title: A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Versus Specified Physician's Choice in Patients ≥ 60 Years Old With Relapsed or Refractory Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy and/or Transplantation

acronym: SOPRA

summary: This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

ReferenceCitation: Sweet K, Bhatnagar B, Döhner H, Donnellan W, Frankfurt O, Heuser M, Kota V, Liu H, Raffoux E, Roboz GJ, Röllig C, Showel MM, Strickland SA Jr, Vives S, Tang S, Unger TJ, Joshi A, Shen Y, Alvarez MJ, Califano A, Crochiere M, Landesman Y, Kauffman M, Shah J, Shacham S, Savona MR, Montesinos P. A 2:1 randomized, open-label, phase II study of selinexor vs. physician's choice in older patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2021 Dec;62(13):3192-3203. doi: 10.1080/10428194.2021.1950706. Epub 2021 Jul 29.

lead_sponsor: Karyopharm Therapeutics Inc

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

location_facility: Abteilung Hämatologie, internistische Onkologie und Hämostaseologie

location_facility: Royal Liverpool University Hospital, Dept of Cellular and Molecular Physiology, Molecular and Clinical Cancer Medicine

location_facility: Milton S. Hershey Medical Center / Penn State

location_facility: UNIVERSITY HOSPITAL OF MÜNSTER Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii

location_facility: Tennessee Oncology/Sarah Cannon Research Institute

location_facility: Universitair Medisch Centrum Groningen Department of Haematology

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Radboud University Medical Center Department of Haematology (476)

location_facility: University of Massachusetts Medical School

location_facility: AORN Cardarelli / UOSC di Ematologia con TMO

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa Spraw Wewnętrznych

location_facility: Hull and East Yorkshire Hospitals NHS Trust Queens Centre for Oncology and Haematology

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Stanford Cancer Institute / Stanford University

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

location_facility: Jonsson Comprehensive Cancer Center / University of California, Los Angeles

location_facility: New York Presbyterian Hospital / Weill Cornell Medical College

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Sir Mortimer B. Davis Jewish General Hospital / McGill University

location_facility: Institut Universitaire du Cancer Toulouse

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: UNIVERSITÄTSKLINIKUM TU DRESDEN Medizinische Klinik und Poliklinik I,

location_facility: Westchester Medical Center / New York Medical College

location_facility: Texas Transplant Institute/Sarah Cannon Research Institute

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Winship Cancer Institute / Emory University

location_facility: Odense University Hospital, Department of Hematology

location_facility: Colorado Blood Cancer Institute/Sarah Cannon Research Institute

location_facility: Stellvertretende Klinikleiterin Charité, Campus Benjamin Franklin

location_facility: Department of Haematology, National University Hospital, Rigshospitalet

location_facility: Ev. Diakonie-Krankenhaus Gemeinnutzige GMBH Medizinische Klinik 2

location_facility: Ninewells Hospital and Medical School NHS Tayside

location_facility: Medizinische Hochschule Hannover (Hannover Medical School) Dept. of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation

location_facility: AMC, Academisch Medisch Centrum Afdeling Klinische Hematologie

location_facility: Plymouth Hospitals NHS Trust/Derriford Hospital

location_facility: Sidney Kimmel Comprehensive Cancer Center / John Hopkins University

location_facility: Hospital Universitario de Salamanca Servicio de Hematologia

location_facility: Vanderbilt-Ingram Cancer Center / Vanderbilt University


status: Active, not recruiting

primary_purpose: Treatment

acronym: ALEX

intervention_type: Drug

title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

study_completion_date_type: Anticipated

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Dziadziuszko R, Peters S, Mok T, Camidge DR, Gadgeel SM, Ou SI, Konopa K, Noé J, Nowicka M, Bordogna W, Morcos PN, Smoljanovic V, Shaw AT. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. Clin Cancer Res. 2022 May 2;28(9):1800-1808. doi: 10.1158/1078-0432.CCR-21-2840.

ReferenceCitation: Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Pérol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanović V, Hilton M, Ruf T, Noé J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11.

ReferenceCitation: Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Pérol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nüesch E, Balas B, Camidge DR. Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study. Ann Oncol. 2018 Nov 1;29(11):2214-2222. doi: 10.1093/annonc/mdy405.

ReferenceCitation: Burudpakdee C, Wong W, Seetasith A, Corvino FA, Yeh W, Gubens M. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9.

ReferenceCitation: Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Pérol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.

enrollment_type: Actual

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Costa Rica
Poland
Hong Kong
Portugal
Russian Federation
Australia
Israel
Turkey
Mexico
Singapore
Egypt
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Guatemala
China
Germany
Taiwan
New Zealand
Thailand
Korea, Republic of
France
Chile

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

location_facility: Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Institute for pulmonary diseases of Vojvodina

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Dnipropetrovsk State Medical Academy; Chemotherapy Department

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación

location_facility: CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: University Clinical Center Sarajevo;Institute of oncology

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Klinik Löwenstein gGmbH Medizinische Klinik II

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Seoul National University Bundang Hospital

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Birmingham Heartlands Hospital; Dept of Oncology

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Monash Health Translational Precinct; Clinical Trials Centre, Level 3

location_facility: University Clinical Center Sarajevo;Clinic for Pulmonary disease

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

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

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Queen Elizabeth Hospital; Medical Oncology

location_facility: St. Mary's Hospital Regional Cancer Center

summary: This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)

summary: This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Alpalhão M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov 5. doi: 10.1007/s40259-022-00558-2. [Epub ahead of print]

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

ReferenceCitation: Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.

ReferenceCitation: Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.

ReferenceCitation: Thaçi D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Portugal
Austria
Australia
Israel
Turkey
Norway
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
Korea, Republic of
France
Netherlands

status_simplified: Completed


title: A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Darbepoetin Alfa Comparator in the Long Term Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease in Europe and Asia Pacific

acronym: DIALOGUE 3

summary:
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this extension study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.

lead_sponsor: Bayer

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Hungary
Korea, Republic of
France
Israel
Turkey
Romania
Japan
Germany
Bulgaria

location_facility:
Ankara Univ. Medical Faculty
Sifa University Medical Faculty
Baskent University Medical Faculty

intervention_type: Biological


type: Other Identifier

type: Registry Identifier

title: A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)

acronym: guardian™ 5

summary: This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Slovenia
Greece
Austria
Italy
Netherlands
Spain
Switzerland
Sweden
Hungary
United States
France
Germany
Slovakia
Czechia


title: A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy

summary: The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.

ReferenceCitation: Wechsler ME, Akuthota P, Jayne D, Khoury P, Klion A, Langford CA, Merkel PA, Moosig F, Specks U, Cid MC, Luqmani R, Brown J, Mallett S, Philipson R, Yancey SW, Steinfeld J, Weller PF, Gleich GJ; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017 May 18;376(20):1921-1932. doi: 10.1056/NEJMoa1702079.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Belgium
Japan
Germany


title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

acronym: OlympiAD

summary: This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

ReferenceCitation: Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4. Erratum in: N Engl J Med. 2017 Oct 26;377(17 ):1700.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Poland
Taiwan
Romania
Spain
Italy
Russian Federation
United Kingdom
Switzerland
Hungary
Korea, Republic of
United States
France
China
Peru
Mexico
Japan
Turkey
Bulgaria
Czechia


title: A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

summary: This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

ReferenceCitation: Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int J Hepatol. 2020 Jan 25;2020:5421632. doi: 10.1155/2020/5421632. eCollection 2020.

ReferenceCitation: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.

lead_sponsor: Eisai Inc.

location_country:
Brazil
Romania
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
United States
France
China
Israel
Belgium
Japan
Germany
Czechia


acronym: SELENE

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Brazil
Spain
United Kingdom
Russian Federation
Australia
Argentina
Ukraine
Sweden
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Puerto Rico
Turkey

summary: The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.


title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

acronym: SPIRE-LDL

summary: This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

ReferenceCitation: Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.

ReferenceCitation: Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul - Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.

ReferenceCitation: Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.

lead_sponsor: Pfizer

location_country:
Taiwan
Romania
Spain
United Kingdom
Russian Federation
Mexico
Canada
Lithuania
Hungary
United States
France
Colombia

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Centro Hospitalario Mac, S.A. De C.V. (Emergencies)

location_facility: Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie

location_facility: Southern Health & Social Care Trust, Craigavon Area Hospital

location_facility: North Texas Healthcare System, Dallas VAMC

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca

location_facility: Fleming Island Center for Clinical Research

location_facility: Stroke Prevention & Atherosclerosis Research Centre (SPARC)

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW

location_facility: Metabolic and Atherosclerosis Research Center

location_facility: Synexus Midlands Clinical Research Centre

location_facility: The Bradford on Avon & Melksham Health Partnership

location_facility: HealthEast St. Joseph's Hospital Pharmacy

location_facility: Municipal Institution of Healthcare "City Clinical Hospital 12

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Fundacion Centro de Investigaciones Biomedicas RIESCARD

location_facility: Synexus North East Clinical Research Centre

location_facility: London Road Diagnostic Clinic and Medical Centre

location_facility: Instituto de Diabetes, Obesidad y Nutricion S.C.

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: The Lindner Center for Research and Education at The Christ Hospital

location_facility: Hospital Universitario Sant Joan de Reus

location_facility: Synexus North East Clinical Research Centre-Hexham General Hospital

location_facility: Magyar Imre Korhaz, Belgyogyaszati Szakrendeles

location_facility: East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School

location_facility: Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular

location_facility: Florida Institute For Clinical Research, LLC

location_facility: Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí S.C.

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz

location_facility: Metabolic Research Institute Incorporated

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Hospital Angeles Centro Medico del Potosi (Emergencies)

location_facility: South Miami Clinical Research Center, LLC

location_facility: Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice

location_facility: Sentral Clinical Research Services - Admin Only

location_facility: Hospital Clinico Universitario Miguel Servet; Medicina Interna

location_facility: Asociacion IPS Medicos InterniStas de Caldas

location_facility: LMC Research Inc. d.b.a. Manna Research Inc.

location_facility: Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna

location_facility: IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.

location_facility: California Medical Research Associates Inc.

location_facility: Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios

location_facility: East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic

location_facility: Northmed Clinical Research Ltd, Randalstown Health Centre

location_facility: Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA

location_facility: Morton Plant Mease Health Care, Inc. Cardiovascular Research

location_facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Atlanta Center for Clinical Research / Internal Medicine

location_facility: New Orleans Center for Clinical Research

location_facility: Arch Health Partners Clinical Research Department

location_facility: Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)

location_facility: Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.

location_facility: Centro de Investigaciones Clinicas S.A.S

location_facility: East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA

location_facility: Clinical Research Institute of Southern Oregon, PC

location_facility: KCUMB Center for Community and Clinical Research

location_facility: FSAEI of Higher Education "People's Friendship University of Russia",

location_facility: The University of Iowa - College of Public Health - Preventive Intervention Center

location_facility: Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham

location_facility: East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi

location_facility: Centro de Diagnostico Cardiologico LTDA.

location_facility: National Clinical Research-Richmond, Inc.

location_facility: Detweiler Family Medicine and Associates, PC

location_facility: Hospital Universitario La Paz; Unidad Metabolico-Vascular

intervention_type: Other


title: A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Nielsen M, Presti M, Sztupinszki Z, Jensen AWP, Draghi A, Chamberlain CA, Schina A, Yde CW, Wojcik J, Szallasi Z, Crowther MD, Svane IM, Donia M. Coexisting Alterations of MHC Class I Antigen Presentation and IFNγ Signaling Mediate Acquired Resistance of Melanoma to Post-PD-1 Immunotherapy. Cancer Immunol Res. 2022 Oct 4;10(10):1254-1262. doi: 10.1158/2326-6066.CIR-22-0326.

location_country:
Denmark
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
Switzerland
United Kingdom
United States
France
Norway
Japan
Germany

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Washington University School Of Medicine

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: University Of Washington Cancer Care Alliance

location_facility: Lehigh Valley Hospital and Health Network

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Advocate Health and Hospitals Corporation

summary:
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.


title: APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy-FAP)

summary: The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

ReferenceCitation: Quan D, Obici L, Berk JL, Ando Y, Aldinc E, White MT, Adams D. Impact of baseline polyneuropathy severity on patisiran treatment outcomes in the APOLLO trial. Amyloid. 2022 Sep 18:1-10. doi: 10.1080/13506129.2022.2118043. [Epub ahead of print]

ReferenceCitation: Zhang X, Goel V, Attarwala H, Sweetser MT, Clausen VA, Robbie GJ. Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis. J Clin Pharmacol. 2020 Jan;60(1):37-49. doi: 10.1002/jcph.1480. Epub 2019 Jul 19.

ReferenceCitation: Minamisawa M, Claggett B, Adams D, Kristen AV, Merlini G, Slama MS, Dispenzieri A, Shah AM, Falk RH, Karsten V, Sweetser MT, Chen J, Riese R, Vest J, Solomon SD. Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study. JAMA Cardiol. 2019 May 1;4(5):466-472. doi: 10.1001/jamacardio.2019.0849.

ReferenceCitation: Solomon SD, Adams D, Kristen A, Grogan M, González-Duarte A, Maurer MS, Merlini G, Damy T, Slama MS, Brannagan TH 3rd, Dispenzieri A, Berk JL, Shah AM, Garg P, Vaishnaw A, Karsten V, Chen J, Gollob J, Vest J, Suhr O. Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis. Circulation. 2019 Jan 22;139(4):431-443. doi: 10.1161/CIRCULATIONAHA.118.035831.

ReferenceCitation: Adams D, Gonzalez-Duarte A, O'Riordan WD, Yang CC, Ueda M, Kristen AV, Tournev I, Schmidt HH, Coelho T, Berk JL, Lin KP, Vita G, Attarian S, Planté-Bordeneuve V, Mezei MM, Campistol JM, Buades J, Brannagan TH 3rd, Kim BJ, Oh J, Parman Y, Sekijima Y, Hawkins PN, Solomon SD, Polydefkis M, Dyck PJ, Gandhi PJ, Goyal S, Chen J, Strahs AL, Nochur SV, Sweetser MT, Garg PP, Vaishnaw AK, Gollob JA, Suhr OB. Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):11-21. doi: 10.1056/NEJMoa1716153.

ReferenceCitation: Adams D, Suhr OB, Dyck PJ, Litchy WJ, Leahy RG, Chen J, Gollob J, Coelho T. Trial design and rationale for APOLLO, a Phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy. BMC Neurol. 2017 Sep 11;17(1):181. doi: 10.1186/s12883-017-0948-5.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Japan
Portugal
Australia
Argentina
Turkey
Mexico
Sweden
Malaysia
Cyprus
Brazil
Canada
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Netherlands


title: A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)

acronym: SALT

summary: The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

ipd_sharing: No

location_country: Denmark Portugal Austria Netherlands Switzerland Sweden France Belgium Norway Germany


acronym: TRANSFORM

title: A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

ReferenceCitation: Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.

ReferenceCitation: Watarai Y, Danguilan R, Casasola C, Chang SS, Ruangkanchanasetr P, Kee T, Wong HS, Kenmochi T, Amante AJ, Shu KH, Ingsathit A, Bernhardt P, Hernandez-Gutierrez MP, Han DJ, Kim MS. Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study. Clin Transplant. 2021 Oct;35(10):e14415. doi: 10.1111/ctr.14415. Epub 2021 Sep 23.

ReferenceCitation: Citterio F, Henry M, Kim DY, Kim MS, Han DJ, Kenmochi T, Mor E, Tisone G, Bernhardt P, Hernandez Gutierrez MP, Watarai Y. Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study. Expert Opin Drug Saf. 2020 Oct;19(10):1339-1348. doi: 10.1080/14740338.2020.1792441. Epub 2020 Jul 20.

ReferenceCitation: Berger SP, Sommerer C, Witzke O, Tedesco H, Chadban S, Mulgaonkar S, Qazi Y, de Fijter JW, Oppenheimer F, Cruzado JM, Watarai Y, Massari P, Legendre C, Citterio F, Henry M, Srinivas TR, Vincenti F, Gutierrez MPH, Marti AM, Bernhardt P, Pascual J; TRANSFORM investigators. Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study. Am J Transplant. 2019 Nov;19(11):3018-3034. doi: 10.1111/ajt.15480. Epub 2019 Jul 1.

ReferenceCitation: Pascual J, Berger SP, Witzke O, Tedesco H, Mulgaonkar S, Qazi Y, Chadban S, Oppenheimer F, Sommerer C, Oberbauer R, Watarai Y, Legendre C, Citterio F, Henry M, Srinivas TR, Luo WL, Marti A, Bernhardt P, Vincenti F; TRANSFORM Investigators. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation. J Am Soc Nephrol. 2018 Jul;29(7):1979-1991. doi: 10.1681/ASN.2018010009. Epub 2018 May 11.

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

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United States
Belgium
Japan
Philippines
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Egypt
Kuwait
Brazil
Lebanon
Switzerland
Germany
Bulgaria
Taiwan
Greece
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

summary: This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.


title: A Randomized, Double-blind, Parallel-arm, Phase I Study to Evaluate the Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab (MabThera) Induction Immunotherapy as a First-line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

summary:
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL).

The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

lead_sponsor: Boehringer Ingelheim

location_country:
Croatia
Poland
Spain
Greece
Austria
Australia
New Zealand
Russian Federation
Hungary
France
Belgium
Germany
Czechia

location_facility: St. Petersburg GUZ City Clinical Oncology Dispensary

location_facility: BHI of Omsk region - Clinical Oncology Dispensary

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Semmelweis University, 1st Dept. Internal Medicine

location_facility: Centre Hospitalier Départemental Les Oudairies


title: ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment

acronym: ASPIRE

summary: This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.

ReferenceCitation: Esquenazi A, Francisco GE, Feng W, Baricich A, Gallien P, Fanning K, Zuzek A, Bandari DS, Wittenberg GF. Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2172-2184.e6. doi: 10.1016/j.apmr.2021.06.008. Epub 2021 Jul 7.

ReferenceCitation: Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11.

ReferenceCitation: Francisco GE, Jost WH, Bavikatte G, Bandari DS, Tang SFT, Munin MC, Largent J, Adams AM, Zuzek A, Esquenazi A. Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study. PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27.

lead_sponsor: Allergan

location_country:
Taiwan
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: Hospital de Conxo (Santiago de Compostela) GALICIA

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Dayton Center for Neurological Disorders

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Loma Linda University School Of Medicine

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Albert Einstein Healthcare Network, Moss Rehabilitation Hospital

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care

location_facility: Nottingham University Hospitals City Campus

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Michigan Institute for Neurological Disorders


title: REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

acronym: REDUCE LAP-HF

summary: The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

ReferenceType: background

ReferenceCitation: Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hünlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.

ReferenceType: result

ReferenceCitation: Hasenfuß G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.

ReferenceCitation: Kaye DM, Hasenfuß G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12). pii: e003662.

ReferenceCitation: Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.

ReferenceCitation: Kaye DM, Petrie MC, McKenzie S, Hasenfuβ G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.

ReferenceCitation: Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfuβ G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.

ReferenceCitation: Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfuβ G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.

ReferenceCitation: Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfuβ G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.

lead_sponsor: Corvia Medical

location_country:
Denmark
Poland
United Kingdom
Austria
Australia
Netherlands
New Zealand
France
Belgium
Germany
Czechia

location_facility: Allgemeines Krankenhaus Univesitäts Kliniken

intervention_type: Device


title: A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib (Velcade) in Patients With Multiple Myeloma in First or Second Relapse.

acronym: OPTIMRETREAT

summary: The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on progression free survival (PFS).

ReferenceCitation: Terpos E, Gobbi M, Potamianou A, Lahaye M, Couturier C, Cavo M. Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study. Eur J Haematol. 2018 Jan;100(1):10-19. doi: 10.1111/ejh.12937. Epub 2017 Oct 30.

lead_sponsor: Janssen-Cilag International NV

location_country: Poland Portugal Netherlands Finland Sweden France Israel Turkey Belgium Norway Germany


title: A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Platinum Failure

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

ReferenceCitation: Fehlings M, Jhunjhunwala S, Kowanetz M, O'Gorman WE, Hegde PS, Sumatoh H, Lee BH, Nardin A, Becht E, Flynn S, Ballinger M, Newell EW, Yadav M. Late-differentiated effector neoantigen-specific CD8+ T cells are enriched in peripheral blood of non-small cell lung carcinoma patients responding to atezolizumab treatment. J Immunother Cancer. 2019 Sep 12;7(1):249. doi: 10.1186/s40425-019-0695-9.

ReferenceCitation: Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10.

location_country:
Poland
Spain
Italy
United Kingdom
Canada
Thailand
Sweden
Korea, Republic of
United States
France
Turkey
Belgium
Germany

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Citta Ospedaliera; Divisione Oncologia Medica

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Providence St. Mary Regional Cancer Center

location_facility: National Cancer Center; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie

location_facility: Rocky Mountain Cancer Centers - Colorado Springs (Circle)

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

summary: This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


title: AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, García-Gutiérrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brümmendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

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

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
South Africa
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Turkey
Singapore
Brazil
Canada
Hungary
China
Latvia
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: State Institution "National Research Center for Radiation Medicine of the National Academy of

location_facility: State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin

location_facility: Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara Campal

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: State Budgetary Institution of Rostov Region - Rostov Regional Clinical Hospital

location_facility: Sir Mortimer B. Davis-Jewish General Hospital

location_facility: Helsingin Yliopistollinen Keskussairaala, Hematologian poliklinikka

location_facility: State Institution "Institute of Blood Pathology and Transfusion Medicine of

location_facility: Department of Medicine & Therapeutics, Prince of Wales Hospital

location_facility: State Budgetary Educational Institution of Higher Professional Education

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: State Budgetary Institution of Healthcare - Leningrad Regional Clinical Hospital

location_facility: Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College

location_facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine

location_facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi

location_facility: Federal State-Funded Institution National Research Center of Hematology of the Ministry of

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Hudson Valley Hematology and Oncology Associates

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Wits Clinical Research-Chris Hani Baragwanath Hospital

location_facility: Unidad de Investigacion de Hematologia - Hospital Nacional Edgardo Rebagliati Martins

location_facility: Northside Hospital, Inc. - Central Research Department

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: University Medical Center Groningen, Department of Hematology

location_facility: State Budgetary Institution of Healthcare of Sverdlovsk Region

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

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Hospital Clinico Universitario De Valencia (CHUV)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,

location_facility: Indiana Blood and Marrow Transplantation

location_facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" of DRC Hematology Center

location_facility: Clinic "Institute of Pediatric Oncology, Hematology and Transplantation n.a. R.M. Gorbachova"

location_facility: The First affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Municipal Institution "Cherkasy Regional Oncology Dispensary"

location_facility: Universidade Estadual de Campinas / Centro de Hematologia e Hemoterapia

location_facility: Federal State Budgetary Institution "Federal Almazov Medical Research Centre"

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Strasbourg Oncologie Liberale -Centre de Radiotherapie, Clinique Ste Anne

location_facility: Kyiv City Clinical Hospital #9, SI "Institute of Hematology and Transfusiology of NAMS of Ukraine"

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Alberta Health Services - Department of Medical Oncology - Cross Cancer Institute

location_facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa em Hematologia e Oncologia (CEPHO)

location_facility: Northside Hospital Inc., - GCS/Northside

summary: The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.


title: A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

summary: To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Deiva K, Huppke P, Banwell B, Chitnis T, Gärtner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.

ReferenceCitation: Chitnis T, Arnold DL, Banwell B, Brück W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostásy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gärtner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Poland
Austria
Australia
Russian Federation
Puerto Rico
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Germany
Bulgaria
Belarus
Latvia
Estonia
France
Netherlands


title: A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

summary: Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.

ReferenceCitation: Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11. Erratum in: J Clin Oncol. 2019 Jun 1;37(16):1448.

lead_sponsor: SecuraBio

location_country:
Belarus
Spain
Italy
Georgia
United Kingdom
Canada
Hungary
United States
France
Belgium
Bulgaria
Czechia


acronym: VERIFY

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA™; SAR390530 (Formerly AstraZeneca ZD6474)) 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Denmark
Poland
Brazil
Spain
Italy
Russian Federation
United States
France
China
Japan
Sweden
Czechia

location_facility:
Washington University
Research Site

summary:
Primary Objective:

To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy.

Secondary Objectives:

To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS).
To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK.
To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population.
To evaluate the safety and tolerability of vandetanib treatment in this participant population.


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

acronym: ARTS-DN

summary: To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

ReferenceCitation: Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

ReferenceCitation: Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

ReferenceCitation: Erraez S, López-Mesa M, Gómez-Fernández P. [Mineralcorticoid receptor blockers in chronic kidney disease]. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. Review. English, Spanish.

location_country:
Spain
Italy
United States
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Israel
Norway
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Mexico
Canada
United States
France
Peru
Belgium
Japan
Germany

location_facility: Southampton General Hospital; Respiratory Department

location_facility: University Vermont College Medicine Fletcher Allen Health Care

location_facility: Respiratory research department clinical science building

location_facility: Hospital Clínico San Carlos - Servicio de Neumologia

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Hospital General Universitario De Valencia; Servicio de Neumologia

location_facility: Weill Medical College of Cornell University

location_facility: Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare

location_facility: Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: St James University Hospital; Respiratory Department

location_facility: Papworth Hospital NHS Foundation Trust; Respiratory Department

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Neumologia

location_facility: North Manchester Hospital; Respiratory Department

location_facility: CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum

location_facility: Southern Arizona Veterans Administration Healthcare Systems

location_facility: A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone

location_facility: Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center

location_facility: Rocky Mountain Center For Clinical Research

location_facility: Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: Mt Sinai School Medical Pulmo And Critical Care Med

location_facility: Royal Prince Alfred Hospital; Department of Respiratory Medicine

location_facility: Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny

location_facility: University Wisconsin Hospitals and Clinics

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: University of Utah Health Sciences Center, Lung Health Research Center

location_facility: Ospedale Morgagni-Pierantoni; U.O. Pneumologia

location_facility: Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)

location_facility: Hospital Universitario La Princesa; Servicio de Neumologia

location_facility: Case Western Research University; University Hospitals Case Medical Center

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Oklahoma University Health Sciences Center

location_facility: Highland Hospital-University of Rochester Medical Center

location_facility: Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Hospital Universitari de Bellvitge ; Servicio de Neumologia

location_facility: Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone

location_facility: ST VINCENT'S HOSPITAL; Thoracic Medicine

location_facility: University of Minnesota Hospital & Clinic

location_facility: Southmead Hospital; Respiratory Department

location_facility: Maine Medical Center -Division of Pulmomary and Critical Care Medicine

location_facility: University of Chicago; Pulmonary and Critical Care

location_facility: Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute

location_facility: University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease

location_facility: Penn State University College Medical Allergy And Care Med

location_facility: Inova Transplant Center Fairfax Hospital

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Cardiopulmonary Associates LLC Cardiopulmonary Research

location_facility: Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.


title: MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction

acronym: MASTER-II

summary: To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.

status: Terminated

lead_sponsor: InspireMD

location_country:
Poland
Spain
United Kingdom
Estonia
Netherlands
Finland
Czech Republic
United States
France
Israel
Belgium
Germany

location_facility: Cardiology Associates of North Mississippi

location_facility: Charité Universitätsklinikum Berlin Campus Virchow

location_facility: University Hospitals Southampton NHS Foundation Trust

location_facility: Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi

location_facility: Hospital Clinic, University of Barcelona

location_facility: MedStar Southern Maryland Hospital Center

location_facility: Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: Krakowskie Centrum Kardiologii Inwazyjnej

location_facility: University Hospitals Case Medical Center

location_facility: Charité Universitätsklinikum Berlin Campus Benjamin Franklin

location_facility: Hospital Universitario Madrid Montepríncipe

status_simplified: Unknown


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

ReferenceCitation: Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

ReferenceCitation: N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.

ReferenceCitation: Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

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

location_facility: Central Clinical Hospital #1 of RZhD JCS

location_facility: Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi

location_facility: Kirikkale Universitesi Tip Fakultesi Hastanesi

location_facility: Allergy & Asthma Care of FL; Clinical Research

location_facility: St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department

location_facility: St-Petersburg Diagnostic Ctr#1; Pulmonology

location_facility: Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi

location_facility: SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia

location_facility: Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC

location_facility: National Hospital Organization Mito Medical Center

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

location_facility: Florida Pulmonary Research Institute, LLC

location_facility: Central Outpatient Hospital of Desnyansky District

location_facility: Central PA Asth & Allergy Care; Research Division

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Clinical Research Inst. of Southern Oregon, Pc

location_facility: Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional

location_facility: Municipal Institution of Health Care "Yevpatoriya City Hospital №1

location_facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

location_facility: St James University Hospital; Respiratory Department

location_facility: Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.

location_facility: Danylo Halytskyy National Medical University; Lviv

location_facility: Small Business Private Enterprise Medical Centre Pulse

location_facility: Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

location_facility: Castle Hill Hospital; Respiratory Medicine

location_facility: Prof.Dr.Octavian Fodor Emergency Clinical Hospital

location_facility: Ninewells Hospital; Asthma and Allergy Research Group

location_facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

location_facility: St. Francis Sleep; Allergy & Lung Institute

location_facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie

location_facility: Centro de Investigaciones Medicas Respiratorias

location_facility: Specjalistyczne Centrum Medyczne NOWOMED

location_facility: Laporte County Institute For Clinical Research

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital

location_facility: Allergy & Asthma Medical Group & Research Center, Pc

location_facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

location_facility: Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

location_facility: Northeast Medical Research Associates, Inc

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

location_facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology

location_facility: Barzilai Medical Center; Pulmonary Inst.

location_facility: Uludag University; Pulmonology and Allergy Department

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: Educational Scientific Medical Centre of Donetsk National Medical University;

location_facility: Centrum Medycyny Oddechowej Robert M. Mróz

location_facility: Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: Dokkyo Medical University Koshigaya Hospital

location_facility: Regional Phthisiology and Pulmonology Center

location_facility: Seoul National University Bundang Hospital

location_facility: A.o. Universitaria Pisana; Dipartimento Cardio Toracico

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Grand View Hospital; Clinical Research Department

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centre d'investigation Clinique Mauricie

location_facility: St. Paul's Hospital, The Catholic University of Korea, College of Medicine

location_facility: Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy

location_facility: Allergy & Asthma Diagnostic; Treatment Center

location_facility: Allergy & Asthma Research Center of El Paso

location_facility: Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.

location_facility: Tosei General Hospital; Respiratory and Allergy Medicine

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

location_facility: Lady Davis Carmel Medical Center; Cardiovascular Medicine

location_facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

location_facility: Grazyna Pulka Specjalistyczny Ośrodek ALL-MED


acronym: DIMENSION

title: Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV

design_allocation: Non-Randomized

ReferenceCitation: Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.

location_country:
Poland
Spain
Italy
Russian Federation
Mexico
United Kingdom
Argentina
Canada
United States
France
Belgium
Germany

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Vancouver Id Reserach & Care Centre Society

location_facility: Mcgill University Health Centre (Muhc) Montreal Chest Institute

summary: To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1


acronym: ASTRAEA

title: A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis

ReferenceCitation: McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial. RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.

ReferenceCitation: Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ. Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial. Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.

ReferenceCitation: Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.

location_country:
Poland
Brazil
Spain
Greece
Italy
Mexico
Argentina
Canada
United States
Chile
France
Israel
Colombia
Peru
Germany
South Africa
Czechia

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Groupe De Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Clinical Research Center Of Reading, Llc

location_facility: Arthritis Asso & Osteo Ctr Of Colorado Springs

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Toronto Western Hospital, University Health Network

summary: The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis


title: A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

ReferenceCitation: Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

ReferenceCitation: Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penades I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept. Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.

ReferenceCitation: Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Berman A, Calvo Penadés I, Antón J, Ávila-Zapata F, Cuttica R, Horneff G, Foeldvari I, Keltsev V, Kingsbury DJ, Viola DO, Joos R, Lauwerys B, Paz Gastañaga ME, Rama ME, Wouters C, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Miraval T, Ally MMTM, Rubio-Pérez N, Solau Gervais E, van Zyl R, Li X, Nys M, Wong R, Banerjee S, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: Results From a Phase III Open-Label Study. Arthritis Rheumatol. 2018 Jul;70(7):1144-1154. doi: 10.1002/art.40466. Epub 2018 May 20.

location_country:
Brazil
Spain
Italy
Russian Federation
Mexico
Argentina
France
United States
Peru
South Africa
Belgium
Germany

location_facility:
Local Institution - 0037
Local Institution - 0047
Local Institution - 0022
Local Institution - 0068
Local Institution - 0036
Local Institution - 0056
Local Institution - 0027
Local Institution - 0011
Local Institution - 0057
Local Institution - 0061
Local Institution - 0040
Local Institution - 0059
Local Institution - 0062
Local Institution - 0005
Local Institution - 0029
Local Institution - 0048
Local Institution - 0033
Local Institution - 0015
Local Institution - 0025
Local Institution - 0003
Local Institution - 0018
Local Institution - 0042
Local Institution - 0030
Local Institution - 0038
Local Institution - 0026
Local Institution - 0016
Local Institution - 0034
Local Institution - 0053
Local Institution - 0028
Local Institution - 0001
Local Institution - 0060
Riley Hospital For Children
Local Institution - 0031
Local Institution - 0041
Local Institution - 0052
Local Institution - 0064
Local Institution - 0035
Local Institution
Local Institution - 0050
Local Institution - 0046
Local Institution - 0007
University Of Kansas Medical Center
Local Institution - 0002
Local Institution - 0045
Local Institution - 0058
Local Institution - 0014
Local Institution - 0009
Local Institution - 0004
Local Institution - 0044
Local Institution - 0008
Local Institution - 0032
Seattle Children'S Hospital
Local Institution - 0017
Local Institution - 0049

summary: The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA