summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.

ReferenceCitation: Dorner T, Tanaka Y, Dow ER, Koch AE, Silk M, Ross Terres JA, Sims JT, Sun Z, de la Torre I, Petri M. Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 May 24;81(9):1267-72. doi: 10.1136/annrheumdis-2022-222335. Online ahead of print.

ReferenceCitation: Dorner T, van Vollenhoven RF, Doria A, Jia B, Ross Terres JA, Silk ME, de Bono S, Fischer P, Wallace DJ. Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Arthritis Res Ther. 2022 May 16;24(1):112. doi: 10.1186/s13075-022-02794-x.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

ReferenceCitation: Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dorner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1. Erratum In: Lancet. 2018 Aug 11;392(10146):476.

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

location_facility: Clinical Research Center of Reading, LLC

location_facility: Accent Clinical Research Professionals, LLC

location_facility: The Oklahoma Center For Arthritis Therapy

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: North Shore University Hospital at Great Neck

location_facility: Louisiana State University Health Sciences Center

location_facility: West Broward Rheumatology Associates, Inc

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

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

location_country:
Poland
Argentina
Romania
Japan
Austria
Mexico
United States
Korea, Republic of
Spain
Taiwan
Puerto Rico
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.

location_facility: Shanahan Rheumatology & Immunology, PLLC

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Great Western Hospitals NHS Foundation Trust.

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

status: Completed

title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Portugal
United Kingdom
United States
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase 3, Multicenter, Randomized, 48 Week, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate Efficacy and Safety of CER-001 on Vessel Wall Area in Patients With Genetically Defined Familial Primary Hypoalphalipoproteinemia

acronym: TANGO

summary: The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.

status: Terminated

ipd_sharing: Undecided

ipd_sharing_description: To be determined

lead_sponsor: Cerenis Therapeutics, SA

location_country:
France
Italy
Netherlands
Belgium
United States
Canada
Israel

status_simplified: Unknown


title: A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis

acronym: AURIEL-PsO

summary: The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

lead_sponsor: Fresenius Kabi SwissBioSim GmbH

sponsor_collaborators:
Fresenius Kabi SwissBioSim GmbH
Merck KGaA, Darmstadt, Germany

location_country:
Germany
Poland
Hungary
United Kingdom
Estonia
Mexico
United States
Czechia
Bulgaria
Canada
Russian Federation
France

location_facility: SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Unidad de Investigacion de las Enfermedades Reumaticas

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: Praxis fuer Dermatologie und Venerologie

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Dermatology Treatment and Research Center

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Ambrozia Gondozohaz Szolg. Nonprofit Kft.

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

location_facility: LLC "Alliance Biomedical - Russian Group"

location_facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

location_facility: San Luis Dermatology & Laser Clinic, Inc.

location_facility: Florida Academic Centers Research and Education

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain

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

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque

location_facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

location_facility: Dr Melinda Gooderham Medicine Professional Corporation

location_facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF


title: Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days

acronym: CLARINET FORTE

summary: This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.

lead_sponsor: Ipsen

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Denmark
Netherlands
Belgium
Spain
France

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 5

location_facility: Nationales Centrum für Tumorerkrankungen (NCT)

location_facility: Azienda Ospedaliera - Universitaria Careggi

location_facility: Università degli Studi "Federico II" di Napoli

location_facility: Fondacione IRCCS Istituto Nazionale Dei Tumori

location_facility: Hospital Universitario Central de Asturias

location_facility: The Christie Hospital NHS Foundation Trust


type: Other Identifier

title: A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

acronym: STARTRK-NG

summary: This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Desai AV, Robinson GW, Gauvain K, Basu EM, Macy ME, Maese L, Whipple NS, Sabnis AJ, Foster JH, Shusterman S, Yoon J, Weiss BD, Abdelbaki MS, Armstrong AE, Cash T, Pratilas CA, Corradini N, Marshall LV, Farid-Kapadia M, Chohan S, Devlin C, Meneses-Lorente G, Cardenas A, Hutchinson KE, Bergthold G, Caron H, Chow Maneval E, Gajjar A, Fox E. Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG). Neuro Oncol. 2022 Oct 3;24(10):1776-1789. doi: 10.1093/neuonc/noac087.

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: Washington University School of Medicine - Digital Commons@Becker

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: submittedVersion

repositories_concat: PubMed Central;digitalcommons.wustl.edu

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ReferenceCitation: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

oa_host_type: repository

version: acceptedVersion

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

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

repository_institution: University of California - eScholarship University of California

unpaywall_oa_status: green

publisher_dissemination: Elsevier

location_country:
Germany
Italy
United Kingdom
Hong Kong
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Morgan Stanley Children's Hospital; Herbert Irving Cancer Center

location_facility: Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

location_facility: Nationwide Children's Hospital; Dept. of Pulmonology

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: National Taiwan University Hospital; Department of Paediatrics

location_facility: Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology

location_facility: Children's National Medical Center; Department of Pediatrics

location_facility: Texas Children's Cancer and Hematology Center

location_facility: Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department

location_facility: A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM

location_facility: UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology

location_facility: University of Chicago; Comer Children's Hospital/Department of Pediatrics

location_facility: Children's Hospital Colorado; Center For Cancer/Blood Disorder

location_facility: Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder

location_facility: University of Minnesota Childrens' Hospital

location_facility: Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine

location_facility: Institut Gustave Roussy; Service de Pathologie Morphologique

location_facility: Memorial Sloan Kettering Cancer Center; Pediatrics

status_simplified: Ongoing


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

location_facility: Universitaetsklinik Fuer Innere Medizin 3

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Centrum Badan Klinicznych JCI Life Science Park

location_facility: Advanced Rheumatology & Arthritis Research Center, P.C

location_facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

location_facility: Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Unidad Reumatologica Las Americas, S.C. P.

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Paramount Medical Research & Consulting, Llc

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

title: Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

location_country:
Germany
Italy
Poland
Argentina
Japan
Brazil
Netherlands
Austria
Mexico
United States
Korea, Republic of
Spain
South Africa
Taiwan
Canada
Russian Federation
France


title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Drisapersen in Subjects With Duchenne Muscular Dystrophy.

summary: This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

status: No longer available

study_type: Expanded Access

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
France
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Queen Fabiola Children's University Hospital

location_facility: Hadassah, Hebrew University Medical Center

location_facility: Universitair Ziekenhuis Gent, Afdeling Neurologie

location_facility: Royal Children's Hosital, Children's Neuroscience Centre

location_facility: Seoul National University Children's Hospital

location_facility: Hôpital de La Citadelle, Centre de référence des Maladies

location_facility: IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: National Center Hospital of Neurology and Psychiatry


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction

acronym: PRONTO

summary: This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

lead_sponsor: Prothena Biosciences Ltd.

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Austria
United States
Spain
Greece
France

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Texas; MD Anderson Cancer Center

location_facility: Froedtert & Medical College of Wisconsin, Cancer Center - Froedtert Hospital

location_facility: The University of Queensland - Princess Alexandra Hospital (PAH)

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda


lead_sponsor: Kite, A Gilead Company

summary:
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).

As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell Non Hodgkin Lymphoma (NHL).

location_facility: Monroe-Carell Jr. Children's Hospital at Vanderbilt

location_facility: Unité d'Oncologie et Hématologie Pédiatriques

location_facility: Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP

location_facility: Jurasz University Hospital 1; Collegium Medicum

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Virginia Health System, Pediatric Hematology/Oncology Clinic

location_facility: University Medical Center Hamburg-Eppendorf (UKE)

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Hopital Robert Debre - Sevice d'Hemato-immunologic

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: Medical College of Wisconsin (Administrative Offices)

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: Ann & Robert H. Lurie Children's Hospital

location_facility: Institut d'Hematologie et Oncologie Pediatrique

status: Recruiting

title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

enrollment_type: Anticipated

location_country:
Germany
Italy
Poland
Sweden
Netherlands
Belgium
United States
Spain
Czechia
Canada
France

ipd_sharing: No


acronym: HAVEN 1

summary: This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a 2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be stratified across Arms A and B according to the number of bleeds they experienced over the last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9 bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks after the last participant has enrolled in Arms A or B or until approximately 50 participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who previously participated in the non-interventional study BH29768 (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic bypassing agents who were unable to enroll in Arm C, prior to their closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will receive emicizumab prophylaxis from the start of the trial. All participants will continue to receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with recombinant activated factor VII (rFVIIa).

ReferenceCitation: Kruse-Jarres R, Peyvandi F, Oldenburg J, Chang T, Chebon S, Doral MY, Croteau SE, Lambert T, Kempton CL, Pipe SW, Ko RH, Trzaskoma B, Dhalluin C, Bienz NS, Niggli M, Lehle M, Paz-Priel I, Young G, Jimenez-Yuste V. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood Adv. 2022 Dec 27;6(24):6140-6150. doi: 10.1182/bloodadvances.2022007458.

oa_colors: green gold

evidence: open (via page says license)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_facility: Cornell Univ Medical College; Hematology-Oncolog

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Royal Prince Alfred Hospital; Haematology

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Univ of TX Health Science Ctr; Gulf States Hemo and Throm Ctr

location_facility: St Thomas' Hospital; Haemostasis & Thromboisis Centre

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Auckland City Hospital; Auckland Haemophilia Centre

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Pennsylvania State Hershey Medical Center; Division of Hematology/Oncology, H046

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: CTC North GmbH & Co. KG am Universitätsklinikum Hamburg-Eppendorf

location_facility: Oregon Health & Science Uni ; Dept of Pediatrics

location_facility: ALVAMED Lekarskie Gabinety Specjalistyczne

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: Groupe Hospitalier Necker Enfants Malades

title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Australia
Costa Rica
Japan
United States
Korea, Republic of
Spain
South Africa
Taiwan
France


lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.

ReferenceCitation: Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

ReferenceCitation: Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. Erratum In: BMC Neurol. 2020 Mar 13;20(1):90.

repository_institution: Leiden University - Leiden Repository

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

ReferenceCitation: Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

publisher_dissemination: Wiley

ReferenceCitation: Camporeale A, Kudrow D, Sides R, Wang S, Van Dycke A, Selzler KJ, Stauffer VL. A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurol. 2018 Nov 9;18(1):188. doi: 10.1186/s12883-018-1193-2.

location_facility: Jacksonville Center for Clinical Research

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

location_facility: New England Institute for Clinical Research

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

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

location_country:
Hungary
Belgium
United States
Canada
Puerto Rico
France


summary: The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

ReferenceType: result

ReferenceCitation: Oluwole OO, Shah BD, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia Treated with Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy [Abstract S1569]. The 23rd European Hematology Association (EHA) Congress 2018 14-17 June; Stockholm, Sweden.

ReferenceCitation: Sabatino M, Choi K, Chiruvolu V, Better M. Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 711]. Blood 2016;128 (22):1227.

ReferenceCitation: Shah B, Castro J, Gokbuget N, Kersten MJ, Hagenbeek T, Wierda W, et al. ZUMA-3: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of KTE-C19 Anti-CD19 CAR T Cells in Adult Subjects with Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (r/r ALL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3713.

ReferenceCitation: Shah B, Huynh V, Sender LS, Lee DW, Castro JE, Wierda WG, et al. High Rates of Minimal Residual Disease-Negative (MRD-) Complete Responses (CR) in Adult and Pediatric and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials. Blood 2016;128 (22):2803.

ReferenceCitation: Shah B, Stock W, Wierda W, Topp M, Kersten MJ, Houot R, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T cell Therapy in Adult Patients (Pts) With Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial: Preliminary Results of Novel Safety Interventions [Abstract ALL-025]. Clinical lymphoma, myeloma & leukemia 2017;17:S253.

ReferenceCitation: Shah B, Stock W, Wierda W, Topp MS, Kersten MJ, Houot R, et al. Preliminary Results of Novel Safety Interventions in Adult Patients (Pts) With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial. European Society for Medical Oncology (ESMO) Congress 2017.

ReferenceCitation: Shah B, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. KTE-C19 Chimeric Antigen Receptor (CAR) T Cell Therapy in Adults with High-Burden Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL): Updated Results from Phase 1/2 of ZUMA-3 [Abstract P523]. The 22nd European Hematology Association (EHA) Congress 2017 22-25 June; Madrid, Spain.

ReferenceCitation: Shah BD, Bishop MR, Oluwole OO, Logan A, Baer MR, Donnellan WB, et al. End of Phase I Results of ZUMA-3, A Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients (pts) with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract]. J Clin Oncol 2019;37 (15):7006.

ReferenceCitation: Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia: End of Phase 1 Results of ZUMA-3 [Abstract PS945]. HemaSphere 2019;3 (S1):426.

ReferenceCitation: Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL): Outcomes in Patients Who Were Treated with Prior Blinatumomab in ZUMA-3 [Abstract ALL-128]. Clinical lymphoma, myeloma & leukemia 2018;18 (Supplement 1):S184.

ReferenceCitation: Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients Treated With Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. ASCO; 2018 01-05 June; Chicago, IL.

ReferenceCitation: Shah BD, Stock W, Wierda WG, Oluwole O, Holmes H, Schiller GJ, et al. Phase 1 Results of ZUMA-3: KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 612]. Blood 2017;130 (Supplement 1):888.

ReferenceCitation: Shah BD, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. Updated results from ZUMA- 3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL) [Abstract 3024]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2017 02-06 June; Chicago, Illinois.

ReferenceCitation: Wierda WG, Bishop MR, Oluwole O, Logan AC, Baer MR, Donnellan WB, et al. Updated Phase 1 Results of Zuma-3: Kte-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia [Abstract 256]. Biol Blood Marrow Transplant 2019;25 (3):S185.

ReferenceCitation: Wierda WG, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, et al. Updated Phase 1 Results of Zuma-3: Kte-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia [Abstract]. Blood 2018;132 (Supplement 1):897.

ReferenceCitation: Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, O'Dwyer KM, Holmes H, Arellano ML, Ghobadi A, Pagel JM, Lin Y, Cassaday RD, Park JH, Abedi M, Castro JE, DeAngelo DJ, Malone AK, Mawad R, Schiller GJ, Rossi JM, Bot A, Shen T, Goyal L, Jain RK, Vezan R, Wierda WG. KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. Blood. 2021 Jul 8;138(1):11-22. doi: 10.1182/blood.2020009098.

oa_colors: green other

ReferenceCitation: Shah BD, Ghobadi A, Oluwole OO, Logan AC, Boissel N, Cassaday RD, Leguay T, Bishop MR, Topp MS, Tzachanis D, O'Dwyer KM, Arellano ML, Lin Y, Baer MR, Schiller GJ, Park JH, Subklewe M, Abedi M, Minnema MC, Wierda WG, DeAngelo DJ, Stiff P, Jeyakumar D, Feng C, Dong J, Shen T, Milletti F, Rossi JM, Vezan R, Masouleh BK, Houot R. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021 Aug 7;398(10299):491-502. doi: 10.1016/S0140-6736(21)01222-8. Epub 2021 Jun 4.

oa_host_type: closed

ReferenceCitation: Shah BD, Smith NJ, Feng C, Jeyakumar S, Castaigne JG, Faghmous I, Masouleh BK, Malone DC, Bishop MR. Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States. Adv Ther. 2022 Aug;39(8):3678-3695. doi: 10.1007/s12325-022-02201-6. Epub 2022 Jun 21.

location_facility: University Health Network - Princess Margaret

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of California Irvine Medical Center

location_facility: University of MD Greenbaum Comprehensive Cancer Center

location_facility: Hopital Pontchaillou - CHU de Rennes - Service d'Hematologie

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: University of California Los Angeles (UCLA)

location_facility: Washington University School of Medicine

title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

location_country:
Germany
Netherlands
United States
Canada
France

ipd_sharing: Yes


acronym: COLUMBUS-AMD

intervention_type: Biological

lead_sponsor: Bioeq GmbH

summary: The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

location_facility: University of Bonn, Department of Ophthalmology

title: Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Austria
Spain
Czechia
Ukraine
Russian Federation
France


lead_sponsor: Gilead Sciences

summary: This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.

ReferenceCitation: Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31.

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repositories_concat: PubMed Central;scholarworks.iupui.edu

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Stellbrink HJ, Arribas JR, Stephens JL, Albrecht H, Sax PE, Maggiolo F, Creticos C, Martorell CT, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e364-e372. doi: 10.1016/S2352-3018(19)30080-3. Epub 2019 May 5.

ReferenceCitation: Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.

evidence: open (via free pdf)

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.

ReferenceCitation: Johnson M, Taylor S, Wei X, Collins SE, Martin H. Hepatic Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide [Poster P061]. 25th Annual Conference of the British HIV Association; 2019 02-05 April; Bournemouth, United Kingdom.

ReferenceCitation: Gupta S, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. 96 Week Efficacy and Safety of B/F/TAF in Treatment-Naïve Adults and Adults ≥50 Years [Poster 502]. CROI 2019; 2019 04-07 March; Seattle, WA.

ReferenceCitation: Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.

ReferenceCitation: White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.

ReferenceCitation: Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories:
2f75rf68h
PubMed Central
RePEc

repositories_concat: 2f75rf68h;PubMed Central;RePEc

ReferenceCitation: Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.

ReferenceCitation: Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

ReferenceCitation: Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

ReferenceCitation: Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.

repository_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtrictabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.

ReferenceCitation: Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom.

ReferenceCitation: Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

ReferenceCitation: Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.

ReferenceCitation: Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

ReferenceCitation: Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naive Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

ReferenceCitation: Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.

ReferenceCitation: Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

ReferenceCitation: Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29- October 3; Virtual.

ReferenceCitation: Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG+F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.

location_facility: North Texas Infectious Diseases Consultants PA

location_facility: Cone Health Regional Center for Infectious Disease

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
United States
Spain
Dominican Republic
Canada
Puerto Rico
France


title: A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-Thalassemia

acronym: BELIEVE

summary:
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia.

The study is divided into the following periods:

Historical Period,
Screening/Run-in Period,
Double-blind Treatment Period (48 weeks),
Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks),
Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation
Post-treatment Follow-up Period

ReferenceCitation: Porter J. Beyond transfusion therapy: new therapies in thalassemia including drugs, alternate donor transplant, and gene therapy. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):361-370. doi: 10.1182/asheducation-2018.1.361.

ReferenceCitation: Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, Caruso V, Pietrangelo A, Longo F, Tartaglione I, Borgna-Pignatti C, Zhang X, Laadem A, Sherman ML, Attie KM. Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with beta-thalassemia. Blood. 2019 Mar 21;133(12):1279-1289. doi: 10.1182/blood-2018-10-879247. Epub 2019 Jan 7.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Cappellini MD, Taher AT. The use of luspatercept for thalassemia in adults. Blood Adv. 2021 Jan 12;5(1):326-333. doi: 10.1182/bloodadvances.2020002725.

ReferenceCitation: Cappellini MD, Viprakasit V, Taher AT, Georgiev P, Kuo KHM, Coates T, Voskaridou E, Liew HK, Pazgal-Kobrowski I, Forni GL, Perrotta S, Khelif A, Lal A, Kattamis A, Vlachaki E, Origa R, Aydinok Y, Bejaoui M, Ho PJ, Chew LP, Bee PC, Lim SM, Lu MY, Tantiworawit A, Ganeva P, Gercheva L, Shah F, Neufeld EJ, Thompson A, Laadem A, Shetty JK, Zou J, Zhang J, Miteva D, Zinger T, Linde PG, Sherman ML, Hermine O, Porter J, Piga A; BELIEVE Investigators. A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent beta-Thalassemia. N Engl J Med. 2020 Mar 26;382(13):1219-1231. doi: 10.1056/NEJMoa1910182.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

lead_sponsor: Celgene

collaborators: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Italy
Israel
United Kingdom
Australia
Tunisia
Lebanon
United States
Thailand
Greece
Malaysia
Turkey
Taiwan
Bulgaria
Canada
France

location_facility: Universita degli Studi di Cagliari - ASL8

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital

location_facility: General Hospital Georgios Gennimatas of Athens

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital

location_facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

location_facility: Azienda Ospedaliero Universitaria S. Luigi Gonzaga

location_facility: GH de Institut Catholique St. VincentHématologie

location_facility: Hospital Pulau Pinang c/o Penang Medical College

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD

location_facility: Fondazione Ca Granda IRCCS Ospedale Maggiore

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: General Children's Hospital "Agia Sophia"

location_facility: Hospital of the University of Pennsylvania

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

ReferenceCitation: Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347. Erratum In: J Antimicrob Chemother. 2019 Dec 1;74(12):3646-3647.

ReferenceCitation: Molina JM, Ward D, Brar I, Mills A, Stellbrink HJ, Lopez-Cortes L, Ruane P, Podzamczer D, Brinson C, Custodio J, Liu H, Andreatta K, Martin H, Cheng A, Quirk E. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e357-e365. doi: 10.1016/S2352-3018(18)30092-4. Epub 2018 Jun 18. Erratum In: Lancet HIV. 2018 Jun 22;:

ReferenceCitation: Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

repositories_institution: RePEc: Research Papers in Economics - RePEc

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
United States
Spain
Canada
Puerto Rico
France


title: A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

summary: This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

lead_sponsor: Axovant Sciences Ltd.

location_country:
Germany
Poland
Argentina
Australia
Croatia
Chile
Czechia
Canada
Serbia
France
Slovakia
United States
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Bulgaria


title: A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease

summary: This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.


title: An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus MEDI4736 in Patients With Locally Advanced and Unresectable or Metastatic Gastrointestinal or Thoracic Malignancies

summary: The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).

sponsor_collaborators:
Eli Lilly and Company
AstraZeneca

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

location_facility: University of Texas MD Anderson Cancer Center

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


title: A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

summary:
The aim of this study is to learn more about the following treatment options in adults with CIDP:

Subcutaneous self-infusion with HyQvia.
Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound.

The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C.

The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

collaborators: Takeda Development Center Americas, Inc.

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Croatia
Czechia
Canada
Serbia
France
Colombia
Slovakia
Denmark
United States
Italy
Norway
United Kingdom
Sweden
Mexico
Spain
Greece
Israel

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Complejo Medico de la Policia Federal Argentina Churruca Visca

location_facility: Instituto de Neurologia de Curitiba - Hospital Ecoville

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o.,

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Hospital das Clínicas da Faculdade de Medicina da UNICAMP

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense

location_facility: The Methodist Hospital Research Institute

location_facility: Univerzitna nemocnica Bratislava Nemocnica ak. L. Derera, II. Neurologicka klinika

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza


title: A Phase 2 Multicenter, Randomized, Placebo Controlled, Double Blind Study to Assess the Safety and Efficacy of CC-486 (Oral Azacitidine) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Plus Placebo in Subjects With Previously Treated Locally Advanced or Metastatic Non-small Cell Lung Cancer

summary: The purpose of this study is to determine whether the combination therapy of CC-486 (oral azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab alone in patients with previously treated locally advanced or metastatic non-small cell lung cancer.

location_country:
Germany
Italy
United States
Spain
Greece
France

location_facility: North Shore Hematology Oncology Associates


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.

ReferenceCitation: Chilvers MA, Davies JC, Milla C, Tian S, Han Z, Cornell AG, Owen CA, Ratjen F. Long-term safety and efficacy of lumacaftor-ivacaftor therapy in children aged 6-11 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a phase 3, open-label, extension study. Lancet Respir Med. 2021 Jul;9(7):721-732. doi: 10.1016/S2213-2600(20)30517-8. Epub 2021 Jan 28. Erratum In: Lancet Respir Med. 2021 Apr;9(4):e38.

repository_institution: Imperial College London - Spiral

title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

location_country:
Germany
United Kingdom
Denmark
Australia
Sweden
Belgium
United States
Canada
France


title: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

acronym: FANTOM II

summary: The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

ReferenceCitation: Chevalier B, Abizaid A, Carrie D, Frey N, Lutz M, Weber-Albers J, Dudek D, Weng SC, Akodad M, Anderson J, Stone GW. Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. Circ Cardiovasc Interv. 2019 Jun;12(6):e007283. doi: 10.1161/CIRCINTERVENTIONS.118.007283. Epub 2019 Jun 10.

lead_sponsor: REVA Medical, Inc.

location_country: Germany Poland Denmark Australia Brazil Netherlands Belgium France

location_facility: Oddział Kardiologii Inwazyjnej I Katedra

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Krakowskie Centrum Kardiologii Inwazyjnej

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Prince of Wales Hospital (Eastern Heart)

intervention_type: Device


title: International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

acronym: SAGIT

summary:
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.

SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T.

The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.

study_type: Observational

time_perspective: Other

ReferenceCitation: Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. International Multicenter Validation Study of the SAGIT(R) Instrument in Acromegaly. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3555-3568. doi: 10.1210/clinem/dgab536.

evidence: open (via crossref license, author manuscript)

publisher_dissemination: The Endocrine Society

ReferenceCitation: Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT(R) validation study. Pituitary. 2019 Oct;22(5):476-487. doi: 10.1007/s11102-019-00977-5.

repository_institution: Servicio Gallego de Salud (SERGAS) - RUNA. Repositorio Institucional del Sergas

repositories_concat: PubMed Central;runa.sergas.gal

location_country:
Germany
Italy
United Kingdom
Denmark
Brazil
Netherlands
Belgium
United States
Spain
France

location_facility: Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2

location_facility: Endocrinology and Metabolism Churchill Hospital

location_facility: Endocrinology, University Hospital, Policlinica Gemelu

location_facility: Hospital de Condia(CHUS) RVA Ramon Baltar S/N

location_facility: Azienda Ospedaliero Universitar a Fedderico II

location_facility: Department of Clinical Medicine - The Department of Endocrinology and Diabetes

location_facility: University Hospital, Dept of Endocrinology


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis

summary:
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable.

Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.

ReferenceCitation: Schmidt WA, Dasgupta B, Luqmani R, Unizony SH, Blockmans D, Lai Z, Kurrasch RH, Lazic I, Brown K, Rao R. A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis. Rheumatol Ther. 2020 Dec;7(4):793-810. doi: 10.1007/s40744-020-00227-2. Epub 2020 Aug 25.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

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

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
New Zealand
Hungary
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
Bulgaria
France


title: A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects With Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

summary:
A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis.

Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo.

Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26.

Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted.

Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card.

Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology.

In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed.

Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.

lead_sponsor: Atlantic Pharmaceuticals Ltd

location_country:
Ireland
Italy
Israel
United Kingdom
Netherlands
Switzerland
Belgium
United States
Canada
France

location_facility:
Site Reference ID/Investigator# 1006
Site Reference ID/Investigator# 0503
Site Reference ID/Investigator# 0102
Site Reference ID/Investigator# 0205
Site Reference ID/Investigator# 0601
Site Reference ID/Investigator# 0404
Site Reference ID/Investigator# 0902
Site Reference ID/Investigator# 1009
Site Reference ID/Investigator# 1004
Site Reference ID/Investigator# 1010
Site Reference ID/Investigator# 0801
Site Reference ID/Investigator# 1003
Site Reference ID/Investigator# 1007
Site Reference ID/Investigator# 0101
Site Reference ID/Investigator# 0804
Site Reference ID/Investigator# 0502
Site Reference ID/Investigator# 0802
Site Reference ID/Investigator# 0602
Site Reference ID/Investigator# 0803
Site Reference ID/Investigator# 0506
Site Reference ID/Investigator# 0202
Site Reference ID/Investigator# 0504
Site Reference ID/Investigator# 0501
Site Reference ID/Investigator# 0505
Site Reference ID/Investigator# 0204
Site Reference ID/Investigator# 0103
Site Reference ID/Investigator# 0403
Site Reference ID/Investigator#1011
Site Reference ID/Investigator# 0402
Site Reference ID/Investigator# 0901
Site Reference ID/Investigator# 0203
Site Reference ID/Investigator # 1005
Site Reference ID/Investigator# 1008
Site Reference ID/Investigator# 1002
Site Reference ID/Investigator#1012
Site Reference ID/Investigator# 0201
Site Reference ID/Investigator# 0301
Site Reference ID/Investigator# 0701
Site Reference ID/Investigator# 1001
Site Reference ID/Investigator# 0302
Site Reference ID/Investigator# 0401


title: An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit

summary:
This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carcinoma can also participate. No standard treatment exists for this rare and aggressive form of cancer.

The purpose of this study is to find out the highest dose of BI 894999 that people can tolerate.

BI 894999 is tested for the first time in humans. Participants take tablets once daily. The study also tests whether participants can tolerate BI 894999 better when taken continuously or with breaks in between.

Participants can stay in the study as long as they benefit from the treatment and can tolerate it.

The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Belgium
United States
Korea, Republic of
Spain
France

location_facility: The University of Texas MD Anderson Cancer Center


summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

ReferenceCitation: Ratjen F, Hug C, Marigowda G, Tian S, Huang X, Stanojevic S, Milla CE, Robinson PD, Waltz D, Davies JC; VX14-809-109 investigator group. Efficacy and safety of lumacaftor and ivacaftor in patients aged 6-11 years with cystic fibrosis homozygous for F508del-CFTR: a randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2017 Jul;5(7):557-567. doi: 10.1016/S2213-2600(17)30215-1. Epub 2017 Jun 9. Erratum In: Lancet Respir Med. 2017 Aug;5(8):e28.

title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation


title: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

acronym: MOTION

summary: This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).

ReferenceType: background

ReferenceCitation: Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.

ReferenceCitation: Phillips DR, Milim SJ, Nathanson HG, Haselkorn JS. Experience with laparoscopic leiomyoma coagulation and concomitant operative hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Aug;4(4):425-33. doi: 10.1016/s1074-3804(05)80034-9.

ReferenceCitation: Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.

ReferenceCitation: COOPER IS, LEE AS. Cryostatic congelation: a system for producing a limited, controlled region of cooling or freezing of biologic tissues. J Nerv Ment Dis. 1961 Sep;133:259-63. No abstract available.

ReferenceCitation: Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. doi: 10.1016/s0090-4295(02)01681-3.

ReferenceCitation: Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z.

ReferenceCitation: Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g.

ReferenceCitation: Gage AA. Current progress in cryosurgery. Cryobiology. 1988 Oct;25(5):483-6. doi: 10.1016/0011-2240(88)90056-9.

ReferenceCitation: Gage AA, Guest K, Montes M, Caruana JA, Whalen DA Jr. Effect of varying freezing and thawing rates in experimental cryosurgery. Cryobiology. 1985 Apr;22(2):175-82. doi: 10.1016/0011-2240(85)90172-5.

ReferenceCitation: Homasson JP, Thiery JP, Angebault M, Ovtracht L, Maiwand O. The operation and efficacy of cryosurgical, nitrous oxide-driven cryoprobe. I. Cryoprobe physical characteristics: their effects on cell cryodestruction. Cryobiology. 1994 Jun;31(3):290-304. doi: 10.1006/cryo.1994.1035.

ReferenceCitation: Hamilton A, Hu J. An electronic cryoprobe for cryosurgery using heat pipes and thermoelectric coolers: a preliminary report. J Med Eng Technol. 1993 May-Jun;17(3):104-9. doi: 10.3109/03091909309016215.

ReferenceCitation: Rabin Y, Julian TB, Wolmark N. A compact cryosurgical apparatus for minimally invasive procedures. Biomed Instrum Technol. 1997 May-Jun;31(3):251-8.

ReferenceCitation: Rabin Y, Coleman R, Mordohovich D, Ber R, Shitzer A. A new cryosurgical device for controlled freezing. Cryobiology. 1996 Feb;33(1):93-105. doi: 10.1006/cryo.1996.0010.

ReferenceCitation: Rand RW, Rand RP, Eggerding FA, Field M, Denbesten L, King W, Camici S. Cryolumpectomy for breast cancer: an experimental study. Cryobiology. 1985 Aug;22(4):307-18. doi: 10.1016/0011-2240(85)90178-6.

ReferenceCitation: Miller RH, Mazur P. Survival of frozen-thawed human red cells as a function of cooling and warming velocities. Cryobiology. 1976 Aug;13(4):404-14. doi: 10.1016/0011-2240(76)90096-1.

ReferenceCitation: Gage AA, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Cryobiology. 2009 Dec;59(3):229-43. doi: 10.1016/j.cryobiol.2009.10.001. Epub 2009 Oct 13.

ReferenceCitation: McTaggart RA, Dupuy DE. Thermal ablation of lung tumors. Tech Vasc Interv Radiol. 2007 Jun;10(2):102-13. doi: 10.1053/j.tvir.2007.09.004.

ReferenceCitation: Callstrom MR, Charboneau JW. Image-guided palliation of painful metastases using percutaneous ablation. Tech Vasc Interv Radiol. 2007 Jun;10(2):120-31. doi: 10.1053/j.tvir.2007.09.003.

ReferenceCitation: McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. doi: 10.1002/14651858.CD001793.

ReferenceCitation: Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. doi: 10.1148/radiol.2412051247.

ReferenceCitation: Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.

ReferenceCitation: Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Gronemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. doi: 10.1200/JCO.2004.03.097.

ReferenceCitation: Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97. doi: 10.1148/radiol.2241011613.

ReferenceCitation: Belfiore G, Tedeschi E, Ronza FM, Belfiore MP, Della Volpe T, Zeppetella G, Rotondo A. Radiofrequency ablation of bone metastases induces long-lasting palliation in patients with untreatable cancer. Singapore Med J. 2008 Jul;49(7):565-70.

ReferenceCitation: Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5):dju082. doi: 10.1093/jnci/dju082.

ReferenceCitation: Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5.

ReferenceCitation: Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. doi: 10.1067/j.cpradiol.2007.05.001.

ReferenceCitation: Maiwand MO. The role of cryosurgery in palliation of tracheo-bronchial carcinoma. Eur J Cardiothorac Surg. 1999 Jun;15(6):764-8. doi: 10.1016/s1010-7940(99)00121-9.

ReferenceCitation: Maiwand MO, Homasson JP. Cryotherapy for tracheobronchial disorders. Clin Chest Med. 1995 Sep;16(3):427-43. Erratum In: Clin Chest Med 1995 Dec;16(4):ix.

ReferenceCitation: Sanderson DR, Neel HB 3rd, Fontana RS. Bronchoscopic cryotherapy. Ann Otol Rhinol Laryngol. 1981 Jul-Aug;90(4 Pt 1):354-8. doi: 10.1177/000348948109000414.

ReferenceCitation: Cozzi PJ, Lynch WJ, Collins S, Vonthethoff L, Morris DL. Renal cryotherapy in a sheep model; a feasibility study. J Urol. 1997 Feb;157(2):710-2.

ReferenceCitation: Gage AA, Fazekas G, Riley EE Jr. Freezing injury to large blood vessels in dogs. With comments on the effect of experimental freezing of bile ducts. Surgery. 1967 May;61(5):748-54. No abstract available.

ReferenceCitation: Gage AM, Montes M, Gage AA. Freezing the canine thoracic aorta in situ. J Surg Res. 1979 Nov;27(5):331-40. doi: 10.1016/0022-4804(79)90149-5. No abstract available.

ReferenceCitation: Ladd AP, Rescorla FJ, Baust JG, Callahan M, Davis M, Grosfeld JL. Cryosurgical effects on growing vessels. Am Surg. 1999 Jul;65(7):677-82.

ReferenceCitation: Mandeville AF, McCabe BF. Some observations on the cryobiology of blood vessels. Laryngoscope. 1967 Aug;77(8):1328-50. doi: 10.1288/00005537-196708000-00009. No abstract available.

ReferenceCitation: Callstrom MR, Dupuy DE, Solomon SB, Beres RA, Littrup PJ, Davis KW, Paz-Fumagalli R, Hoffman C, Atwell TD, Charboneau JW, Schmit GD, Goetz MP, Rubin J, Brown KJ, Novotny PJ, Sloan JA. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013 Mar 1;119(5):1033-41. doi: 10.1002/cncr.27793. Epub 2012 Oct 12.

ReferenceCitation: Cleeland CS. The measurement of pain from metastatic bone disease: capturing the patient's experience. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6236s-6242s. doi: 10.1158/1078-0432.CCR-06-0988.

ReferenceCitation: Jennings JW, Prologo JD, Garnon J, Gangi A, Buy X, Palussiere J, Kurup AN, Callstrom M, Genshaft S, Abtin F, Huang AJ, Iannuccilli J, Pilleul F, Mastier C, Littrup PJ, de Baere T, Deschamps F. Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study. Radiol Imaging Cancer. 2021 Feb 12;3(2):e200101. doi: 10.1148/rycan.2021200101. eCollection 2021 Mar.

evidence: oa journal (via observed oa rate)

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

repository_normalized: HAL

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

publisher_dissemination: Radiological Society of North America (RSNA)

lead_sponsor: Boston Scientific Corporation

location_country:
United States
France

location_facility:
Massachusetts General Hospital
Emory University Hospital
Institut Bergonié
Centre Léon Bérard
Crittenton Hospital
UCLA Ronald Reagan Medical Center
University Hospital of Strasbourg
Institut Gustave Roussy
Mayo Clinic Rochester
Rhode Island Hospital
Washington University in St. Louis


acronym: C-OPTIMISE

intervention_type: Other

lead_sponsor: UCB BIOSCIENCES GmbH

summary: Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.

ReferenceCitation: Landewe RB, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch FE, Gaffney K, Bauer L, Hoepken B, Davies OR, de Peyrecave N, Thomas K, Gensler LS. Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction. Ann Rheum Dis. 2020 Jul;79(7):920-928. doi: 10.1136/annrheumdis-2019-216839. Epub 2020 May 7. Erratum In: Ann Rheum Dis. 2020 Sep;79(9):e120.

ReferenceCitation: Landewe R, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch F, Gaffney K, Bauer L, Hoepken B, de Peyrecave N, Thomas K, Gensler LS. Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE. Rheumatol Ther. 2020 Sep;7(3):581-599. doi: 10.1007/s40744-020-00214-7. Epub 2020 Jun 11.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of East Anglia - UEA Digital Repository

sponsor_collaborators:
UCB BIOSCIENCES GmbH
Parexel

title: A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Netherlands
Belgium
United States
Spain
Turkey
Taiwan
Czechia
Bulgaria
France


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

location_facility: Oklahoma Ctr For Arthritis Therapy And Research, Inc.

location_facility: Rheumatologische Schwerpunktpraxis Dr. Zinke

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Hospital General De Agudos J.M. Ramos Mejia

location_facility: Clinical Research Center Of Reading, Llp

location_facility: Gemeinschaftspraxis Drs. von Hinueber u Demary

location_facility: Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch

location_facility: Arthritis Clinic Of Northern Virginia, P.C.

location_facility: Instytut Reumatologii, I Klinika Reumatologii

location_facility: Arthritis And Osteoporosis Associates, Pa

location_facility: Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken

location_facility: Valerius Medical Group and Research Center

location_facility: Centre De Recherche Musculo-Squelettique

location_facility: Rheumatology Associates Of Central Florida, P.A.

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: SANUS Szpital Specjalistyczny Sp. z o.o.

location_facility: Slaski Szpital Reumatologiczno - Rehabilitacyjny

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

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Centro De Investigaciones Reumatologicas

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Fundacion Instituto de Reumatologia Fernando Chalem

location_facility: Inland Rheumatology Clinical Trials Inc.

location_facility: Hospital Privado-Centro Medico De Cordoba S.A.

title: A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Colombia
Hungary
Qatar
United States
Romania
Peru
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Monaco
Taiwan
Russian Federation
Israel


title: A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

summary: The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

ReferenceCitation: Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Germany
Italy
Poland
Hungary
Argentina
Israel
Australia
Netherlands
Mexico
Belgium
United States
Korea, Republic of
Spain
Czechia
Ukraine
Russian Federation
France

location_facility:
Teva Investigational Site 13345
Teva Investigational Site 13357
Teva Investigational Site 32621
Teva Investigational Site 13356
Teva Investigational Site 20055
Teva Investigational Site 37058
Teva Investigational Site 87020
Teva Investigational Site 21103
Teva Investigational Site 32573
Teva Investigational Site 13354
Teva Investigational Site 38085
Teva Investigational Site 13370
Teva Investigational Site 50382
Teva Investigational Site 21105
Teva Investigational Site 31158
Teva Investigational Site 50356
Teva Investigational Site 50418
Teva Investigational Site 13363
Teva Investigational Site 87024
Teva Investigational Site 13362
Teva Investigational Site 53321
Teva Investigational Site 13377
Teva Investigational Site 31160
Teva Investigational Site 54132
Teva Investigational Site 54133
Teva Investigational Site 13371
Teva Investigational Site 13368
Teva Investigational Site 35185
Teva Investigational Site 78092
Teva Investigational Site 13351
Teva Investigational Site 37059
Teva Investigational Site 78089
Teva Investigational Site 21102
Teva Investigational Site 87021
Teva Investigational Site 30154
Teva Investigational Site 21090
Teva Investigational Site 21106
Teva Investigational Site 78091
Teva Investigational Site 20087
Teva Investigational Site 32580
Teva Investigational Site 13348
Teva Investigational Site 38084
Teva Investigational Site 13352
Teva Investigational Site 13346
Teva Investigational Site 20052
Teva Investigational Site 35186
Teva Investigational Site 58246
Teva Investigational Site 50417
Teva Investigational Site 32622
Teva Investigational Site 58235
Teva Investigational Site 20057
Teva Investigational Site 87025
Teva Investigational Site 13342
Teva Investigational Site 80084
Teva Investigational Site 50358
Teva Investigational Site 50385
Teva Investigational Site 80091
Teva Investigational Site 53318
Teva Investigational Site 58240
Teva Investigational Site 53323
Teva Investigational Site 58245
Teva Investigational Site 58248
Teva Investigational Site 31159
Teva Investigational Site 80082
Teva Investigational Site 13367
Teva Investigational Site 20056
Teva Investigational Site 58244
Teva Investigational Site 80083
Teva Investigational Site 58243
Teva Investigational Site 53320
Teva Investigational Site 13343
Teva Investigational Site 21094
Teva Investigational Site 13347
Teva Investigational Site 21100
Teva Investigational Site 87022
Teva Investigational Site 50419
Teva Investigational Site 58251
Teva Investigational Site 87023
Teva Investigational Site 51233
Teva Investigational Site 58237
Teva Investigational Site 58242
Teva Investigational Site 20066
Teva Investigational Site 58239
Teva Investigational Site 80085
Teva Investigational Site 53358
Teva Investigational Site 53317
Teva Investigational Site 31161
Teva Investigational Site 21101
Teva Investigational Site 78097
Teva Investigational Site 35189
Teva Investigational Site 21093
Teva Investigational Site 50384
Teva Investigational Site 20051
Teva Investigational Site 50383
Teva Investigational Site 78093
Teva Investigational Site 20050
Teva Investigational Site 30152
Teva Investigational Site 50386
Teva Investigational Site 58249
Teva Investigational Site 53316
Teva Investigational Site 51253
Teva Investigational Site 32578
Teva Investigational Site 13366
Teva Investigational Site 51232
Teva Investigational Site 13350
Teva Investigational Site 13344
Teva Investigational Site 35187
Teva Investigational Site 53319
Teva Investigational Site 13358
Teva Investigational Site 51254
Teva Investigational Site 58250
Teva Investigational Site 20058
Teva Investigational Site 13365
Teva Investigational Site 58238
Teva Investigational Site 13372
Teva Investigational Site 21091
Teva Investigational Site 32579
Teva Investigational Site 20059
Teva Investigational Site 58241
Teva Investigational Site 13349
Teva Investigational Site 32574
Teva Investigational Site 32576
Teva Investigational Site 13369
Teva Investigational Site 78090
Teva Investigational Site 50357
Teva Investigational Site 53322
Teva Investigational Site 21104


title: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

summary: The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

ReferenceCitation: Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6):21m14318. doi: 10.4088/JCP.21m14318.

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: Ochs-Ross R, Wajs E, Daly EJ, Zhang Y, Lane R, Lim P, Drevets WC, Steffens DC, Sanacora G, Jamieson C, Hough D, Manji H, Singh JB. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study. Am J Geriatr Psychiatry. 2022 May;30(5):541-556. doi: 10.1016/j.jagp.2021.09.014. Epub 2021 Oct 6.

ReferenceCitation: Wajs E, Aluisio L, Holder R, Daly EJ, Lane R, Lim P, George JE, Morrison RL, Sanacora G, Young AH, Kasper S, Sulaiman AH, Li CT, Paik JW, Manji H, Hough D, Grunfeld J, Jeon HJ, Wilkinson ST, Drevets WC, Singh JB. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020 Apr 28;81(3):19m12891. doi: 10.4088/JCP.19m12891.

ReferenceCitation: Nijs M, Wajs E, Aluisio L, Turkoz I, Daly E, Janik A, Borentain S, Singh JB, DiBernardo A, Wiegand F. Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data. Int J Neuropsychopharmacol. 2020 Jul 29;23(7):426-433. doi: 10.1093/ijnp/pyaa027.

lead_sponsor: Janssen Research & Development, LLC

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