title: Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache

acronym: ALLEVIATE

summary: The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
Germany
Japan
Czechia
France
Portugal
Denmark
United States
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Spain
Greece
Georgia
Russian Federation
Sweden

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

location_facility: Northern Care Alliance NHS Foundation Trust

location_facility: Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center

location_facility: Eginition University - General Hospital of Athens

location_facility: Thomas Jefferson University Hospital - Center City Campus

location_facility: First Moscow State Medical University named after I.M. Sechenov

location_facility: The Ohio State University Wexner Medical Center

location_facility: General Hospital of Patras Agios Andreas

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Euromedica General Clinic - Thessaloniki

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

location_facility: Centro Hospitalar Universitario Lisboa Norte, E.P.E - Hospital De Santa Maria

location_facility: Hospitalsenhed Midt og Regionshospitalet Viborg

location_facility: Azienda Ospedaliero - Universitaria di Modena

location_facility: Froedtert and Medical College of Wisconsin

location_facility: Praxis für Neurologie, Psychosomatik, Nervenheilkunde, Psychotherapie und Spezielle Schmerztherapie

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

location_facility: Simon Khechinashvili University Hospital

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Cleveland Clinic - Neurological Institute

location_facility: Zuyderland Medisch Centrum Sittard-Geleen

location_facility: Archangel Saint Michael Multiprofile Clinical Hospital

location_facility: Universitatsklinikum Carl Gustav Carus Dresden

location_facility: St. Olavs Hospital - Universitetssykehuset I Trondheim

location_facility: Tampereen Yliopistollinen Sairaala (TAYS)

location_facility: New England Institute for Neurology and Headache

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Perm State Medical University named after E. A. Wagner of the Ministry of Healthcare of the Russi...

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: LLC Scientific and Practical Medical Center Innovation and Health

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Michigan Headache and Neurological Institute

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centre Hospitalier Chretien - Clinique MontLégia

location_facility: Hospital Clínico Universitario de Valladolid


study_start_date_type: Actual

acronym: SOLAR

intervention_type: Drug

lead_sponsor: Astellas Pharma Global Development, Inc.

summary:
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.

ReferenceType: derived

ReferenceCitation: Kelly RJ, Shepherd FA, Krivoshik A, Jie F, Horn L. A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Ann Oncol. 2019 Jul 1;30(7):1127-1133. doi: 10.1093/annonc/mdz128.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Vanderbilt University - Discover Archive

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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Site KR82001
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Site JP81021
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Site US10033
Site ES34005
Site KR82006
Site US10023
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status: Terminated

title: An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description:
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com

:

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Australia
Japan
Thailand
Chile
Canada
France
Portugal
Hungary
United States
Ukraine
Romania
Belgium
Malaysia
Peru
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Unknown


title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

summary:
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).

The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Optional Sub-Study:

The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.

The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

status: Completed

ReferenceCitation: Blauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2023 Jan;40(1):367-380. doi: 10.1007/s12325-022-02322-y. Epub 2022 Nov 1.

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

license: cc-by

license_normalized: cc-by

repository_institution: University of California - eScholarship University of California

repository_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: Springer-Nature

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

ReferenceCitation: Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaci D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.

ReferenceCitation: Beck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.

ReferenceCitation: Beck LA, Thaci D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.

repositories_institution:
Elsevier - Scopus
PubMed Central - Europe PMC

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Lithuania
Slovakia
Hungary
Denmark
United States
Romania
Belgium
China
Estonia
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Bulgaria
Russian Federation

location_facility:
Regeneron Study Site 1
Regeneron Study Site 3
Regeneron Study Site 4
Regeneron Study Site 6
Regeneron Study Site 2
Regeneron Study Site
Regeneron Study Site 7
Regeneron Study Site 8
Regeneron Study Site 5


title: An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.

This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Germany
Hungary
Australia
United States
Korea, Republic of
Spain
France

location_facility: Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Florida Cancer Specialists - 560 Jackson St, Suite 220

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Mark H Zangmeister Center - 3100 Plaza Properties Boulevard

location_facility: Florida Cancer Specialists - 3840 Broadway

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Regional Universitario de Malaga - Hospital Civil

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller


title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN

summary: The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Calliditas Therapeutics Suisse SA

location_country:
Germany
Italy
Poland
United Kingdom
United States
Spain
France

location_facility: Washington University School of Medicine Center for Advanced Medicine

location_facility: The Royal Marsden Hospital Head and Neck Unit

location_facility: Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario

location_facility: Centre de Lutte contre le Cancer - Centre Oscar Lambret

location_facility: Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie-Państwowy Instytut Badawczy O. w Gliwicach

location_facility: Institut Régional du Cancer de Montpellier

status_simplified: Ongoing


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

location_facility: The Institute for Liver Health-The Institute for Liver Health

location_facility: Research Foundation of SUNY - University of Buffalo

location_facility: Azienda Ospedaliera Universitaria Pisana-U.O. Epatologia

location_facility: Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna

location_facility: A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic

location_facility: University Diabetes & Endocrine Consultants

location_facility: NYU Langone Health-Department of Medicine

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

type: Other Identifier

location_country:
Germany
Italy
Israel
Argentina
United Kingdom
Japan
Brazil
Switzerland
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Puerto Rico
France


type: Registry Identifier

title: A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations

summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Hungary
Israel
Denmark
Australia
Japan
Netherlands
Singapore
Sweden
United Kingdom
United States
China
Spain
Turkey
Canada
Russian Federation
France

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)

location_facility: Hokkaido University Hospital ( Site 1800)

location_facility: Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)

location_facility: Massachusetts General Hospital ( Site 0111)

location_facility: West China Hospital of Sichuan University ( Site 1906)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 0901)

location_facility: Rigshospitalet-Department of Endocrinology ( Site 0303)

location_facility: Ege University Medicine of Faculty ( Site 0900)

location_facility: Universitaetsklinikum Freiburg ( Site 0504)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1308)

location_facility: National Cancer Center Hospital ( Site 1802)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)

location_facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site

location_facility: Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)

location_facility: Universitair Medisch Centrum Utrecht ( Site 1530)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)

location_facility: Skanes University Hospital Lund ( Site 1200)

location_facility: Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)

location_facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0804)

location_facility: Institut Paoli-Calmettes-Oncology ( Site 0406)

location_facility: Prince of Wales Hospital-Medical Oncology ( Site 1601)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)

location_facility: Vanderbilt University Medical Center ( Site 0107)

location_facility: Washington University-Internal Medicine/Oncology ( Site 0124)

location_facility: Kochi Medical School Hospital ( Site 1807)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1202)

location_facility: Sun Yat-sen University Cancer Center ( Site 1905)

location_facility: Odense Universitetshospital ( Site 0302)

location_facility: Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site

location_facility: The Royal Melbourne Hospital ( Site 1602)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 1304)

location_facility: Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0123)

location_facility: Ankara Bilkent Şehir Hastanesi. ( Site 0904)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0112)

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (

location_facility: CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)

location_facility: Yokohama City University Hospital-Department of Urology ( Site 1804)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 0705)

location_facility: Tokyo Women's Medical University Adachi Medical Center ( Site 1803)

location_facility: Peking University First Hospital-Urology ( Site 1900)

location_facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe

location_facility: Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

location_facility: Cedars-Sinai Medical Center ( Site 0110)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)

location_facility: MD Anderson Cancer Center-Oncology ( Site 1102)

location_facility: Hôpital Edouard Herriot-oncologie ( Site 0405)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1100)

location_facility: University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)

location_facility: National Cancer Centre Singapore ( Site 1700)

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)


acronym: Ph 1/2 Substudy of Oncological Treatment(s) in PD-1 naïve or PD-1 exposed participants with MBM

summary:
Substudy 02D is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued.

location_facility: Inova Schar Cancer Institute ( Site 4011)

location_facility: Hadassah Ein Karem Jerusalem ( Site 4702)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)

location_facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 4108)

location_facility: Providence Saint John's Health Center ( Site 4010)

location_facility: Istituto Europeo di Oncologia ( Site 4301)

location_facility: The Angeles Clinic and Research Institute ( Site 4009)

location_facility: Universitaetsspital Zuerich ( Site 4601)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

location_facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603)

location_facility: Rambam Health Care Campus-Oncology ( Site 4704)

location_facility: Hospital Universitario Ramón y Cajal ( Site 4802)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 4107)

location_facility: Centre Hospitalier Lyon Sud ( Site 4102)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)

location_facility: Melanoma Institute Australia ( Site 4402)

location_facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4865)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)

location_facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 4012)

location_facility: Rabin Medical Center-Oncology ( Site 4705)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 4377)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 4355)

title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

location_country:
France
Italy
Australia
Switzerland
United States
Spain
South Africa
Israel


acronym: MK-4482 Ph 2/3 Study in Hospitalized Adults with COVID-19

summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.

ReferenceType: result

ReferenceCitation: Arribas JR, Bhagani S, Lobo SM, Khaertynova I, Mateu L, Fishchuk R, Park WY, Hussein K, Kim SW, Ghosn J, Brown ML, Zhang Y, Gao W, Assaid C, Grobler JA, Strizki J, Vesnesky M, Paschke A, Butterton JR, De Anda C, for the MOVe-IN study group. Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19. NEJM Evid 2021; 1 (2) DOI: 10.1056/EVIDoa2100044. Published December 16, 2021. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2100044

doi: arribas

location_facility: Chungnam National University Hospital ( Site 2202)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0403)

location_facility: University of California Davis Health ( Site 1809)

location_facility: C.H.U. de Toulouse. Hopital de Purpan ( Site 0501)

location_facility: Centre Hospitalier de Tourcoing ( Site 0502)

location_facility: Volyn Regional Clinical Hospital ( Site 1613)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

location_facility: Hopital Bichat - Claude Bernard ( Site 0503)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)

location_facility: University of the Philippines-Philippine General Hospital ( Site 0900)

location_facility: University of New Mexico, Health Sciences Center ( Site 1806)

location_facility: Сommunal non-com. Institution Oleksandrivska clinical hospital Kyiv ( Site 1600)

location_facility: University of Mississippi Medical Center ( Site 1846)

location_facility: Complejo Hospitalario San Jose ( Site 0306)

location_facility: University of Nebraska Medical Center ( Site 1835)

location_facility: CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864)

location_facility: FSBI Central Hospital with Policlinics ( Site 1105)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1302)

location_facility: Hospital Universitari Vall d Hebron ( Site 1305)

location_facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

location_facility: Wits Baragwanath Clinical Trial Site ( Site 1204)

location_facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1001)

location_facility: Royal Free London NHS Foundation Trust ( Site 1700)

location_facility: Odesa City Clinical Infectious Hospital ( Site 1611)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

location_facility: Communal Non-Commercial Enterprise Central City Hospital ( Site 1615)

location_facility: Cedars-Sinai Medical Center ( Site 1822)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1004)

location_facility: Moscow Clinical Hospital #52 ( Site 1103)

location_facility: Clinica Universidad de los Andes ( Site 0301)

location_facility: Hospital Sotero del Rio [Santiago, Chile] ( Site 0304)

location_facility: Centrum Medyczne Pratia, Mazowiecki Szpital Specjalistyczny, Oddział Obserwacyjno - Zakaźny ( Site 1

location_facility: Krasnogorsk City Hospital Number 1 ( Site 1119)

location_facility: Servicio de Salud Sur Hospital Lucio Cordova ( Site 0305)

location_facility: Clinical Projects Research Centre ( Site 1205)

location_facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0104)

location_facility: Lung Center of the Philippines ( Site 0902)

location_facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

location_facility: Hospital Universitario San Ignacio ( Site 0401)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2103)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: Hospital Universitario La Paz ( Site 1300)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2205)

location_facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

location_facility: Groupe Hospitalier Pellegrin ( Site 0511)

location_facility: CNPE of Kharkiv RC Regional Clinical Infectious Diseases Hospital ( Site 1606)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

location_facility: Kaiser Foundation Hospital - South Bay ( Site 1832)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0100)

location_facility: North Manchester General Hospital ( Site 1701)

location_facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

location_facility: Centrum Medyczne w Lancucie Sp.zo.o. ( Site 1000)

location_facility: University Health Network - Toronto General Hospital ( Site 0201)

location_facility: Wellstar Kennestone Hospital ( Site 1801)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19

location_country:
Italy
Poland
Colombia
Russian Federation
Israel
United Kingdom
Brazil
Mexico
United States
Korea, Republic of
Spain
South Africa
Chile
Canada
Ukraine
Philippines
France


title: A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

summary: The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in participants with advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Dragonfly Therapeutics

location_country:
United States
Spain
Australia
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: HealthPartners Cancer Center at Regions Hospital

location_facility: Augusta University Georgia Cancer Center

location_facility: USOR - Virginia Cancer Specialists - Fairfax Office

location_facility: SCRI - Tennessee Oncology - Saint Thomas West Clinic


acronym: Ph 1/2 Substudy of Oncological Treatment(s) in PD-1 Refractory MEL

summary:
Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)

location_facility: Rambam Health Care Campus-Oncology ( Site 1704)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 1012)

location_facility: Tasman Oncology Research Pty Ltd ( Site 1403)

location_facility: Oregon Health & Science University ( Site 1013)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1355)

location_facility: Providence Saint John's Health Center ( Site 1010)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 1377)

location_facility: West Cancer Center - East Campus ( Site 1014)

location_facility: Centre Hospitalier Lyon Sud ( Site 1102)

location_facility: Melanoma Institute Australia ( Site 1402)

location_facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1603)

location_facility: Inova Schar Cancer Institute ( Site 1011)

location_facility: Istituto Europeo di Oncologia ( Site 1301)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 1107)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 1008)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399)

location_facility: Universitaetsspital Zuerich ( Site 1601)

location_facility: The Angeles Clinic and Research Institute ( Site 1009)

location_facility: University of Texas MD Anderson Cancer Center ( Site 1006)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1702)

location_facility: Calvary Mater Newcastle-Medical Oncology ( Site 1404)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1302)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602)

title: A Phase 1/2 Open-label Rolling-arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02A

location_country:
France
Italy
Australia
Switzerland
United States
Israel


acronym: DETERMINED 1

lead_sponsor: AbbVie

summary: The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 212563

location_facility: Hospital Santa Creu i Sant Pau /ID# 212009

location_facility: Hospital Universitario Virgen de las Nieves /ID# 212014

location_facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043

location_facility: Montefiore Medical Center - Moses Campus /ID# 211800

location_facility: Burke Pharmaceutical Research /ID# 211671

location_facility: The Royal Melbourne Hospital /ID# 212436

location_facility: Virginia Clinical Research, Inc. /ID# 215959

location_facility: Hospital General Universitario Gregorio Maranon /ID# 212011

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 212249

location_facility: Universitaetsklinikum Frankfurt /ID# 211913

location_facility: Integrative Skin Science and Research /ID# 212550

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 212564

location_facility: Nagoya City University Hospital /ID# 211155

location_facility: University of the Ryukyus Hospital /ID# 211373

location_facility: Modern Research Associates, PL /ID# 215202

location_facility: Penn State Hershey Medical Ctr /ID# 211659

location_facility: Bakersfield Derma & Skin Cance /ID# 211684

location_facility: CHU Toulouse - Hopital Larrey /ID# 213581

location_facility: Minnesota Clinical Study Center /ID# 211979

location_facility: Hospital General Universitario Alicante /ID# 212010

location_facility: California Dermatology Institute /ID# 211786

location_facility: HCL - Hopital Edouard Herriot /ID# 218408

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015

location_facility: Hospital Universitario Virgen de la Victoria /ID# 212013

location_facility: Wiseman Dermatology Research /ID# 212243

location_facility: Oregon Medical Res Center PC /ID# 211796

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912

location_facility: Staedtisches Klinikum Dessau /ID# 211914

location_facility: Beth Israel Deaconess Medical Center /ID# 211794

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

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:
Germany
Australia
Japan
Netherlands
United States
Spain
Canada
France

status_simplified: Completed


lead_sponsor: Advanced Accelerator Applications

summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.

ReferenceCitation: Strosberg JR, Caplin ME, Kunz PL, Ruszniewski PB, Bodei L, Hendifar A, Mittra E, Wolin EM, Yao JC, Pavel ME, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Mariani MF, Demange A, Mutevelic S, Krenning EP; NETTER-1 investigators. 177Lu-Dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1752-1763. doi: 10.1016/S1470-2045(21)00572-6. Epub 2021 Nov 15. Erratum In: Lancet Oncol. 2022 Feb;23(2):e59.

oa_host_type: closed

ReferenceCitation: Strosberg J, Kunz PL, Hendifar A, Yao J, Bushnell D, Kulke MH, Baum RP, Caplin M, Ruszniewski P, Delpassand E, Hobday T, Verslype C, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Paganelli G, Severi S, Morse M, Metz DC, Ansquer C, Courbon F, Al-Nahhas A, Baudin E, Giammarile F, Taieb D, Mittra E, Wolin E, O'Dorisio TM, Lebtahi R, Deroose CM, Grana CM, Bodei L, Oberg K, Polack BD, He B, Mariani MF, Gericke G, Santoro P, Erion JL, Ravasi L, Krenning E; NETTER-1 study group. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate: an analysis of the NETTER-1 study. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2372-2382. doi: 10.1007/s00259-020-04709-x. Epub 2020 Mar 2.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: Uppsala University - Uppsala University Publications

repository_institution: California Digital Library - eScholarship

repositories_concat: DiVA.org;LIRIAS (KU Leuven);PubMed Central;diposit.ub.edu;escholarship.org;ir.vanderbilt.edu;pure.eur.nl;repub.eur.nl

repositories_institution: Vanderbilt University - Discover Archive

ReferenceCitation: Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

oa_host_type: repository

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

oa_colors: green other

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Istituto Oncologico Romagnolo per lo Studio dei Tumori

location_facility: Excel Diagnostics and Nuclear Oncology Center

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Charité, Virchow-Klinikum, Gastroentrology, Hepatology & Endocrinology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Università "Sapienza" di Roma, Facoltà di Medicina e Psicologia, Ospedale S. Andrea-Roma

location_facility: Imperial College Healthcare Trust, Hammersmith Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Universitätsmedizin Mainz, Medizinische Klinik I Schwerpunkt Endokrinologie

location_facility: Digestive Oncology, Leuven Cancer Institute

location_facility: Cedars-Sinai Medical Center Samuel Oschin Cancer Center

location_facility: Azienda Ospedaliero - Universitaria Pisana (Presidio Ospedaliero S. Chiara)

title: A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

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:
Germany
Italy
Portugal
United Kingdom
Belgium
United States
Spain
France


title: A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)

summary: The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Lynde CW, Alam MS, Ohson K, Gagne-Henley A, Avadisian M, Vender RB. Enhanced Effectiveness of Adalimumab Compared to Topical/Traditional Systemic Agents in the Treatment of Moderate to Severe Plaque Psoriasis: Results from a Canadian Observational Epidemiologic Study (COMPLETE-PS). Dermatol Ther (Heidelb). 2022 Apr;12(4):921-931. doi: 10.1007/s13555-022-00703-3. Epub 2022 Mar 14.

ReferenceCitation: Menter A, Thaci D, Wu JJ, Abramovits W, Kerdel F, Arikan D, Guo D, Ganguli A, Bereswill M, Camez A, Valdecantos WC. Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry. Dermatol Ther (Heidelb). 2017 Sep;7(3):365-381. doi: 10.1007/s13555-017-0198-x. Epub 2017 Aug 16.

location_country:
Germany
Ireland
United Kingdom
Denmark
Sweden
Netherlands
Austria
United States
Spain
Greece
Czechia
Canada
Puerto Rico
France

location_facility: Dermatology Associates of Seattle /ID# 19802

location_facility: The Dermatology Inst of S. TX /ID# 38288

location_facility: Austin Dermatology Associates /ID# 38296

location_facility: Medical Dermatology Specialist /ID# 76113

location_facility: Dermatology Medical Group of Oxnard /ID# 17102

location_facility: Northwestern University Feinberg School of Medicine /ID# 28169

location_facility: NW GA Dermatology & Skin Cancer Specialists /ID# 17089

location_facility: Central Dermatology Center, PA /ID# 17070

location_facility: Shoreline Skin Specialists, SC /ID# 69771

location_facility: Fakultni nemocnice u sv. Anny v Brne /ID# 37062

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 17148

location_facility: Heights Dermatology & Aesthetic Center /ID# 28325

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 27934

location_facility: Dermatology Associates of Seattle /ID# 18328

location_facility: Duplicate_Hospital Errikos Ntynan /ID# 28272

location_facility: Hospital Universitario de la Princesa /ID# 18867

location_facility: Dermatology Associates of Indiana /ID# 24269

location_facility: Duplicate_Vseobecna fakultni nemoc Praze /ID# 27933

location_facility: Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 27923

location_facility: Fakultni nemocnice Hradec Kralove /ID# 40201

location_facility: Duplicate_Duplicate_Oosterschelde Ziekenhuis /ID# 20462

location_facility: Skin Physicians & Surgeons Med /ID# 40265

location_facility: Dermatology Associates of San Antonio /ID# 17150

location_facility: Dr. Reinaldo Rosario Med Offic /ID# 24328

location_facility: Dermatology Associates of the Palm Beaches /ID# 17137

location_facility: Northeast Alabama Dermatology /ID# 76193

location_facility: Wilmington Dermatology Center /ID# 69763

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 22846

location_facility: Dermatology and Skin Cancer Specialists, LLC /ID# 65884

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 27944

location_facility: Dermatology & Laser Center NW /ID# 18324

location_facility: Private Practice- Dr. Tory Sullivan /ID# 17126

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 27942

location_facility: Florida Academic Centers Research and Education /ID# 24273

location_facility: Universitaetsklinikum Muenster /ID# 37066

location_facility: Dartmouth-Hitchcock Medical Center /ID# 20502

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 24271

location_facility: Northwest Georgia Dermatology /ID# 28162

location_facility: The Dermatology Center PSC - New Albany /ID# 20501

location_facility: RI Dermatology & Cosmetic Ctr /ID# 40270

location_facility: Hospital Universitari Sagrat Cor - Grupo Quiron Salud /ID# 19767

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 17543

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 20723

location_facility: Tulsa Dermatology Clinic, Inc. /ID# 71675

location_facility: Northern Care Alliance NHS Group /ID# 40203

location_facility: Assoc. Derm & Skin Cancer Clin /ID# 24303

location_facility: Ft. Lauderdale Derm & Cosmetic /ID# 23071

location_facility: Dermatology Research Associates /ID# 17158

location_facility: Reflections Dermatology & Psoriasis canter /ID# 19781

location_facility: Advanced Dermatology & Cosmetic Care /ID# 20511

location_facility: Epiphany Dermatology of Kansas LLC /ID# 19764

location_facility: Belleville Dermatology Center /ID# 17067

location_facility: Dermatology Treatment and Research Center /ID# 17545

location_facility: Dr. Jensen Yeung Medicine Professional Corporation /ID# 28141

location_facility: Center for Dermatology Clinical Research /ID# 20722

location_facility: University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 24223

location_facility: Water's Edge Dermatology - Stuart /ID# 76114

location_facility: Skin and Laser Surgery Center /ID# 40182

location_facility: New York Presbyterian Hospital Weill Cornell Medical Center /ID# 24268

location_facility: The Dermatology Center, PSC - Bayside NY /ID# 28170

location_facility: General Hospital Andreas Syggros /ID# 25905

location_facility: Mercy Woodstock Medical Center /ID# 40186

location_facility: Hospital Universitario 12 de Octubre /ID# 18365

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 27954

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 27936

location_facility: Cardiff & Vale University Health Board /ID# 40204

location_facility: Tzaneio general hospital of Piraeus /ID# 28237

location_facility: CHU Reims - Hôpital Robert Debre /ID# 37064

location_facility: Gary L. Heller - Dermatology Research Cosmetic Center /ID# 17083

location_facility: St Vincent's University Hospital /ID# 43149

location_facility: Universitaetsklinikum Frankfurt /ID# 19801

location_facility: Texas Tech University Health Sciences Center - Lubbock /ID# 37050

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 28269

location_facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 20730

location_facility: Metro Hypertension and Kidney /ID# 40184

location_facility: Coastal Clinical Research Center of the Carolinas /ID# 18353

location_facility: Oregon Dermatology and Research Center /ID# 24327

location_facility: Medizinische Universitaet Wien /ID# 211020

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 40199

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 37067

location_facility: Panzer Dermatology & Cosmetic /ID# 17131

location_facility: General Hospital Andreas Syggros /ID# 22848

location_facility: Spencer Dermatology Associates /ID# 71678

location_facility: Camelback Dermatology & Skin Surgery /ID# 18901

location_facility: Great Plains Dermatology, P.A. /ID# 23079

location_facility: Solano Dermatology Associates /ID# 20727

location_facility: AP-HM - Hopital Sainte Marguerite /ID# 28270

location_facility: Universitaetsklinikum Leipzig /ID# 20604

location_facility: The Royal Free London NHS Foundation Trust /ID# 40205

location_facility: Rush University Medical Center /ID# 47604

location_facility: Alliance Dermatology and MOHs Center, PC /ID# 17087

location_facility: Central Florida Dermatology Associates /ID# 20508

location_facility: Fernandez-Obregon, Hoboken, NJ /ID# 23073

location_facility: Duplicate_Univ Hosp, Plzen, CZ /ID# 27924

location_facility: Medizinische Universitaet Graz /ID# 24263

location_facility: NHS Greater Glasgow and Clyde /ID# 27956

location_facility: Dermatologic Surgery Specialis /ID# 17149

location_facility: Iacobelli, Clinton Twnshp, MI /ID# 38290

location_facility: Brigham Dermatology Associates /ID# 28207

location_facility: Suncoast Dermatology and Skin Surgery Center /ID# 23067

location_facility: Total Skin and Beauty Derm Ctr /ID# 17156

location_facility: Kepler Universitaetsklinikum GmbH /ID# 27922

location_facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 18361

location_facility: Skin Cancer & Cosmetic Derm Ct /ID# 23313

location_facility: Tidewater Skin Care/Pathology /ID# 71674

location_facility: Arlington Research Center, Inc /ID# 23063

location_facility: Mountain State Clinical Research /ID# 28146

location_facility: CHRU Tours - Hopital Trousseau /ID# 28271

location_facility: Centre de Dermatologie Maizerets /ID# 20515

location_facility: Dermatology Associates of Coastal Carolina /ID# 76116

location_facility: Eastern Washington Dermatology /ID# 17542

location_facility: Allied Dermatology and Skin Surgery /ID# 28154

location_facility: Panzer Dermatology & Cosmetic /ID# 17146

location_facility: The Guenther Dermatology Research Centre /ID# 79196

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 17152

location_facility: Duplicate_Vseobecna fakultni nemoc Praze /ID# 25907

location_facility: Universitaetsklinik Heidelberg /ID# 20601

location_facility: PMG Research of Winston-Salem /ID# 17133

location_facility: Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 22844

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 40202

location_facility: McLain Medical Associates, PC /ID# 18351

location_facility: Academic Dermatology of Nevada /ID# 20513

location_facility: Loyola University Medical Ctr /ID# 23065

location_facility: Premiere Clinical Research,LLC /ID# 44719

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 37063

location_facility: Oregon Medical Research Center /ID# 28143

location_facility: CHRU de Besancon - Site Saint-Jacques /ID# 24202

location_facility: George Washington University Hospital /ID# 24270

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 22843

location_facility: Univ California, San Francisco /ID# 28267

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 19763

location_facility: General Hospital of Giannitsa /ID# 27951

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 28273

location_facility: Thessaloniki hospital for skin and venereal diseases- Ippokrateio Thessaloniki /ID# 37068

location_facility: Duplicate_University Hospital St. Polten /ID# 22842

location_facility: Pinnacle Dermatology - Grand Blanc /ID# 40196

location_facility: Medizinische Universitaet Wien /ID# 18364

location_facility: Radboud Universitair Medisch Centrum /ID# 24265

location_facility: The Indiana Clinical Trials Center /ID# 17153

location_facility: UMDNJ R. W. Johnson Med School /ID# 24326

location_facility: NewLab Clinical Research Inc. /ID# 18360

location_facility: Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 28232

location_facility: General Hospital Andreas Syggros /ID# 22847


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA

acronym: SELECT-GCA

summary: This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.

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, analyses plans, 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:
Germany
New Zealand
Australia
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Russian Federation
Israel

location_facility: Unidade Local de Saúde da Guarda, EPE /ID# 224878

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 171544

location_facility: Universitaetsklinikum Tuebingen /ID# 223854

location_facility: Medallion Clinical Research Institute, LLC /ID# 168666

location_facility: Clinical Research of West Florida, Inc /ID# 201901

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 224266

location_facility: Inselspital, Universitätsspital Bern /ID# 201364

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 208950

location_facility: CHRU Tours - Hopital Trousseau /ID# 245232

location_facility: Lovelace Scientific Resources /ID# 169041

location_facility: Universitair Medisch Centrum Groningen /ID# 201715

location_facility: Clinical Research of West Florida - Tampa /ID# 201899

location_facility: University of Alberta Hospital - Division of Hematology /ID# 208629

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208151

location_facility: University of Michigan Hospitals /ID# 168645

location_facility: Universitaetsklinikum Wuerzburg /ID# 213340

location_facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781

location_facility: General Hospital of Athens Ippokratio /ID# 202181

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 171543

location_facility: Karolinska University Hospital Solna /ID# 204945

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 171199

location_facility: Royal Devon University Healthcare NHS Foundation Trust /ID# 202834

location_facility: Azienda Sanitaria dell'Alto Adige/Ospedale di Bolzano /ID# 200081

location_facility: Szent Imre Egyetemi Oktatokorhaz /ID# 201838

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186

location_facility: Practicheskaya Medicina Clinic /ID# 224612

location_facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887

location_facility: Hospital Universitario Basurto /ID# 224730

location_facility: University Hospitals Dorset NHS Foundation Trust /ID# 202836

location_facility: The Chaim Sheba Medical Center /ID# 241041

location_facility: Institute of Arthritis Research /ID# 168490

location_facility: Radboud Universitair Medisch Centrum /ID# 212925

location_facility: Kemerovo State Medical University /ID# 203676

location_facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 224731

location_facility: Sahlgrenska University Hospital /ID# 171405

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 201526

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 203673

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 168667

location_facility: Arthritis Associates of Kingsport /ID# 212756

location_facility: Hospital Universitario La Paz /ID# 241848

location_facility: Piedmont Arthritis Clinic, PA /ID# 212431

location_facility: Liverpool University University Hospitals NHS Foundation Trust /ID# 240391

location_facility: University of Rochester Medical Center /ID# 213527

location_facility: Universitair Ziekenhuis Leuven /ID# 202779

location_facility: VA Long Beach Healthcare System /ID# 203833

location_facility: Rheumatology Associates PA - Portland /ID# 225011

location_facility: AA Medical Research Center - Grand Blanc /ID# 201854

location_facility: The Queen Elizabeth Hospital /ID# 201939

location_facility: HFR Fribourg - Hôpital cantonal /ID# 201114

location_facility: Centre de Recherche Musculo-Squelettique /ID# 201224

location_facility: The Lady Davis Carmel Medical Center /ID# 240731

location_facility: West Texas Clinical Research /ID# 204834

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 200079

location_facility: The Center for Rheumatology and Bone Research /ID# 168652

location_facility: Wayne State University Health Center /ID# 212755

location_facility: Hospital Clinic de Barcelona /ID# 201878

location_facility: Haukeland universitetssjukehus /ID# 201602

location_facility: Hospital Universitario Virgen de las Nieves /ID# 224726

location_facility: CHU Toulouse - Hopital Purpan /ID# 171547

location_facility: Hospital General Universitario Gregorio Maranon /ID# 201326

location_facility: University of Vermont Medical Center /ID# 211179

location_facility: CHU UCL Namur - site Godinne /ID# 224334

location_facility: Japanese Red Cross Kumamoto Hospital /ID# 203507

location_facility: Duplicate_Jichi Medical University Hosp /ID# 200169

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761

location_facility: Hospital Clinico Universitario San Carlos /ID# 204871

location_facility: Medizinische Hochschule Hannover /ID# 200632

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 213529

location_facility: HCL - Hopital de la Croix-Rousse /ID# 211184

location_facility: Timaru Medical Specialists Ltd /ID# 201943

location_facility: Torbay and South Devon Nhs Foundation Trust /Id# 224689

location_facility: Medizinische Universitaet Innsbruck /ID# 201786

location_facility: Hospital Universitario Canarias /ID# 224928

location_facility: Physician Research Collaboration, LLC /ID# 168610

location_facility: Arthritis and Rheumatology Institute, PLLC /ID# 214612

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 201604

location_facility: Duplicate_West Michigan Rheumatology /ID# 168647

location_facility: St. Marianna University Hospital /ID# 218692

location_facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702

location_facility: Rush University Medical Center /ID# 224581

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 201853

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018

location_facility: Precision Comprehensive Clinical Research Solutions /ID# 201798

location_facility: University Clinical Research Center /ID# 202504

location_facility: West Tennessee Research Institute /ID# 209256

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040

location_facility: Western Connecticut Health Network- Germantown Rd /ID# 205071

location_facility: Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 203530

location_facility: 424 General MILITARY Hospital /ID# 210973

location_facility: Hopital de la Cavale Blanche /ID# 171549

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 171200

location_facility: Duplicate_Vastmanlands Sjukhus /ID# 171429

location_facility: General Hospital of Athens Gennimatas /ID# 210129

location_facility: Rheum Assoc of North Alabama /ID# 168668

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082

location_facility: IRIS Research and Development, LLC /ID# 169406

location_facility: Cabinet Medical Dr. Avram S.R.L /ID# 224336

location_facility: St.Luke's International Hospital /ID# 200170

location_facility: Froedtert Memorial Lutheran Hospital /ID# 224557

location_facility: Portsmouth Hospitals University NHS Trust /ID# 225002

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454


title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

acronym: SELECT-COMPARE

summary: The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

ReferenceType: background

ReferenceCitation: Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 28.

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: Mysler E, Tanaka Y, Kavanaugh A, Aletaha D, Taylor PC, Song IH, Shaw T, Song Y, DeMasi R, Ali M, Fleischmann R. Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE. Rheumatology (Oxford). 2023 May 2;62(5):1804-1813. doi: 10.1093/rheumatology/keac477.

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

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

publisher_dissemination: Oxford University Press

ReferenceCitation: Peterfy CG, Strand V, Friedman A, Hall S, Mysler E, Durez P, Baraliakos X, Enejosa JV, Shaw T, Li Y, Chen S, Song IH. Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. Rheumatology (Oxford). 2022 Aug 3;61(8):3246-3256. doi: 10.1093/rheumatology/keab861.

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: Strand V, Tundia N, Bergman M, Ostor A, Durez P, Song IH, Enejosa J, Schlacher C, Song Y, Fleischmann R. Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. Rheumatology (Oxford). 2021 Dec 1;60(12):5583-5594. doi: 10.1093/rheumatology/keab158.

ReferenceCitation: Fleischmann RM, Blanco R, Hall S, Thomson GTD, Van den Bosch FE, Zerbini C, Bessette L, Enejosa J, Li Y, Song Y, DeMasi R, Song IH. Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis. Ann Rheum Dis. 2021 Apr;80(4):432-439. doi: 10.1136/annrheumdis-2020-218412. Epub 2020 Nov 4.

evidence: open (via page says license)

repository_institution: Ghent University - Ghent University Academic Bibliography

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.

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.

ReferenceCitation: Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Song IH. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019 Nov;78(11):1454-1462. doi: 10.1136/annrheumdis-2019-215764. Epub 2019 Jul 30.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Bosnia and Herzegovina
Kazakhstan
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Malaysia
Estonia
Puerto Rico
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: CHU de Rennes - Hospital Sud /ID# 151957

location_facility: Accurate Clinical Management /ID# 143089

location_facility: Centro Medico de Reumatologia /ID# 148402

location_facility: Cliniques Universitaires Saint Luc /ID# 142858

location_facility: Advanced Clin Res of Orlando /ID# 154617

location_facility: The Vancouver Clinic, INC. PS /ID# 143107

location_facility: University Clinical Centre of the Republic of Srpska /ID# 142863

location_facility: Hospital Universitario Reina S /ID# 153566

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071

location_facility: Kazan State Medical University /ID# 144871

location_facility: Centro Peninsular de Investiga /ID# 148159

location_facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 144709

location_facility: Innovative Clinical Research /ID# 145637

location_facility: Investigaciones Medicas SSMSO /ID# 151686

location_facility: Clinical Center of Vojvodina /ID# 143033

location_facility: Hanyang University Seoul Hospi /ID# 142979

location_facility: Taipei Veterans General Hosp /ID# 157940

location_facility: University of Arizona Cancer Center - North Campus /ID# 143114

location_facility: General Hospital of Athens Laiko /ID# 142934

location_facility: Ryazan State Medical Universit /ID# 143031

location_facility: Joint & Muscle Research Instit /ID# 143119

location_facility: First City Clinical Hospital /ID# 158011

location_facility: Clinical Research Ctr Reading /ID# 143133

location_facility: FL Med Ctr and Research, Inc. /ID# 143081

location_facility: Arthritis Research of Florida /ID# 143125

location_facility: St. Anthony Comprehsve Res Ins /ID# 143095

location_facility: AZ Arthritis and Rheum Researc /ID# 143080

location_facility: Hospital Raja Perempuan Zainab II /ID# 157862

location_facility: CHU Strasbourg Hautepierre Hos /ID# 144708

location_facility: ClinicMed Badurski i wspolnicy SJ /ID# 163300

location_facility: Quality Clinical Research Inc. /ID# 156394

location_facility: Riesgo de Fractura S.A - CAYRE /ID# 142896

location_facility: North Georgia Rheumatology Grp /ID# 147170

location_facility: Clinical Res of West FL, Inc. /ID# 143112

location_facility: Unidade Local De Saude Do Alto Minho /ID# 143009

location_facility: Lovelace Scientific Resources /ID# 143106

location_facility: Groupe de Recherche en Maladies Osseuses /ID# 142878

location_facility: Klinicki bolnicki centar Split /ID# 152530

location_facility: Albuquerque Clinical Trials, Inc /ID# 143083

location_facility: Diagnostic Consultative Center /ID# 142875

location_facility: Centro Integral de Reumatologi /ID# 142897

location_facility: Markusovszky Egyetemi Oktatókórház /ID# 145621

location_facility: Reumatologicka ambulancia, LER /ID# 143044

location_facility: Arthritis Care and Diagnostic /ID# 150677

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 142976

location_facility: A.O.U.I. di Verona Policlinico /ID# 142963

location_facility: China Medical University Hosp /ID# 143058

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960

location_facility: Revmatologie MUDr. Klara Sirov /ID# 142908

location_facility: Instituto Portugues De Reumatologia /ID# 148316

location_facility: Rheumatology Ctr of San Diego /ID# 153747

location_facility: Lviv Regional Clinical Hospita /ID# 154450

location_facility: Spitalul Clinic Dr. I. Cantacuzino /ID# 143017

location_facility: Solumed Sp. zoo Cent Medyczne /ID# 152783

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 143135

location_facility: Far Eastern Memorial Hospital /ID# 143061

location_facility: Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138

location_facility: Achieve Clinical Research, LLC /ID# 143136

location_facility: Arthritis & Osteo Ctr of S. TX /ID# 143103

location_facility: Arthritis & Osteoporosis Assoc /ID# 147364

location_facility: Arthritis and Rheum Clin N. CO /ID# 156094

location_facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 142966

location_facility: University Clinical Centre of the Republic of Srpska /ID# 142862

location_facility: Hevizgyogyfurdo es Szent Andra /ID# 142949

location_facility: Moscow State Univ Med and Dent /ID# 145623

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091

location_facility: SunValley Arthritis Center, Lt /ID# 143123

location_facility: Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063

location_facility: St Vincent's University Hosp /ID# 142957

location_facility: Kaohsiung Medical University /ID# 143059

location_facility: General Hospital of Athens Ippokratio /ID# 142935

location_facility: North Estonian Medical Centre /ID# 145454

location_facility: Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890

location_facility: Center of Clinical and Basic Research /ID# 142922

location_facility: H. Un. Marques de Valdecilla /ID# 143050

location_facility: Spitalul Clinic Dr. I. Cantacuzino /ID# 143012

location_facility: Seoul National University Hospital /ID# 142978

location_facility: Daugavpils Regional Hospital /ID# 142982

location_facility: Consultora Integral de Salud S /ID# 144856

location_facility: Chonnam National University Hospital /ID# 142975

location_facility: Rheumatology Clinic of Houston /ID# 150921

location_facility: Houston Institute for Clin Res /ID# 144879

location_facility: Centrum Medyczne AMED Warszawa Targowek /ID# 157621

location_facility: Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871

location_facility: Coastal Carolina Health Care /ID# 148359

location_facility: Karaganda State Medical Univ /ID# 153433

location_facility: Daegu Catholic University Med /ID# 142973

location_facility: JSC Nat Scientific Med Res Ctr /ID# 142971

location_facility: CCA Braga - Hospital de Braga /ID# 148317

location_facility: Centro Integral de Reumatologi /ID# 142845

location_facility: Clinical Research Solutions, LLC /ID# 154619

location_facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 142992

location_facility: Arthritis Clinical Research Tr /ID# 144874

location_facility: Healthcare Research Consultant /ID# 143129

location_facility: North Mississippi Med Clinics /ID# 145636

location_facility: AOU Citta della Salute Scienza /ID# 150070

location_facility: Linkou Chang Gung Memorial Ho /ID# 143057

location_facility: Lviv Municipal City Clinical /ID# 143068

location_facility: Klinicki bolnicki centar Rijeka /ID# 160232

location_facility: Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 145618

location_facility: Russian National Research Medi /ID# 143028

location_facility: NSC-Strazhesko Ist Cardiology /ID# 152030

location_facility: Vital Medical Center Orvosi es /ID# 145950

location_facility: Rheumatology and Immunotherapy Center /ID# 145646

location_facility: Tver Regional Clinical Hosp. /ID# 143026

location_facility: Orenburg State Medical Academy /ID# 143018

location_facility: Arizona Research Center, Inc. /ID# 144877

location_facility: Ctr for Arth and Rheum Disease /ID# 143113

location_facility: Centro Hospitalar De Vila Nova /ID# 143010

location_facility: Spitalul Clinic de Recuperare /ID# 144867

location_facility: AZ Arthritis and Rheum Assoc /ID# 143130

location_facility: East Tallinn Central Hospital /ID# 142923

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 142954

location_facility: Revita Reumatologiai Rendelo /ID# 142950

location_facility: The Center for Rheumatology & /ID# 151356

location_facility: Rheumatology Consultants, PLLC /ID# 153731

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 143055

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951

location_facility: Aprillus Asistencia e Investig /ID# 148406

location_facility: Arthritis Clinic of N. VA, P.C /ID# 143109

location_facility: Hospital de Clinicas de Porto Alegre /ID# 142870

location_facility: Mautalen Salud e Investigacion /ID# 142843

location_facility: Diagnostic Group Integrated He /ID# 148356

location_facility: Slovak research center Team Member, Thermium s.r.o. /ID# 147614

location_facility: Hosp Lithuanian Univ Health Sc /ID# 142986

location_facility: Centro Inter Estud Clin CIEC /ID# 144777

location_facility: C.V. Mehta MD, Med Corporation /ID# 143116

location_facility: Semey State Medical University /ID# 152659

location_facility: Consultorio Reumatologic Pampa /ID# 144853

location_facility: Reg. Clinical Hosptial Concepcion /ID# 151271

location_facility: AZ Arthritis & Rheum Research /ID# 156093

location_facility: Doctor's Hosp at Renaissance /ID# 154616

location_facility: Riga East Clinical Univ Hosp /ID# 142981

location_facility: CIP - Centro Internacional de Pesquisa /ID# 142872

location_facility: Republican clinical hospital n /ID# 145626

location_facility: Istanbul Universitesi Cerrahpa /ID# 156088

location_facility: Kyungpook National Univ Hosp /ID# 162073

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 151312

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 152871

location_facility: Ctr Int de Reum del Caribe SAS /ID# 142894

location_facility: University General Hospital Attikon /ID# 142933

location_facility: Synexus Helderberg Clinical Tr /ID# 148322

location_facility: Invest y Biomed de Chihuahua /ID# 142996

location_facility: NW State Med Univ NA Mechnikov /ID# 143022

location_facility: TriWest Research Associates- La Mesa /ID# 143115

location_facility: Warrington + Halton Hosp NHS /ID# 143075

location_facility: Clinical Center University of Sarajevo /ID# 142865

location_facility: Physician Res. Collaboration /ID# 143087

location_facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294

location_facility: SW FL Clin Res Ctr, Tampa, FL /ID# 143117

location_facility: Malopolskie Centrum Kliniczne /ID# 152782

location_facility: Perm Clinical Center of FMBA /ID# 145627

location_facility: Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169

location_facility: RM Pharma Specialists, S.A de C.V /ID# 142994

location_facility: Family Outpatient clinic#4,LLC /ID# 148319

location_facility: International Medical Research /ID# 143132

location_facility: Chungnam National University Hospital /ID# 142977

location_facility: Arthritis Center of North GA /ID# 155258

location_facility: Inst. Rheumatologic Strusberg /ID# 145601

location_facility: Clinical Pharmacology Study Gr /ID# 143082

location_facility: Winelands Medical Research Ctr /ID# 143048

location_facility: Chung Shan Medical University /ID# 143060

location_facility: Royal Prince Alfred Hospital /ID# 144857

location_facility: Pioneer Research Solutions, Inc. /ID# 145640

location_facility: AZ Arthritis and Rheum Researc /ID# 143121

location_facility: Revmatologicka a interni ambul /ID# 142907

location_facility: Arthritis Rheumatic Back Disorder /ID# 143102

location_facility: Hopital Universitaire Purpan /ID# 144707

location_facility: AZ Arthritis & Rheuma Research /ID# 143131

location_facility: Jakaranda Hosp, Emmed Research /ID# 143046

location_facility: Accurate Clinical Management /ID# 145644

location_facility: Ulyanovsk Regional Clin Hosp /ID# 143030

location_facility: Zaporizhzhia Regional Clinical /ID# 143069

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898

location_facility: Kiskunhalasi Semmelweis Korhaz /ID# 151944

location_facility: Odessa National Medical Univ /ID# 143072

location_facility: City Clinical Hospital Botkina /ID# 145628

location_facility: Timaru Medical Specialists Ltd /ID# 143000

location_facility: Nuselská poliklinika, Revmatologie /ID# 144862

location_facility: Med Versorgungszentrum AGILOME /ID# 154975

location_facility: LMU Klinikum der Universität München /ID# 142931

location_facility: Comple Hosp Univ de A Coruna /ID# 143051

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622

location_facility: Jakaranda Hosp, Emmed Research /ID# 145968


title: A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

ReferenceCitation: Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250.

publisher_dissemination: Wolters Kluwer Health

location_country:
Germany
Poland
Japan
Czechia
Canada
France
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Israel

location_facility: Wake Research Associates, LLC /ID# 122157

location_facility: Universitatsklinikum Frankfurt /ID# 170300

location_facility: Centrum Medyczne LukaMed Joanna Luka /ID# 170302

location_facility: The Oregon Clinic- Gastro West /ID# 135273

location_facility: University of Maryland Med Ctr /ID# 169734

location_facility: Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199

location_facility: Austin Center for Clinical Research /ID# 125396

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480

location_facility: Universitatsklinik Regensburg /ID# 201265

location_facility: Policlinico Univ Tor Vergata /ID# 129321

location_facility: Biopharma Informatic Research /ID# 171150

location_facility: Ospedali Riuniti Villa Sofia-C /ID# 129323

location_facility: Kitasato Univ Kitasato Inst Ho /ID# 127001

location_facility: Hospital Univ de la Princesa /ID# 135828

location_facility: The Royal Wolverhampton NHS Tr /ID# 127227

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138

location_facility: Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141

location_facility: Hospital Universitario La Paz /ID# 127223

location_facility: Winnipeg Regional Health Autho /ID# 125712

location_facility: Magyar Elhizastudomanyi KKft. /ID# 126589

location_facility: Gastroenterology Group Naples /ID# 127806

location_facility: Northwestern University Feinberg School of Medicine /ID# 122183

location_facility: Hospital Clinic de Barcelona /ID# 138147

location_facility: MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238

location_facility: Soroka University Medical Center /ID# 127213

location_facility: Hadassah University Hospital /ID# 127211

location_facility: Southampton General Hospital /ID# 127228

location_facility: Shiga University of Medical Science Hospital /ID# 127675

location_facility: C.M. Szpital Swietej Rodziny /ID# 127838

location_facility: Lviv City Clinical Hospital NO.4 /ID# 127232

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 134490

location_facility: Toho University Sakura Medical Center /ID# 124497

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322

location_facility: Policlinico Agostino Gemelli /ID# 127217

location_facility: Research Associates of South Florida,LLC /ID# 170309

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 125418

location_facility: Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002

location_facility: Hull and East Yorkshire Hospitals NHS Trust /ID# 127225

location_facility: Digestive Health Specialists of the Southeast /ID# 127844

location_facility: Ordination Hainburg an der Don /ID# 127185

location_facility: Gastroenterologicka Ambulancia /ID# 125632

location_facility: Ctr for Digest and Liver Dis /ID# 122182

location_facility: Dayton Gastroenterology, Inc. /ID# 127804

location_facility: Icahn School of Med Mt. Sinai /ID# 127047

location_facility: New River Valley Research Inst /ID# 127801

location_facility: Hepato-Gastroenterologie HK s.r.o. /ID# 127188

location_facility: Centrum Medyczne Pratia Gdynia /ID# 170301

location_facility: Medizinische Universitat Wien /ID# 127186

location_facility: Fukuoka University Chikushi Hospital /ID# 124155

location_facility: Texas Digestive Disease Consul /ID# 141677

location_facility: GI National Institute of Therapy named by L.T. Malaya /ID# 127231

location_facility: Hyogo College of Medicine College Hospital /Id# 127539

location_facility: Hidaka Clinic of Coloproctology /ID# 125477

location_facility: Kitasato University Hospital /ID# 137694

location_facility: Osaka Medical College Hospital /ID# 126451

location_facility: CHU NANCY - Hôpital Brabois Adultes /ID# 127196

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 127197

location_facility: Hospital General Universitario Gregorio Maranon /ID# 127224

location_facility: KO-Med Centra Kliniczne Pulawy /ID# 127219

location_facility: Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222

location_facility: Shafran Gastroenterology Ctr /ID# 122320

location_facility: Toronto Digestive Disease Asso /ID# 127075

location_facility: Erlanger Institute for Clinica /ID# 129009

location_facility: Tel Aviv Sourasky Medical Center /ID# 201365

location_facility: CHU de Grenoble - Albet Michal /ID# 127195

location_facility: Hospital General Universitario de Alicante /ID# 129261

location_facility: Rocky Mountain Clinical Resear /ID# 122180

location_facility: Hiroshima University Hospital /ID# 124496

location_facility: Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322

location_facility: Municipal Clinical Hospital #8 /ID# 127235

location_facility: Complejo Hospitalario Universitario de Ferrol /ID# 127840

location_facility: Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233

location_facility: Nagoya City University Hospital /ID# 124517

location_facility: Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324

location_facility: Norfolk and Norwich Univ Hosp /ID# 127139

location_facility: Froedtert & the Medical College of Wisconsin /ID# 122261

location_facility: Azienda Ospedaliera Spedali Civili /ID# 127236

location_facility: Centrum Diagnostyczno Lecznicze Barska /ID# 170304

location_facility: CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137

location_facility: H-T.Centrum Medyczne-Endoterapia /ID# 170305

location_facility: COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215

location_facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203

location_facility: Consultants for Clinical Res /ID# 122304

location_facility: Japanese Red Cross Kyoto Daiichi Hos /ID# 127540

location_facility: Texas Digestive Disease Consul /ID# 141678

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 127216

location_facility: Pannonia Maganorvosi Centrum Kft. /ID# 127207

location_facility: KH der Elisabethinen Linz GmbH /ID# 127184

location_facility: Universitatsklinikum Magdeburg /ID# 127200

location_facility: Medical Hospital of Tokyo Medical and Dental University /ID# 128315

location_facility: Asklepios Westklinikum Hamburg /ID# 127198

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209

location_facility: University of Michigan Hospitals /ID# 122240

location_facility: London Health Sciences Centre /ID# 127055

location_facility: Universitaetsklinik fuer Innere Medizin 1 /ID# 125944


title: A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) - STRIVE

acronym: STRIVE

summary: This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms.

location_country:
Germany
Italy
Portugal
Slovakia
Hungary
Norway
Denmark
Australia
Sweden
Netherlands
Austria
United States
Spain
Greece
Czechia
Puerto Rico
France

location_facility: Puerto Rico Children Hospital /ID# 47742

location_facility: The University of Chicago Medical Center /ID# 21981

location_facility: Children's Hosp P. A. Kyriakou /ID# 25448

location_facility: Medizinische Universitaet Graz /ID# 26126

location_facility: CHU Strasbourg - Hopital de Hautepierre /ID# 25450

location_facility: Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226

location_facility: Duplicate_Womens and Childrens Hospital /ID# 59182

location_facility: Children's Hospital Los Angeles /ID# 24386

location_facility: Duplicate_Arthritis Associates South FL /ID# 17001

location_facility: Hospital Universitario y Politecnico La Fe /ID# 37359

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 25447

location_facility: Center Rheumatology Child&Adol /ID# 39069

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 25449

location_facility: Children's National Medical Center /ID# 23506

location_facility: Hospital Universitario Severo Ochoa /ID# 41751

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 37360

location_facility: Nationwide Children's Hospital /ID# 21963

location_facility: Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223

location_facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 21023

location_facility: Duplicate_Universita di Napoli Federico II /ID# 39078

location_facility: Universitair Medisch Centrum Utrecht /ID# 48842

location_facility: Duplicate_CHU de Rennes - Hospital Sud /ID# 27123

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 25454

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 25452

location_facility: Narodny ustav reumatickych chorob /ID# 38102

location_facility: Asklepios Klinik Sankt Augustin /ID# 41622

location_facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 46402

location_facility: University of Rochester Medical Center /ID# 20967

location_facility: Arthritis Associates of Kingsport /ID# 44462

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 47401

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124

location_facility: CHRU Tours - Hopital Bretonneau /ID# 27126

location_facility: Methodist Medical Group Rheum /ID# 46343

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 39072

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623

location_facility: North Shore University Hospital /ID# 21022

location_facility: Universitaetsklinikum Tuebingen /ID# 39070

location_facility: Hospital Universitario Vall d'Hebron /ID# 37357

location_facility: Azienda Ospedaliero Universitaria Meyer /ID# 26123

location_facility: Legacy Emanuel Medical Center /ID# 14102

location_facility: Duplicate_Rigshospitalet, Finsen Centre /ID# 25444

location_facility: Hospital Universitario Ramon y Cajal /ID# 41624

location_facility: Catalina Pointe Clinical Research /ID# 40227

location_facility: Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 95863

location_facility: Duplicate_Universita di Catania /ID# 39075

location_facility: Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047

location_facility: Medizinische Universitaet Wien /ID# 26127

location_facility: Kepler Universitaetsklinikum GmbH /ID# 39068


title: Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study

summary: The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Bichat Claude Bernard

location_facility: Centre Hospitalier Universitaire Antoine Beclere

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier de Châlons-en-Champagne

location_facility: Centre Hospitalier Universitaire Lariboisiere

location_facility: Centre Hospitalier Universitaire d'Orléans

location_facility: Centre Hospitalier Mémorail France Etats Unis Saint Lo

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Centre Hospitalier Universitaire de Poitiers

lead_sponsor_type: academique