Hiroshima University Hospital ( Site 0604)

location_facility: Universitaetsklinikum Tuebingen ( Site 0404)

location_facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)

location_facility: Ege Universitesi Tıp Fakultesi ( Site 1052)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)

location_facility: Rush University Medical Center ( Site 1215)

location_facility: Severance Hospital Yonsei University Health System ( Site 0903)

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)

location_facility: CISSS-CA Hotel Dieu de Levis ( Site 0154)

location_facility: Baptist Health Medical Group Oncology, LLC ( Site 8000)

location_facility: Duke University Medical Center ( Site 1214)

location_facility: Minnesota Oncology Hematology, PA ( Site 8001)

location_facility: Chaim Sheba Medical Center. ( Site 0501)

location_facility: Philipps-Universitat Marburg ( Site 0414)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)

location_facility: CISSS de la Monteregie-Centre ( Site 0152)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)

location_facility: Nova Scotia Health Authority ( Site 0157)

location_facility: National Cancer Center Hospital East ( Site 0613)

location_facility: Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0958)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8004)

location_facility: Municipal Clinical Oncology Center ( Site 0802)

location_facility: SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)

location_facility: St. Jerome Medical Research Inc. ( Site 0160)

location_facility: Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)

location_facility: Taipei Veterans General Hospital ( Site 1002)

location_facility: Wakayama Medical University Hospital ( Site 0612)

location_facility: Chi Mei Medical Center Liuying ( Site 1006)

location_facility: Osaka International Cancer Institute ( Site 0616)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1061)

location_facility: Medical Park Izmir Hospital ( Site 1051)

location_facility: Orszagos Onkologiai Intezet ( Site 0453)

location_facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 0454)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 0757)

location_facility: Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 1210)

location_facility: China Medical University Hospital. ( Site 1003)

location_facility: Dana-Farber Cancer Institute [Boston] ( Site 1201)

location_facility: CHU Nantes - Hopital Laennec ( Site 0363)

location_facility: Clinica Universidad Catolica del Maule ( Site 0208)

location_facility: Evangelische Lungenklinik Berlin ( Site 0403)

location_facility: Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0354)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)

location_facility: Bon Secours St. Francis Health Sytem ( Site 1212)

location_facility: St James s University Hospital ( Site 1161)

location_facility: Southern Medical Day Care Centre ( Site 0001)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1229)

location_facility: Instituto Nacional del Cancer ( Site 0207)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0617)

location_facility: Inje University Haeundae Paik Hospital ( Site 0905)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0460)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0457)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0614)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0952)

location_facility: Beth Israel Deaconess Medical Center ( Site 1206)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0615)

location_facility: St Vincents Hospital Melbourne ( Site 0005)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0161)

location_facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0206)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1059)

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)

location_facility: St Vincents University Hospital ( Site 1456)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0606)

location_facility: Belgorod Regional Oncology Dispensary ( Site 0804)

location_facility: Taichung Veterans General Hospital ( Site 1007)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)

location_facility: SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)

location_facility: Institut de Cancerologie Jean-Godinot ( Site 0351)

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)

location_facility: National Cheng Kung University Hospital ( Site 1004)

location_facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)

title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Japan
Turkey
Chile
Canada
France
Hungary
Switzerland
United States
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

status: Active, not recruiting

title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Denmark
Switzerland
United States
Romania
China
Peru
Italy
Norway
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

acronym: APEKS-NP

summary: The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nordmann P, Shields RK, Doi Y, Takemura M, Echols R, Matsunaga Y, Yamano Y. Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials. Microb Drug Resist. 2022 Apr;28(4):398-407. doi: 10.1089/mdr.2021.0180. Epub 2022 Jan 24.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Skaar EP, Echols R, Matsunaga Y, Menon A, Portsmouth S. Iron serum levels and iron homeostasis parameters in patients with nosocomial pneumonia treated with cefiderocol: post hoc analysis of the APEKS-NP study. Eur J Clin Microbiol Infect Dis. 2022 Mar;41(3):467-476. doi: 10.1007/s10096-021-04399-9. Epub 2022 Jan 13.

evidence: open (via crossref license)

publisher_dissemination: Springer-Nature

ReferenceCitation: Wenzler E, Butler D, Tan X, Katsube T, Wajima T. Pharmacokinetics, Pharmacodynamics, and Dose Optimization of Cefiderocol during Continuous Renal Replacement Therapy. Clin Pharmacokinet. 2022 Apr;61(4):539-552. doi: 10.1007/s40262-021-01086-y. Epub 2021 Nov 18. Erratum In: Clin Pharmacokinet. 2022 Jul;61(7):1069.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Wunderink RG, Matsunaga Y, Ariyasu M, Clevenbergh P, Echols R, Kaye KS, Kollef M, Menon A, Pogue JM, Shorr AF, Timsit JF, Zeitlinger M, Nagata TD. Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2021 Feb;21(2):213-225. doi: 10.1016/S1473-3099(20)30731-3. Epub 2020 Oct 12.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: Shionogi

location_country:
Germany
Japan
Czechia
Canada
Serbia
France
Hungary
United States
Latvia
Ukraine
Belgium
Estonia
Puerto Rico
Philippines
Spain
Taiwan
Georgia
Russian Federation
Israel

status_simplified: Completed


lead_sponsor: Astellas Pharma Global Development, Inc.

summary: The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

location_facility:
Site JP81012
Site HU36003
Site GR30009
Site FR33001
Site JP81014
Site KR82013
Site TW88603
Site RS38102
Site US10025
Site GB44019
Site JP81011
Site GR30004
Site IT39002
Site IT39008
Site GB44007
Site KR82014
Site GB44020
Site US10017
Site PL48007
Site TW88605
Site PT35106
Site PL48002
Site KR82008
Site KR82012
Site FR33007
Site JP81004
Site US10029
Site JP81002
Site DE49001
Site SE46003
Site FR33009
Site DE49008
Site PT35101
Site KR82003
Site GB44006
Site US10007
Site JP81018
Site DK45002
Site FR33004
Site BR55002
Site JP81023
Site KR82005
Site IT39004
Site RO40005
Site CA15001
Site PL48001
Site TW88604
Site IT39005
Site US10012
Site CA15003
Site GR30010
Site KR82009
Site JP81017
Site IT39011
Site IL97205
Site JP81010
Site FR33002
Site GB44015
Site CZ42001
Site SE46002
Site JP81024
Site JP81009
Site US10030
Site IT39010
Site ES34009
Site GB44004
Site FR33014
Site FR33008
Site JP81025
Site KR82006
Site GB44002
Site GR30007
Site GB44018

title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Poland
Japan
Brazil
Czechia
Canada
Serbia
France
Portugal
Hungary
Denmark
United States
Romania
Italy
United Kingdom
Sweden
Korea, Republic of
Spain
Greece
Taiwan
Israel

ipd_sharing: Yes


intervention_type: Other

summary: The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.

location_facility: Organizacion Medica De Investigacion S.A. (Omi)

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

location_facility: Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South

location_facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome

location_country:
Germany
Italy
Argentina
Australia
Brazil
Japan
Mexico
Sweden
United States
Korea, Republic of
Czechia
Puerto Rico
France


lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective.

Secondary Objectives:

To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
To evaluate the efficacy of dupilumab in improving sense of smell.
To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan).
To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery.
To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [ERD]).
To evaluate residual effect in follow up.
To evaluate the safety of dupilumab in participants with bilateral NP.
To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.

ReferenceCitation: Peters AT, Soler ZM, Kern RC, Heffler E, Maspero JF, Crampette L, Fujieda S, Lane AP, Zhang H, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe P, Deniz Y. Improvement in patient-reported "taste" and association with smell in dupilumab-treated patients with severe chronic rhinosinusitis with nasal polyps from the SINUS-24 and SINUS-52 trials. Clin Exp Allergy. 2022 Sep;52(9):1105-1109. doi: 10.1111/cea.14194. Epub 2022 Jul 12. No abstract available.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wiley

ReferenceCitation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

oa_host_type: publisher

ReferenceCitation: Bachert C, Peters AT, Heffler E, Han JK, Olze H, Pfaar O, Chuang CC, Rout R, Attre R, Goga L, Jacob-Nara JA, Rowe PJ, Deniz Y, Chen Z, Kamat S, Siddiqui S. Responder analysis to demonstrate the effect of targeting type 2 inflammatory mechanisms with dupilumab across objective and patient-reported endpoints for patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 and SINUS-52 studies. Clin Exp Allergy. 2022 Feb;52(2):244-249. doi: 10.1111/cea.14051. No abstract available.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Lee SE, Hopkins C, Mullol J, Msihid J, Guillemin I, Amin N, Mannent LP, Li Y, Siddiqui S, Chuang CC, Kamat S, Khan AH. Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies. Allergy. 2022 Jul;77(7):2211-2221. doi: 10.1111/all.15222. Epub 2022 Feb 1.

oa_host_type: repository

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

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

unpaywall_oa_status: green

ReferenceCitation: Bachert C, Corren J, Lee SE, Zhang H, Harel S, Cunoosamy D, Khan AH, Jacob-Nara JA, Siddiqui S, Nash S, Rowe PJ, Deniz Y. Dupilumab efficacy and biomarkers in chronic rhinosinusitis with nasal polyps: Association between dupilumab treatment effect on nasal polyp score and biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps in the phase 3 SINUS-24 and SINUS-52 trials. Int Forum Allergy Rhinol. 2022 Sep;12(9):1191-1195. doi: 10.1002/alr.22964. Epub 2022 Jan 31. No abstract available.

ReferenceCitation: Hellings PW, Peters AT, Chaker AM, Heffler E, Zhang H, Praestgaard A, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe PJ, Deniz Y. Rapid and sustained effects of dupilumab in severe chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2022 Jul;12(7):958-962. doi: 10.1002/alr.22944. Epub 2022 Jan 23. No abstract available.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be

repositories_concat: LIRIAS (KU Leuven);PubMed Central;archive.ugent.be

ReferenceCitation: Han JK, Bachert C, Lee SE, Hopkins C, Heffler E, Hellings PW, Peters AT, Kamat S, Whalley D, Qin S, Nelson L, Siddiqui S, Khan AH, Li Y, Mannent LP, Guillemin I, Chuang CC. Estimating Clinically Meaningful Change of Efficacy Outcomes in Inadequately Controlled Chronic Rhinosinusitis with Nasal Polyposis. Laryngoscope. 2022 Feb;132(2):265-271. doi: 10.1002/lary.29888. Epub 2021 Dec 1.

ReferenceCitation: Chuang CC, Guillemin I, Bachert C, Lee SE, Hellings PW, Fokkens WJ, Duverger N, Fan C, Daizadeh N, Amin N, Mannent LP, Khan AH, Kamat S. Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds. Laryngoscope. 2022 Feb;132(2):259-264. doi: 10.1002/lary.29911. Epub 2021 Nov 24.

ReferenceCitation: Mullol J, Laidlaw TM, Bachert C, Mannent LP, Canonica GW, Han JK, Maspero JF, Picado C, Daizadeh N, Ortiz B, Li Y, Ruddy M, Laws E, Amin N. Efficacy and safety of dupilumab in patients with uncontrolled severe chronic rhinosinusitis with nasal polyps and a clinical diagnosis of NSAID-ERD: Results from two randomized placebo-controlled phase 3 trials. Allergy. 2022 Apr;77(4):1231-1244. doi: 10.1111/all.15067. Epub 2021 Oct 1.

ReferenceCitation: Khan AH, Reaney M, Guillemin I, Nelson L, Qin S, Kamat S, Mannent L, Amin N, Whalley D, Hopkins C. Development of Sinonasal Outcome Test (SNOT-22) Domains in Chronic Rhinosinusitis With Nasal Polyps. Laryngoscope. 2022 May;132(5):933-941. doi: 10.1002/lary.29766. Epub 2021 Aug 26.

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of East Anglia - UEA Digital Repository

ReferenceCitation: Hopkins C, Wagenmann M, Bachert C, Desrosiers M, Han JK, Hellings PW, Lee SE, Msihid J, Radwan A, Rowe P, Amin N, Deniz Y, Ortiz B, Mannent LP, Rout R. Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2021 Jul;11(7):1087-1101. doi: 10.1002/alr.22780. Epub 2021 Feb 21.

ReferenceCitation: Peters AT, Han JK, Hellings P, Heffler E, Gevaert P, Bachert C, Xu Y, Chuang CC, Neupane B, Msihid J, Mannent LP, Guyot P, Kamat S. Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2461-2471.e5. doi: 10.1016/j.jaip.2021.01.031. Epub 2021 Feb 4.

ReferenceCitation: Laidlaw TM, Bachert C, Amin N, Desrosiers M, Hellings PW, Mullol J, Maspero JF, Gevaert P, Zhang M, Mao X, Khan AH, Kamat S, Patel N, Graham NMH, Ruddy M, Staudinger H, Mannent LP. Dupilumab improves upper and lower airway disease control in chronic rhinosinusitis with nasal polyps and asthma. Ann Allergy Asthma Immunol. 2021 May;126(5):584-592.e1. doi: 10.1016/j.anai.2021.01.012. Epub 2021 Jan 16.

ReferenceCitation: Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19. Erratum In: Lancet. 2019 Nov 2;394(10209):1618.

location_facility:
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title: A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Romania
Netherlands
United States
Czechia
Bulgaria
Ukraine
Russian Federation
France


acronym: TRIDENT

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

type: Other Identifier

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Japan
Belgium
United States
Korea, Republic of
Ukraine
Bulgaria
Canada
Russian Federation
France


title: An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures

summary: This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

ReferenceCitation: Trigg A, Brohan E, Cocks K, Jones A, Tahami Monfared AA, Chabot I, Meier G, Campbell R, Li H, Ngo LY. Health-related quality of life in pediatric patients with partial onset seizures or primary generalized tonic-clonic seizures receiving adjunctive perampanel. Epilepsy Behav. 2021 May;118:107938. doi: 10.1016/j.yebeh.2021.107938. Epub 2021 Apr 8.

ReferenceCitation: Fogarasi A, Flamini R, Milh M, Phillips S, Yoshitomi S, Patten A, Takase T, Laurenza A, Ngo LY. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia. 2020 Jan;61(1):125-137. doi: 10.1111/epi.16413. Epub 2020 Jan 7.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Eisai Inc.

location_country:
Italy
Poland
Hungary
Japan
Belgium
United States
Korea, Republic of
Latvia
Spain
Czechia
Canada
France

location_facility:
Facility #2
Eisai Trial Site #1
Facility #3
Facility #1


title: An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

acronym: Encore-MDS

summary: A Phase 1, an Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 (RVT-2001) for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

design_allocation: Non-Randomized

lead_sponsor: Hemavant Sciences GmbH

location_country:
Italy
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier Universitaire d'Angers (CHU d'Angers)

location_facility: Azienda Ospedaliera Universitaria di Bologna - Policlinico S. Orsola Malpighi

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: IRCCS Istituto Clinico Humanitas Cancer Center

location_facility: Daegu Catholic University Medical Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Policlinico Maggiore

location_facility: Hospital Universitario y Politécnico La Fe de Valencia

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Hospital Universitario Fundación Jiménez Díaz

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


title: A Double Blind Placebo Controlled Study to Evaluate the Effect of Bexagliflozin Tablets on Hemoglobin A1c in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment

summary: This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM, moderate renal impairment and inadequate glycemic control.

lead_sponsor: Theracos

location_country:
United States
Spain
Japan
France

location_facility:
Research site
Research Site


acronym: BEIJERINCK

lead_sponsor: Amgen

summary:
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM.

The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.

ReferenceType: background

ReferenceCitation: Boccara F, Kumar PN, Caramelli B, Calmy A, Lopez JAG, Bray S, Cyrille M, Rosenson RS; BEIJERINCK Investigators. Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study. J Am Coll Cardiol. 2020 May 26;75(20):2570-2584. doi: 10.1016/j.jacc.2020.03.025. Epub 2020 Mar 28. Erratum In: J Am Coll Cardiol. 2020 Aug 11;76(6):762-765.

ReferenceCitation: Boccara F, Kumar P, Caramelli B, Calmy A, Lopez JAG, Bray S, Cyrille M, Rosenson RS. Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics. Am Heart J. 2020 Feb;220:203-212. doi: 10.1016/j.ahj.2019.11.004. Epub 2019 Nov 12.

ReferenceCitation: Boccara F, Caramelli B, Calmy A, Kumar P, Lopez JAG, Bray S, Cyrille M, Rosenson RS; investigators of the BEIJERINCK study. Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period. AIDS. 2022 Apr 1;36(5):675-682. doi: 10.1097/QAD.0000000000003175.

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.

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

version: acceptedVersion

title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Italy
Poland
Portugal
United Kingdom
Romania
Australia
Brazil
Switzerland
Belgium
United States
Spain
Greece
South Africa
Canada
France


acronym: ASCLEPIOS II

lead_sponsor: Novartis Pharmaceuticals

summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

ReferenceCitation: Gartner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Haring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

repository_institution: California Digital Library - eScholarship

publisher_dissemination: SAGE Publications

ReferenceCitation: Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Haring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Croatia
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
India
Belgium
Peru
Italy
Norway
United Kingdom
Austria
Mexico
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


title: A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

summary: Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

ReferenceCitation: Elliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy. Circ Heart Fail. 2022 Jan;15(1):e008193. doi: 10.1161/CIRCHEARTFAILURE.120.008193. Epub 2021 Dec 20.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Damy T, Garcia-Pavia P, Hanna M, Judge DP, Merlini G, Gundapaneni B, Patterson TA, Riley S, Schwartz JH, Sultan MB, Witteles R. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021 Feb;23(2):277-285. doi: 10.1002/ejhf.2027. Epub 2020 Nov 12.

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

repositories_concat: PubMed Central;ddfv.ufv.es

ReferenceCitation: Li B, Alvir J, Stewart M. Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial. Cardiol Ther. 2020 Dec;9(2):535-540. doi: 10.1007/s40119-020-00179-2. Epub 2020 Jun 10.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

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.

lead_sponsor: Pfizer

location_country:
Germany
Italy
United Kingdom
Argentina
Hong Kong
Australia
Brazil
Japan
Netherlands
Belgium
Sweden
United States
Spain
Taiwan
Czechia
Canada
France

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Boston Medical Center Investigational Pharmacy

location_facility: University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center

location_facility: Cardiovascular Clinical Trials Unit (CCTU)

location_facility: Stanford University Hospital and Clinics

location_facility: University of Calgary/Foothills Medical Centre

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University of Utah, Division of Cardiovascular Medicine

location_facility: Michigan Medicine,University of Michigan

location_facility: Michigan Medicine - Department of Pharmacy Services - Research Pharmacy

location_facility: Stanford Hospital and Clinics Investigational Pharmacy

location_facility: Altman Clinical Translational Research Institute

location_facility: Montreal Heart Institute-Research Center

location_facility: Hospital Universitário Clementino Fraga Filho (UFRJ)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of California, San Diego Medical Center - Hillcrest

location_facility: Barts Health NHS Trust, St Bartholomew's Hospital

location_facility: University health network-Toronto General Hospital

location_facility: Institut klinicke a experimentalni mediciny

location_facility: University Hospital, University of Alabama at Birmingham

location_facility: UCSF Cardiovascular Care and Prevention Center

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Columbia University Medical Center- Clinical Cardiovascular Research Laboratory for the Elderly


lead_sponsor: Boehringer Ingelheim

summary: Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment delay or overtreatment. This study is conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of extracellular matrix turnover which have been shown recently to correlate with disease progression. This study further aims to confirm the association of biomarker course during the first three months of treatment and disease progression.

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Noth I, Cottin V, Chaudhuri N, Corte TJ, Johannson KA, Wijsenbeek M, Jouneau S, Michael A, Quaresma M, Rohr KB, Russell AM, Stowasser S, Maher TM; INMARK trial investigators. Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial. Eur Respir J. 2021 Jul 8;58(1):2001518. doi: 10.1183/13993003.01518-2020. Print 2021 Jul.

repository_institution: Imperial College London - Spiral

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Ulster University - Ulster University Research Portal

repository_normalized: Pure (Denmark)

repositories:
HAL
PubMed Central
Pure (Denmark)
spiral.imperial.ac.uk

publisher_dissemination: European Respiratory Society

ReferenceCitation: Maher TM, Stowasser S, Nishioka Y, White ES, Cottin V, Noth I, Selman M, Rohr KB, Michael A, Ittrich C, Diefenbach C, Jenkins RG; INMARK trial investigators. Biomarkers of extracellular matrix turnover in patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study): a randomised, placebo-controlled study. Lancet Respir Med. 2019 Sep;7(9):771-779. doi: 10.1016/S2213-2600(19)30255-3. Epub 2019 Jul 17.

repository_institution: University of Liège - Open Repository and Bibliography

version: submittedVersion

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Maher TM, Stowasser S, Nishioka Y, White ES, Cottin V, Noth I, Selman M, Blahova Z, Wachtlin D, Diefenbach C, Jenkins RG. Investigating the effects of nintedanib on biomarkers of extracellular matrix turnover in patients with IPF: design of the randomised placebo-controlled INMARK(R)trial. BMJ Open Respir Res. 2018 Aug 20;5(1):e000325. doi: 10.1136/bmjresp-2018-000325. eCollection 2018.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Non-pub.Health Care NZOZ Profilaktyka W. Pierzchala,Katowice

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: Pulmonology Institute of Veszprem County, Farkasgyepu

location_facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: University of Florida College of Medicine

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Seoul National University Bundang Hospital

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Our Doctor Clinical Trial Center, Department in Bydgoszcz

location_facility: Concord General Repatriation Hospital -Ambulatory Care Unit

location_facility: Practice of Internists "Nasz Lekarz", Torun

location_facility: BAZ County Central Hospital and University Teaching Hospital

location_facility: Centre Hospitalier Universitaire de Liège

title: A 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.

ipd_sharing_description:
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

location_country:
Finland
Germany
Poland
Hungary
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Czechia
France


title: An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

summary: The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

ReferenceCitation: Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Lithuania
Slovakia
Hungary
United States
Belgium
Malaysia
Estonia
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Sweden


acronym: Omaspect

lead_sponsor: Hoffmann-La Roche

summary: This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: UCSF Comprehensive Cancer Ctr; Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

location_facility: Retina & Vitreous Center of Southern Oregon

location_facility: Macular Treatment Centre; Royal Eye Hospital

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: FISABIO. Fundación Oftalmologica del Mediterraneo

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Hospital Perpetuo Socorro; Servicio de Oftalmología

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

location_facility: University of California, Davis, Eye Center

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

location_facility: University of Michigan, Kellogg Eye Center

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Inselspital Bern, Universitätsklinik für Augenheilkunde

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: Uni of Alabama At Birmingham Clinical Research Unit

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Southeastern Retina Associates Chattanooga

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Eye Surgeons of Richmond Inc. dba Virginia Eye Institute

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Instituto Clinico Quirurgico de Oftalmologia - ICQO

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: Centre Monticelli Paradis d Ophtalmologie

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Centre Odeon; Exploration Ophtalmologique

status: Terminated

title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study

location_country:
Germany
Poland
Australia
Turkey
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Spain

status_simplified: Unknown


acronym: EXCEED 1

intervention_type: Biological

summary: This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

ReferenceCitation: McInnes IB, Behrens F, Mease PJ, Kavanaugh A, Ritchlin C, Nash P, Masmitja JG, Goupille P, Korotaeva T, Gottlieb AB, Martin R, Ding K, Pellet P, Mpofu S, Pricop L; EXCEED Study Group. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020 May 9;395(10235):1496-1505. doi: 10.1016/S0140-6736(20)30564-X. Erratum In: Lancet. 2020 May 30;395(10238):1694.

title: A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Iceland
India
Estonia
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Israel


title: A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

acronym: BeyoND

summary: This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease (PD).

ReferenceCitation: Poewe W, Stocchi F, Arkadir D, Ebersbach G, Ellenbogen AL, Giladi N, Isaacson SH, Kieburtz K, LeWitt P, Olanow CW, Simuni T, Thomas A, Zlotogorski A, Adar L, Case R, Oren S, Fuchs Orenbach S, Rosenfeld O, Sasson N, Yardeni T, Espay AJ; BeyoND study group. Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study. Mov Disord. 2021 Nov;36(11):2687-2692. doi: 10.1002/mds.28758. Epub 2021 Sep 8.

lead_sponsor: NeuroDerm Ltd.

location_country:
Germany
Italy
Poland
Israel
Austria
United States
Spain
Czechia
France

location_facility: Parkinsons Disease Treatment Center of Southwest Florida

location_facility: University of Florida Health at Jacksonville

location_facility: USF Health Parkinson's Disease and Movement Disorders

location_facility: Parkinson's Disease and Movement Disorder Center of Boca Raton

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Hadassah Medical Center, Ein-Kerem Campus

location_facility: Indywidualna Praktyka Lekarska prof. dr hab

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Rocky Mountain Movement Disorders Center


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

summary:
Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions.

The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

ReferenceCitation: Atkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2023 Jan;40(1):252-264. doi: 10.1007/s12325-022-02336-6. Epub 2022 Oct 27.

ReferenceCitation: Mease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Nov;38(11):1909-1922. doi: 10.1080/03007995.2022.2113689. Epub 2022 Aug 28.

publisher_dissemination: Informa

ReferenceCitation: Schnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.

ReferenceCitation: Conaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.

evidence: open (via free pdf)

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Conaghan PG, Abraham L, Viktrup L, Cislo P. Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 1;23(1):106. doi: 10.1186/s12891-022-05029-x.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Berenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Berenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.

ReferenceCitation: Berenbaum F, Langford R, Perrot S, Miki K, Blanco FJ, Yamabe T, Isogawa N, Junor R, Carey W, Viktrup L, West CR, Brown MT, Verburg KM. Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained? Eur J Pain. 2021 Aug;25(7):1525-1539. doi: 10.1002/ejp.1764. Epub 2021 May 3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Berenbaum F, Blanco FJ, Guermazi A, Miki K, Yamabe T, Viktrup L, Junor R, Carey W, Brown MT, West CR, Verburg KM. Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period. Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296. Epub 2020 Mar 31.

location_country:
Finland
Germany
Italy
Poland
Portugal
Slovakia
Hungary
United Kingdom
Romania
Japan
Sweden
Austria
Spain
Bulgaria
France

location_facility: Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -

location_facility: Centrum Terapii Wspolczesnej J.M Jasnorzewska

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,

location_facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica

location_facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska

location_facility: U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica

location_facility: Hospital General Universitario de Guadalajara

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

location_facility: Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital

location_facility: Corporació Sanitaria Parc Taulí de Sabadell

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: CTC (Clinical Trial Center), Sahlgrenska University Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: National Hospital Organization Utsunomiya national Hospital

location_facility: Complejo Hospital Universitario A Coruna (CHUAC)

location_facility: Hospital Regional Universitario de Malaga

location_facility: Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Multiprofile Hospital for Active Treatment-Silistra AD

location_facility: Sonodakai Joint Replacement Center Hospital

location_facility: Hospital Universitario La Paz Servicio de Farmacia

location_facility: Multiprofile hospital for active treatment - "Lyulin" EAD

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil

location_facility: Unite Clinique Therapeutique des Maladies Osteoarticulaires

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz

location_facility: Diagnostic Consultative Center XIV- Sofia EOOD

location_facility: AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Avdelningen for kliniska provningar, S-huset

location_facility: Rheumazentrum Prof. Dr. med Gunther Neeck

location_facility: Multiprofile Hospital for active treatment "SVETA PETKA" AD

location_facility: NMTH 'Tsar Boris III". Clinic of Internal Diseases

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Health Centre, Bradford on Avon & Melksham Health Partnership

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Clinical Trials, Bradford on Avon Health Centre

location_facility: Azienda Ospedaliero-Universitaria E Policlinico Umberto I

location_facility: NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik

location_facility: Hospital Universitario La Princesa Farmacia - Ensayos Clinicos

location_facility: Farmacia AOUC Settore Sperimentazione Farmaci


acronym: SELECT-BEYOND

lead_sponsor: AbbVie

summary:
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

ReferenceCitation: Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18.

ReferenceCitation: Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.

ReferenceCitation: Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.

ReferenceCitation: Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83.

publisher_dissemination: British Medical Journal

ReferenceCitation: Strand V, Schiff M, Tundia N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.

location_facility: Healthcare Research Consultant /ID# 142815

location_facility: East Tallinn Central Hospital /ID# 142543

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 144700

location_facility: Pioneer Research Solutions, Inc. /ID# 151346

location_facility: Dartmouth-Hitchcock Medical Center /ID# 145958

location_facility: Paijat-Hame Central Hospital /ID# 149185

location_facility: Medizinische Universität Wien /ID# 142424

location_facility: Deerbrook Medical Associates /ID# 151712

location_facility: Rheumatology Clinic of Houston /ID# 150915

location_facility: Clinical Investigation Special /ID# 149270

location_facility: Hacettepe University Medical Faculty /ID# 142729

location_facility: Centre Hospitalier Jean Rougie /ID# 142556

location_facility: Bekes Megyei Pandy Kalman Korh /ID# 142588

location_facility: Arthritis Clinic of Central TX /ID# 148346

location_facility: Arthritis & Osteo Ctr of S. TX /ID# 142773

location_facility: Hopital Universitaire Purpan /ID# 144697

location_facility: The Queen Elizabeth Hospital /ID# 142419

location_facility: Inland Rheum Clin Trials Inc. /ID# 142787

location_facility: Schoen Klinikum Hamburg Eilbek /ID# 142566

location_facility: Trinity Health Med Arts Clinic /ID# 142754

location_facility: Wilhelminenspital der Stadt Wien /ID# 142422

location_facility: Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745

location_facility: St Vincent's University Hosp /ID# 142593

location_facility: Centrum Medyczne Pratia Gdynia /ID# 142666

location_facility: Orebro Universitetssjukhuset /ID# 142718

location_facility: Joint & Muscle Research Instit /ID# 142797

location_facility: West Tennessee Research Inst /ID# 142739

location_facility: General Hospital of Athens Laiko /ID# 142579

location_facility: Hospital Clin Univ San Carlos /ID# 142711

location_facility: Rheumatology Ctr of San Diego /ID# 153576

location_facility: East Penn Rheumatology Assoc /ID# 142790

location_facility: Comple Hosp Univ de A Coruna /ID# 142708

location_facility: Centro Hospitalar De Vila Nova /ID# 142670

location_facility: P. Stradins Clinical Univ Hosp /ID# 142623

location_facility: New England Research Associates, LLC /ID# 142763

location_facility: Mid Essex Hospitals NHS Trust /ID# 148992

location_facility: Diagnostic Group Integrated He /ID# 148340

location_facility: University of California, Los Angeles /ID# 148348

location_facility: Universitaetsklinik fuer Inner /ID# 142423

location_facility: Centrum Medyczne AMED Warszawa Targowek /ID# 142663

location_facility: Trinity Universal Research Association /ID# 149278

location_facility: Arizona Research Center, Inc. /ID# 142741

location_facility: AZ Arthritis & Rheum Research /ID# 156090

location_facility: St. Luke's Clinic - Rheumatolo /ID# 150923

location_facility: AZ Arthritis and Rheum Researc /ID# 148592

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 142668

location_facility: HFR Fribourg - Hopital Canton /ID# 142723

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587

location_facility: Rheumatic Disease Clin Res Ctr /ID# 150914

location_facility: St. Joseph Heritage Healthcare /ID# 149273

location_facility: Vanguard Medical Research, LLC /ID# 153123

location_facility: AZ Arthritis and Rheum Researc /ID# 142816

location_facility: Clinical Pharmacology Study Gr /ID# 142744

location_facility: Vital Medical Center Orvosi es /ID# 142586

location_facility: Narodny ustav reumatickych chorob Piestany /ID# 142691

location_facility: Ankara Ataturk Training & Res /ID# 142727

location_facility: Medallion Clinical Research Institute, LLC /ID# 142740

location_facility: Revmatologie MUDr. Klara Sirova /ID# 142536

location_facility: Pacific Arthritis Ctr Med Grp /ID# 142783

location_facility: Arthritis Research of Florida /ID# 142811

location_facility: Houston Institute for Clin Res /ID# 142768

location_facility: Arthritis & Osteo Medical Ctr /ID# 142770

location_facility: Timaru Medical Specialists Ltd /ID# 142657

location_facility: Arth and Osteo Clin Brazo Valley /ID# 148343

location_facility: Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 142559

location_facility: Centrum Medyczne Pratia Warszawa /ID# 142667

location_facility: Arthritis & Osteoporosis Assoc /ID# 147567

location_facility: Coastal Carolina Health Care /ID# 148351

location_facility: H. Un. Marques de Valdecilla /ID# 142706

location_facility: Clinical Research Ctr Reading /ID# 151714

location_facility: Arthritis Care and Diagnostic /ID# 151344

location_facility: Revita Reumatologiai Rendelo /ID# 142590

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 142793

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 142597

location_facility: Cliniques Universitaires Saint Luc /ID# 142426

location_facility: Arthritis & Osteoporosis Clinic /ID# 142760

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 142820

location_facility: AZ Arthritis and Rheum Assoc /ID# 148593

location_facility: Western Washington Arthritis C /ID# 142776

location_facility: Hanyang University Seoul Hospi /ID# 150883

location_facility: North Shore University Hospital /ID# 142772

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665

location_facility: Family Outpatient clinic#4,LLC /ID# 150910

location_facility: Jefrey D. Lieberman, MD, P.C. /ID# 151713

location_facility: St. Anthony Comprehsve Res Ins /ID# 148349

location_facility: Ondokuz mayis University Facul /ID# 142728

location_facility: The Vancouver Clinic, INC. PS /ID# 147946

location_facility: Hospital Universitario La Fe /ID# 142716

location_facility: North Mississippi Med Clinics /ID# 142781

location_facility: Seoul National University Hospital /ID# 142622

location_facility: Stanford University School of Med /ID# 142761

location_facility: CHR Orleans - Hopital de la Source /ID# 142557

location_facility: The Center for Rheumatology & /ID# 142742

location_facility: TriWest Research Associates- La Mesa /ID# 142792

location_facility: Rheum Assoc of North Alabama /ID# 145959

location_facility: AZ Arthritis and Rheum Researc /ID# 146075

location_facility: LMU Klinikum der Universität München /ID# 142564

location_facility: Lovelace Scientific Resources /ID# 142779

location_facility: Rheuma Zentrum Favoriten GmbH /ID# 142421

title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Belgium
Estonia
Puerto Rico
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: A Phase 3, Prospective, Randomized, Double-blind, Multi-center Study of the Efficacy and Safety of Lanreotide Autogel®/Depot 120 mg Plus BSC vs. Placebo Plus BSC for Tumour Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumours

acronym: SPINET

summary:
This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs.

This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period.

The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours.

Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5.

The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.

lead_sponsor: Ipsen

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Netherlands
Austria
United States
Spain
Canada
France

location_facility: Szpital Kliniczny im. H. Święcickiego U.M.

location_facility: Institut du Cancer de Montpellier (ICM) Val d'Aurelle

location_facility: Zakladu Medycyny Nuklearne i Endokrynologii Onkologicznej

location_facility: Centre René Gauducheau ICO institut de Cancerologie de l'Ouest

location_facility: Johann Wolfgang Goethe-Universitätsklinikum Frankfurt

location_facility: Insituti Scientifico Romagnolo per lo Studio e la cura dei Tumori (IRST)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Azienda Ospedaliera Universitaria di Perugia Santa Maria della Misericordia

location_facility: AKH und Med. University Vienna Allg Krankenhaus Wien

location_facility: University Center of Ophtalmology & Oncology


title: Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

ReferenceCitation: Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.

lead_sponsor: Akebia Therapeutics

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
Serbia
France
Colombia
Slovakia
Hungary
United States
Ukraine
Romania
Malaysia
Puerto Rico
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility:
Research Site #1
Research Site
Research Site #2
Research Site #3


title: A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy

summary:
The purpose of this study are

to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and,
to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.

ReferenceCitation: DiNardo CD, Schuh AC, Stein EM, Montesinos P, Wei AH, de Botton S, Zeidan AM, Fathi AT, Kantarjian HM, Bennett JM, Frattini MG, Martin-Regueira P, Lersch F, Gong J, Hasan M, Vyas P, Dohner H. Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial. Lancet Oncol. 2021 Nov;22(11):1597-1608. doi: 10.1016/S1470-2045(21)00494-0. Epub 2021 Oct 18.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: DiNardo CD, Stein AS, Stein EM, Fathi AT, Frankfurt O, Schuh AC, Dohner H, Martinelli G, Patel PA, Raffoux E, Tan P, Zeidan AM, de Botton S, Kantarjian HM, Stone RM, Frattini MG, Lersch F, Gong J, Gianolio DA, Zhang V, Franovic A, Fan B, Goldwasser M, Daigle S, Choe S, Wu B, Winkler T, Vyas P. Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia. J Clin Oncol. 2021 Jan 1;39(1):57-65. doi: 10.1200/JCO.20.01632. Epub 2020 Oct 29. Erratum In: J Clin Oncol. 2021 Feb 1;39(4):341.

repositories_concat: PubMed Central;ora.ox.ac.uk

lead_sponsor: Celgene

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Canada
France

location_facility:
Local Institution - 204
Local Institution - 430
Local Institution - 107
Local Institution - 106
Local Institution - 105
Local Institution - 125
Local Institution - 110
Local Institution - 230
Local Institution - 227
Local Institution - 351
Local Institution - 253
Local Institution - 381
Local Institution - 377
Local Institution - 108
Local Institution - 250
Local Institution - 102
Local Institution - 376
Local Institution - 375
Local Institution - 205
Local Institution - 251
Local Institution - 252
Local Institution - 327
Local Institution - 428
Local Institution - 103
Local Institution - 202
Local Institution - 902
Local Institution - 175
Local Institution - 380
Local Institution - 200
Local Institution - 255
Local Institution - 401
Local Institution - 277
Local Institution - 427
Local Institution - 256
Local Institution - 379
Local Institution - 201
Local Institution - 378
Local Institution - 206
Local Institution - 403
Local Institution - 178
Local Institution - 203
Local Institution - 350
Local Institution - 254
Local Institution - 177
Beth Israel Deaconess Medical Center


title: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease

acronym: PERSIST-AVR

summary:
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study.

The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

ReferenceCitation: Lorusso R, Folliguet T, Shrestha M, Meuris B, Kappetein AP, Roselli E, Klersy C, Nozza M, Verhees L, Larracas C, Goisis G, Fischlein T. Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design. Thorac Cardiovasc Surg. 2020 Mar;68(2):114-123. doi: 10.1055/s-0038-1675847. Epub 2018 Nov 29.

ReferenceCitation: Fischlein T, Folliguet T, Meuris B, Shrestha ML, Roselli EE, McGlothlin A, Kappert U, Pfeiffer S, Corbi P, Lorusso R; Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators. Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis. J Thorac Cardiovasc Surg. 2021 Mar;161(3):920-932. doi: 10.1016/j.jtcvs.2020.11.162. Epub 2020 Dec 14.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Lorusso R, Ravaux JM, Pollari F, Folliguet TA, Kappert U, Meuris B, Shrestha ML, Roselli EE, Bonaros N, Fabre O, Corbi P, Troise G, Andreas M, Pinaud F, Pfeiffer S, Kueri S, Tan E, Voisine P, Girdauskas E, Rega F, Garcia-Puente J, Fischlein T; on behalf the PERSIST-AVR Investigators. Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial. Eur J Cardiothorac Surg. 2022 Sep 2;62(4):ezac164. doi: 10.1093/ejcts/ezac164.

repository_institution: KU Leuven - Lirias

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: Oxford University Press

ReferenceCitation: Lorusso R, Jiritano F, Roselli E, Shrestha M, Folliguet T, Meuris B, Pollari F, Fischlein T; PERSIST-AVR Investigators. Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial. Eur J Cardiothorac Surg. 2021 Dec 1;60(6):1359-1365. doi: 10.1093/ejcts/ezab175.

lead_sponsor: Corcym S.r.l

location_country:
Germany
Italy
Israel
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Chile
Canada
France

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Hospital University Germans Trias I Pujol

location_facility: Hospital Clinico Universitario Virgen De La Arrixaca

location_facility: Houston Methodist Research Institute, Houston Methodist Hospital

location_facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

location_facility: lstituto Clinico Sant'Ambrogio e San Siro

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Heart and Vascular Institute, Cleveland Clinic

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

location_facility: Complejo Hospitalario Universitario De A Coruña

intervention_type: Device