acronym: BRIGHT

lead_sponsor: Sanofi

summary:
Primary Objective:

To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.

Secondary Objectives:

Change From Baseline in HbA1c to Week 12

To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:

Change in Fasting plasma glucose (FPG);
Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
Percentage of participants reaching HbA1c targets <7% or ≤6.5%;
Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia
Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.

To assess the safety in each treatment group.

To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).

Percentage of participants requiring rescue therapy.

ReferenceCitation: Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frias JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13.

publisher_dissemination: American Diabetes Association

location_facility:
Investigational Site Number 840065
Investigational Site Number 191002
Investigational Site Number 380010
Investigational Site Number 840012
Investigational Site Number 376007
Investigational Site Number 100003
Investigational Site Number 688001
Investigational Site Number 688003
Investigational Site Number 703002
Investigational Site Number 840080
Investigational Site Number 840029
Investigational Site Number 203008
Investigational Site Number 840098
Investigational Site Number 840075
Investigational Site Number 840070
Investigational Site Number 840066
Investigational Site Number 642003
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Investigational Site Number 703006
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Investigational Site Number 642006
Investigational Site Number 203002
Investigational Site Number 642009
Investigational Site Number 300005
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Investigational Site Number 840036
Investigational Site Number 840020
Investigational Site Number 376009
Investigational Site Number 840101
Investigational Site Number 300003
Investigational Site Number 380011
Investigational Site Number 208001
Investigational Site Number 380007
Investigational Site Number 348001
Investigational Site Number 250007
Investigational Site Number 250002
Investigational Site Number 756003
Investigational Site Number 348003
Investigational Site Number 756001
Investigational Site Number 642015
Investigational Site Number 840051
Investigational Site Number 840002
Investigational Site Number 208002
Investigational Site Number 840001
Investigational Site Number 840023
Investigational Site Number 203005
Investigational Site Number 826004
Investigational Site Number 840039
Investigational Site Number 840025
Investigational Site Number 840091
Investigational Site Number 380008
Investigational Site Number 840040
Investigational Site Number 840043
Investigational Site Number 703005
Investigational Site Number 380016
Investigational Site Number 688002
Investigational Site Number 380012
Investigational Site Number 376006
Investigational Site Number 703001
Investigational Site Number 191001
Investigational Site Number 840060
Investigational Site Number 840054
Investigational Site Number 642007
Investigational Site Number 840017
Investigational Site Number 840072
Investigational Site Number 840024
Investigational Site Number 380014
Investigational Site Number 752102
Investigational Site Number 642013
Investigational Site Number 300002
Investigational Site Number 840021
Investigational Site Number 840041
Investigational Site Number 840069
Investigational Site Number 203007
Investigational Site Number 642001
Investigational Site Number 840044
Investigational Site Number 100002
Investigational Site Number 208004
Investigational Site Number 642012
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Investigational Site Number 208003
Investigational Site Number 380009
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 100001
Investigational Site Number 203004
Investigational Site Number 376001
Investigational Site Number 840030
Investigational Site Number 376008
Investigational Site Number 203006
Investigational Site Number 840085
Investigational Site Number 840032
Investigational Site Number 840022
Investigational Site Number 840048
Investigational Site Number 642005
Investigational Site Number 250005
Investigational Site Number 840096
Investigational Site Number 348004
Investigational Site Number 826009
Investigational Site Number 642004
Investigational Site Number 376002
Investigational Site Number 840087
Investigational Site Number 840006
Investigational Site Number 840088
Investigational Site Number 380013
Investigational Site Number 376003
Investigational Site Number 840046
Investigational Site Number 840057
Investigational Site Number 840076
Investigational Site Number 840033
Investigational Site Number 191003
Investigational Site Number 703003
Investigational Site Number 840045
Investigational Site Number 840077
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840053
Investigational Site Number 380005
Investigational Site Number 840004
Investigational Site Number 380015
Investigational Site Number 826005
Investigational Site Number 840016
Investigational Site Number 826001
Investigational Site Number 826008
Investigational Site Number 300001
Investigational Site Number 840097
Investigational Site Number 203001
Investigational Site Number 203009
Investigational Site Number 840093
Investigational Site Number 840081
Investigational Site Number 250006
Investigational Site Number 642008
Investigational Site Number 840094
Investigational Site Number 840007
Investigational Site Number 840058
Investigational Site Number 250001
Investigational Site Number 348002
Investigational Site Number 752101
Investigational Site Number 826006
Investigational Site Number 826002
Investigational Site Number 840031
Investigational Site Number 840084
Investigational Site Number 840056
Investigational Site Number 840063
Investigational Site Number 840027
Investigational Site Number 840071
Investigational Site Number 840086
Investigational Site Number 376004
Investigational Site Number 840095
Investigational Site Number 840061
Investigational Site Number 840052
Investigational Site Number 840010
Investigational Site Number 642010
Investigational Site Number 642014
Investigational Site Number 840079
Investigational Site Number 380002
Investigational Site Number 840011
Investigational Site Number 840005

title: A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

location_country:
Italy
Slovakia
Hungary
Israel
Denmark
Romania
Sweden
Switzerland
United Kingdom
United States
Greece
Croatia
Czechia
Bulgaria
Serbia
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: GlaxoSmithKline

summary: This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.

ReferenceType: background

ReferenceCitation: Bremner PR, Birk R, Brealey N, Ismaila AS, Zhu CQ, Lipson DA. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study. Respir Res. 2018 Jan 25;19(1):19. doi: 10.1186/s12931-018-0724-0.

ReferenceType: derived

ReferenceCitation: Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

status: Completed

title: A Phase IIIB, 24-week Randomised, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI) With 'Open' Triple Therapy (FF/VI + UMEC), in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Argentina
Romania
Australia
Japan
Mexico
Korea, Republic of
Spain
Russian Federation
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


acronym: MAXIMISE

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

ReferenceCitation: Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

evidence: open (via page says license)

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

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central
ora.ox.ac.uk

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

publisher_dissemination: British Medical Journal

title: MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

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

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

location_country:
Finland
Germany
Ireland
Italy
Poland
Hungary
Israel
Romania
United Kingdom
Switzerland
Belgium
Spain
Greece
Czechia
Bulgaria
Estonia
Russian Federation
France

ipd_sharing: Undecided


acronym: COAST-W

lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

ReferenceCitation: van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

license: cc-by

license_normalized: cc-by

repository_institution: Radboud University - Radboud Repository

repositories:
LIRIAS (KU Leuven)
PubMed Central
repository.ubn.ru.nl

repositories_concat: LIRIAS (KU Leuven);PubMed Central;repository.ubn.ru.nl

repositories_institution:
KU Leuven - Lirias
Radboud University - Radboud Repository

ReferenceCitation: Maksymowych WP, Bolce R, Gallo G, Seem E, Geneus VJ, Sandoval DM, Ostergaard M, Tada K, Baraliakos X, Deodhar A, Gensler LS. Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging. Rheumatology (Oxford). 2022 Nov 2;61(11):4324-4334. doi: 10.1093/rheumatology/keac104.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

ReferenceCitation: van der Heijde D, Ostergaard M, Reveille JD, Baraliakos X, Kronbergs A, Sandoval DM, Li X, Carlier H, Adams DH, Maksymowych WP. Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years. J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Deodhar AA, Mease PJ, Rahman P, Navarro-Compan V, Strand V, Hunter T, Bolce R, Leon L, Lauzon S, Marzo-Ortega H. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021 Sep 20;5(1):35. doi: 10.1186/s41927-021-00205-3.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

ReferenceCitation: Dougados M, Wei JC, Landewe R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4. Erratum In: Ann Rheum Dis. 2020 Jun;79(6):e75.

repository_institution: Ghent University - Ghent University Academic Bibliography

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

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Jarvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repository_institution: University of East Anglia - UEA Digital Repository

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

location_facility: St Luke's Clinic - Intermountain Orthopaedics

location_facility: Center for Arthritis and Rheumatic Diseases, PC

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

location_facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

location_facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

location_facility: Univ of Texas Health Science Center - Houston

title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis

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

location_country:
Finland
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Japan
Brazil
Netherlands
Mexico
United States
Korea, Republic of
Spain
Canada
Puerto Rico
France


type: Other Identifier

title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

status: Terminated

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

lead_sponsor: Pfizer

location_country:
Germany
Japan
United States
Spain
Canada
France

location_facility: Montreal Neurological Hospital Research Pharmacy

location_facility: Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute

location_facility: Indiana University Health Neuroscience Center

location_facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine

location_facility: Tazuke Kofukai Medical Research Institute Kitano Hospital

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Duke University/Duke Neurology/Department of Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie

location_facility: AS Clinical Research Consultants of North Texas, PLLC

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Medical Corporation Abe Neurology Clinic

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Vero Beach Neurology and Research Institute

location_facility: Hospital Universitario y Politecnico la Fe

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Associated Neurologists of Southern Connecticut, PC

location_facility: Rhode Island Hospital/ Brown University Medical School

status_simplified: Unknown


summary: The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)

ReferenceCitation: Shahid S, Kushner BH, Modak S, Basu EM, Rubin EM, Gundem G, Papaemmanuil E, Roberts SS. Association of BRAF V600E mutations with vasoactive intestinal peptide syndrome in MYCN-amplified neuroblastoma. Pediatr Blood Cancer. 2021 Oct;68(10):e29265. doi: 10.1002/pbc.29265. Epub 2021 Jul 31.

version: acceptedVersion

publisher_dissemination: Wiley

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago .

location_facility: Washington University School of Medicine SC

location_facility: Johns Hopkins University IDS Pharmacy John Hopkins Hospital

location_facility: Texas Children s Hospital Baylor College of Medicine

location_facility: Cincinnati Childrens Hospital Medical Center Cancer & Blood Disease Inst.

title: Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Spain
Russian Federation
Israel


title: A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease

summary: The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

ipd_sharing: No

lead_sponsor: Shield Therapeutics

location_country:
Germany
Hungary
Belgium
United States
Spain
France


title: Sorin Universal REgistry on Aortic Valve Replacement

acronym: SURE-AVR

summary:
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.

5,000 patients to be enrolled approximately worldwide.

The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Corcym S.r.l

location_country:
Germany
Italy
Slovakia
Israel
Singapore
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Bulgaria
Canada
France

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: Center of Cardiovascular Surgery and Transplantation Brno

location_facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

location_facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine

location_facility: Foothill Medical Centre - Calgary, Alberta

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: Baylor Scott and White Research Institute


title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus

summary:
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response.

The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

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

ReferenceCitation: Houssiau FA, Thanou A, Mazur M, Ramiterre E, Gomez Mora DA, Misterska-Skora M, Perich-Campos RA, Smakotina SA, Cerpa Cruz S, Louzir B, Croughs T, Tee ML. IFN-alpha kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. 2020 Mar;79(3):347-355. doi: 10.1136/annrheumdis-2019-216379. Epub 2019 Dec 23.

oa_host_type: closed

lead_sponsor: Neovacs

location_country:
Germany
Poland
Argentina
Thailand
Croatia
Chile
France
Colombia
Switzerland
United States
Tunisia
Belgium
Peru
Moldova, Republic of
Philippines
Italy
Mexico
Korea, Republic of
Taiwan
Georgia
Russian Federation

location_facility:
Research site
Research Site

intervention_type: Other


title: An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

summary: The primary purpose of the study is to evaluate objective response rate ([ORR]: complete response [CR] and partial response [PR]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.

ReferenceCitation: Wirth LJ, Brose MS, Sherman EJ, Licitra L, Schlumberger M, Sherman SI, Bible KC, Robinson B, Rodien P, Godbert Y, De La Fouchardiere C, Newbold K, Nutting C, Misir S, Xie R, Almonte A, Ye W, Cabanillas ME. Open-Label, Single-Arm, Multicenter, Phase II Trial of Lenvatinib for the Treatment of Patients With Anaplastic Thyroid Cancer. J Clin Oncol. 2021 Jul 20;39(21):2359-2366. doi: 10.1200/JCO.20.03093. Epub 2021 May 7.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_dissemination: Elsevier

ipd_sharing_description: Eisai IPD sharing statement: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
Italy
United Kingdom
Australia
United States
France


title: A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

summary:
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.

The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Saenger P, Horikawa R. Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1357-1367. doi: 10.1210/clinem/dgab928.

publisher_dissemination: The Endocrine Society

ReferenceCitation: Savendahl L, Battelino T, Brod M, Hojby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1847-61. doi: 10.1210/clinem/dgz310. Erratum In: J Clin Endocrinol Metab. 2020 Dec 1;105(12):

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Slovenia
India
Israel
Japan
Brazil
Sweden
Austria
Belgium
United States
Turkey
Ukraine
France

status_simplified: Ongoing


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

ReferenceType: result

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

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

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

repositories:
2f75rf68h
PubMed Central
RePEc

repositories_concat: 2f75rf68h;PubMed Central;RePEc

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

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

oa_colors: green other

publisher_dissemination: American Society for Microbiology

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

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

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

ReferenceCitation: Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

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

licence_repositories: cc-by-nc-nd cc-by-nc-sa

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Indiana University - IUScholarWorks

version: submittedVersion

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

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

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

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

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

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

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

evidence: open (via free article)

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

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

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

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

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

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

location_facility: Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Wake Forest Baptist Medical Center - PPDS

location_facility: Instituto Dominicano de Estudios Virologicos IDEV

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Infectious Disease Specialists of Atlanta

location_facility: North Texas Infectious Diseases Consultants PA

location_facility: Louisiana State University Health Sciences Center

location_facility: The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research

location_facility: Multicare Rockwood HIV Critical Care Clinic

location_facility: North Shore University Hospital-(Manhasset)

location_facility: Alameda Health System- Highland Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Diagnostic Clinic of Longview Center For Clinical Research (DCOL)

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

location_facility: Medical University of South Carolina PPDS

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: North Manchester General Hospital - PPDS

location_facility: Southampton Clinical Research Group, Inc.

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

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

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


title: A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3

summary: The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country: Canada France


lead_sponsor: Hoffmann-La Roche

summary: This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

ReferenceCitation: Furie RA, Aroca G, Cascino MD, Garg JP, Rovin BH, Alvarez A, Fragoso-Loyo H, Zuta-Santillan E, Schindler T, Brunetta P, Looney CM, Hassan I, Malvar A. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-107. doi: 10.1136/annrheumdis-2021-220920. Epub 2021 Oct 6.

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.

location_facility: Centro de Investigación Clínica de Morelia S.C.

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

location_facility: Hospital Nacional Cayetano Heredia; Rheumatology

location_facility: Centro de Investigación Delgado; Clinica Delgado

location_facility: Suny Downstate Medical Center; Rheumatology

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Ospedale San Giovanni Bosco; entro di Ricerche di Immunopatologia e Documentazione su Malattie Rare

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

location_facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

location_facility: Hopital europeen Marseille; Service de medecine interne

location_facility: Ohio State University; Division of Nephrology

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia

location_facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology

location_facility: Hospital General De Mexico; Rheumatology

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia

location_facility: Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii

location_facility: Hopital Bichat Claude Bernard; Nephrologie

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
Colombia
Israel
Argentina
Brazil
Costa Rica
Mexico
United States
Spain
Panama
Peru
France


title: An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in Patients With Muscle Invasive Bladder Cancer (MIBC) Who Have Progressed on Prior Treatment (BISCAY).

acronym: BISCAY

summary:
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents.

The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination.

status: Active, not recruiting

ReferenceCitation: Powles T, Carroll D, Chowdhury S, Gravis G, Joly F, Carles J, Flechon A, Maroto P, Petrylak D, Rolland F, Cook N, Balar AV, Sridhar SS, Galsky MD, Grivas P, Ravaud A, Jones R, Cosaert J, Hodgson D, Kozarewa I, Mather R, McEwen R, Mercier F, Landers D. An adaptive, biomarker-directed platform study of durvalumab in combination with targeted therapies in advanced urothelial cancer. Nat Med. 2021 May;27(5):793-801. doi: 10.1038/s41591-021-01317-6. Epub 2021 May 3.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

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:
United Kingdom
United States
Spain
Canada
France


summary: The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.

ReferenceCitation: Shah MA, Bodoky G, Starodub A, Cunningham D, Yip D, Wainberg ZA, Bendell J, Thai D, He J, Bhargava P, Ajani JA. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol. 2021 Mar 20;39(9):990-1000. doi: 10.1200/JCO.20.02755. Epub 2021 Feb 12.

location_facility: Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust

location_facility: Klinikum rechts der Isar Technical University of Ismaninger

location_facility: Ankara University Medical Faculty Ibni Sina Hospital

location_facility: Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali

location_facility: Izmir Universitesi Hastanesi Yeni Girne Vulvari

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Zentrum fur Innere Medizin Stauferklinikum Schwab

location_facility: S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio

location_facility: Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica

location_facility: University Hospital Gent Department of Gastroenterology

location_facility: CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie

location_facility: SC Centrul de Oncologie Euroclinic SRL, Oncologie

location_facility: Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi Elazi

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Egyesített Szent István és Szent László Kórház -Rendelőintézet

location_facility: Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul

location_facility: Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut

location_facility: Charleston Hematology Oncology Associates

location_facility: Hospital Regional Universitario de Malaga

location_facility: Indiana University Goshen Center for Cancer Care

location_facility: Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal

location_facility: Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

location_facility: Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung

location_facility: Cancer Center Heilbronn-Franken, SLK-Kliniken

location_facility: Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie

location_facility: DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie

location_facility: Clinica Anglo Americana Calle Alfredo Salazar

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK

location_facility: Regional Cancer Care Associates LLC - Sparta

location_facility: Staedtisches Klinikum Muenchen Bogenhausen

location_facility: Centrul de Oncologie Sfantul Nectarie SRL, Oncologie

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II

location_facility: Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali

location_facility: Borsod County Hospital Clinical Oncological and Radiotheraputic Center

location_facility: Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny

location_facility: Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

location_country:
Germany
Italy
Poland
Colombia
Hungary
United Kingdom
Romania
Australia
Belgium
United States
Spain
Turkey
Chile
Czechia
Peru
France


title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).

summary: To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Germany
Italy
Lithuania
Poland
Portugal
Slovakia
Hungary
United Kingdom
Switzerland
Austria
Spain
Czechia
Canada
France


title: An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma

summary:
Primary Objective:

Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM).
Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab.

Secondary Objectives:

Part A:
To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.
Part B:
To evaluate the safety of SAR650984 (isatuximab).
To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS).
To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline.
To evaluate the immunogenicity of SAR650984 (isatuximab).

ReferenceCitation: Mikhael J, Belhadj-Merzoug K, Hulin C, Vincent L, Moreau P, Gasparetto C, Pour L, Spicka I, Vij R, Zonder J, Atanackovic D, Gabrail N, Martin TG, Perrot A, Bensfia S, Weng Q, Brillac C, Semiond D, Mace S, Corzo KP, Leleu X. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab. Blood Cancer J. 2021 May 12;11(5):89. doi: 10.1038/s41408-021-00478-4. No abstract available.

repositories_concat: PubMed Central;digitalcommons.wustl.edu

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
United States
Czechia
France

location_facility:
Investigational Site Number 250005
Investigational Site Number 840003
Investigational Site Number 840013
Investigational Site Number 840010
Investigational Site Number 250006
Investigational Site Number 840006
Investigational Site Number 840005
Investigational Site Number 250008
Investigational Site Number 203001
Investigational Site Number 250002
Investigational Site Number 840011
Investigational Site Number 250004
Investigational Site Number 250001
Investigational Site Number 203002
Investigational Site Number 840004
Investigational Site Number 840002
Investigational Site Number 840015
Investigational Site Number 840001


title: A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)

acronym: Open PRIDE-HD

summary: The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).

ReferenceCitation: Cohen S, Waks Z, Elm JJ, Gordon MF, Grachev ID, Navon-Perry L, Fine S, Grossman I, Papapetropoulos S, Savola JM. Characterizing patient compliance over six months in remote digital trials of Parkinson's and Huntington disease. BMC Med Inform Decis Mak. 2018 Dec 20;18(1):138. doi: 10.1186/s12911-018-0714-7.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Prilenia

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Netherlands
Austria
United States
Canada
Russian Federation
France

location_facility:
Teva Investigational Site 30082
Teva Investigational Site 53149
Teva Investigational Site 12208
Teva Investigational Site 35123
Teva Investigational Site 34059
Teva Investigational Site 33021
Teva Investigational Site 12201
Teva Investigational Site 32410
Teva Investigational Site 12210
Teva Investigational Site 35125
Teva Investigational Site 50214
Teva Investigational Site 12196
Teva Investigational Site 53148
Teva Investigational Site 32409
Teva Investigational Site 34055
Teva Investigational Site 35122
Teva Investigational Site 32408
Teva Investigational Site 35165
Teva Investigational Site 50213
Teva Investigational Site 12209
Teva Investigational Site 35121
Teva Investigational Site 30081
Teva Investigational Site 12200
Teva Investigational Site 78057
Teva Investigational Site 11036
Teva Investigational Site 30080
Teva Investigational Site 78058
Teva Investigational Site 53150
Teva Investigational Site 34058
Teva Investigational Site 34057
Teva Investigational Site 35124
Teva Investigational Site 34061
Teva Investigational Site 50215
Teva Investigational Site 12204
Teva Investigational Site 34054
Teva Investigational Site 12211
Teva Investigational Site 78055
Teva Investigational Site 30083
Teva Investigational Site 12203
Teva Investigational Site 33027
Teva Investigational Site 38059
Teva Investigational Site 53151
Teva Investigational Site 12206
Teva Investigational Site 34056
Teva Investigational Site 32407
Teva Investigational Site 12198


acronym: INEXAS

summary: A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza

ReferenceCitation: McCrae C, Olsson M, Gustafson P, Malmgren A, Aurell M, Fageras M, Da Silva CA, Cavallin A, Paraskos J, Karlsson K, Wingren C, Monk P, Marsden R, Harrison T. INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics. Clin Exp Allergy. 2021 Feb;51(2):273-283. doi: 10.1111/cea.13765. Epub 2020 Nov 3.

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Phase IIa Study in Asthma Patients Comparing the Efficacy and Safety of Once Daily Inhaled Interferon Beta-1a to Placebo, Administered for 14 Days After the Onset of Symptoms of an Upper Respiratory Tract Infection for the Prevention of Severe Exacerbations

primary_purpose: Prevention

location_country:
Colombia
United Kingdom
Argentina
Australia
Korea, Republic of
Spain
France


summary: The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility:
Local Institution - 0175
Local Institution - 0102
Local Institution - 0182
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0072
Local Institution - 0170
Local Institution - 0044
Local Institution - 0164
Local Institution - 0126
Local Institution - 0103
Local Institution - 0095
Local Institution - 0058
Local Institution - 0096
Local Institution - 0124
Local Institution - 0190
Local Institution - 0005
Local Institution - 0063
Local Institution - 0157
Local Institution - 0148
Local Institution - 0202
Local Institution - 0106
Local Institution - 0143
Local Institution - 0166
Local Institution - 0008
Local Institution - 0107
Local Institution - 0078
Local Institution - 0201
Local Institution - 0019
Local Institution - 0097
Local Institution - 0099
Local Institution - 0188
Local Institution - 0046
Local Institution - 0110
Local Institution - 0116
Local Institution - 0042
Local Institution - 0031
Local Institution - 0138
Local Institution - 0134
Local Institution - 0132
Local Institution - 0054
Local Institution - 0149
Local Institution - 0104
Local Institution - 0090
Local Institution - 0070
Local Institution - 0173
Local Institution - 0024
Local Institution - 0069
Local Institution - 0156
Local Institution - 0023
Local Institution - 0169
Local Institution - 0033
Local Institution - 0085
Local Institution - 0139
Local Institution - 0176
Local Institution - 0109
Local Institution - 0053
Local Institution - 0025
Local Institution - 0174
Local Institution - 0155
Local Institution - 0168
Local Institution - 0079
Local Institution - 0131
Local Institution - 0066
Local Institution - 0060
Local Institution - 0159
Local Institution - 0121
Local Institution - 0154
Local Institution - 0006
Local Institution - 0196
Local Institution - 0165
Local Institution - 0112
Local Institution - 0152
Local Institution - 0119
Local Institution - 0082
Local Institution - 0150
Local Institution - 0171
Local Institution - 0083
Local Institution - 0117
Local Institution - 0161
Local Institution - 0067
Local Institution - 0059
Local Institution - 0081
Local Institution - 0146
Local Institution - 0136
Local Institution - 0186
Local Institution - 0194
Local Institution - 0181
Local Institution - 0197
Local Institution - 0028
Local Institution - 0064
Local Institution - 0061
Local Institution - 0145
Local Institution - 0151
Local Institution - 0118
Local Institution - 0108
Local Institution - 0065
Local Institution - 0047
Local Institution - 0114
Local Institution - 0004
Local Institution - 0187
Local Institution - 0010
Local Institution - 0133
Local Institution - 0089
Local Institution - 0163
Local Institution - 0122
Local Institution - 0057
Local Institution - 0030
Local Institution - 0084
Local Institution - 0018
Local Institution - 0003
Local Institution - 0189
Local Institution - 0198
Local Institution - 0041
Local Institution - 0200
Local Institution - 0080
Local Institution - 0113
Local Institution - 0027
Local Institution - 0007
Local Institution - 0055
Local Institution - 0002
Local Institution - 0032
Local Institution - 0135
Local Institution - 0147
Local Institution - 0073
Local Institution - 0012
Local Institution - 0192
Local Institution - 0160
Local Institution - 0068
Local Institution - 0020
Local Institution - 0199
Local Institution - 0062
Local Institution - 0001
Local Institution - 0022
Local Institution - 0153
Local Institution - 0094
Local Institution - 0086
Local Institution - 0100
Local Institution - 0013
Local Institution - 0185
Local Institution - 0056
Local Institution - 0123
Local Institution - 0162
Local Institution - 0093
Local Institution - 0098
Local Institution - 0183
Local Institution - 0088

title: An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

location_country:
Germany
Poland
Australia
Brazil
Japan
Chile
Czechia
France
Hungary
Denmark
Switzerland
United States
Romania
Belgium
China
Italy
Norway
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.

ReferenceCitation: Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Yenerel MN, Illes A, Kay N, Garcia-Marco JA, Mato A, Pinilla-Ibarz J, Seymour JF, Lepretre S, Stilgenbauer S, Robak T, Rothbaum W, Izumi R, Hamdy A, Patel P, Higgins K, Sohoni S, Jurczak W. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021 Nov 1;39(31):3441-3452. doi: 10.1200/JCO.21.01210. Epub 2021 Jul 26.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

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


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

summary: This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).

ipd_sharing_description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

lead_sponsor: Sage Therapeutics

location_country:
Finland
Germany
Italy
Hungary
Israel
Denmark
United Kingdom
Sweden
Netherlands
Austria
United States
Spain
Canada
Estonia
Serbia
France

location_facility:
Sage Investigational Site
Sage investigational Site


title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)

acronym: CEDAR

summary: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

lead_sponsor: Allergan

location_country:
Germany
Colombia
New Zealand
Israel
Argentina
Hong Kong
Singapore
Switzerland
Austria
United States
Korea, Republic of
Latvia
Spain
Chile
Czechia
Philippines
France

location_facility: Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)

location_facility: Medizinische Universitat Innsbruck, Univ.

location_facility: Northern California Retina Vitreous Associates Medical Group, INC.

location_facility: Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde

location_facility: Instituto Oftalmologico de Buenos Aires - Oftalmos

location_facility: The Chinese University of Hong Kong Hongkong eye hospital

location_facility: The Catholic Univ. Of Seoul St. Mary's Hospital

location_facility: Pauls Stradins Clinical University Hospital Opthalmology Clinic

location_facility: The Bert M Glaser National Retina Institute

location_facility: Clinica Universidad de Navarra Servicio de Oftalmologia

location_facility: Hopital de la Croix Rousse, Service d'Opthalmologie

location_facility: Konventhospital Barmherzige Brueder Linz

location_facility: Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika

location_facility: Kellog Eye Center - University of Michigan Health System

location_facility: Fundacion Oftalmologica Nacional - FUNDONAL

location_facility: TASMC (The Tel-Aviv Sourasky Medical Centre)

location_facility: Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona

location_facility: Stiftung für wissenschaftliche Forschung am Stadtspital Triemli

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology

location_facility: Hospital General de Valencia Unidad de Investigacion Clinica

location_facility: Atlantis Retina Institute (Atlantis Eyecare)

location_facility: Carmel Medical Center Ophthalmology Clinic

location_facility: Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie

location_facility: Instituto Oftalmologica Profesor Arentsen

location_facility: Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas

location_facility: Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center

location_facility: University Retina and Macula Associates, PC

location_facility: Seoul National University Bundang Hospital

location_facility: Clinic and policlinic of ophthalmology, University of Regensburg

location_facility: Universitatsklinik fur Augenheilkunde, Inselspital

location_facility: Instituto Clínico Quirúrgico de Oftalmología (ICQO)

location_facility: Houston Eye Associates (HEA) - Gramercy Location

location_facility: Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg

location_facility: Vseobecna fakultni nemocnice v Praze Ocni Klinika

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: University of Virginia - Department of Ophthalmology

location_facility: Yonsei University Health System Serverance Hospital


acronym: MYSTIC

summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

ReferenceCitation: Garon EB, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, Robinet G, Le Moulec S, Natale R, Schneider J, Shepherd FA, Garassino MC, Geater SL, Szekely ZP, Van Ngoc T, Liu F, Scheuring U, Patel N, Peters S, Rizvi NA. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). Clin Lung Cancer. 2021 Jul;22(4):301-312.e8. doi: 10.1016/j.cllc.2021.02.010. Epub 2021 Feb 19.

repository_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. doi: 10.1001/jamaoncol.2020.0237. Erratum In: JAMA Oncol. 2020 Nov 1;6(11):1815.

repositories_concat: PubMed Central;repository.ubn.ru.nl

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

publisher_dissemination: American Medical Association

title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).

location_country:
Germany
Italy
Hungary
Australia
Japan
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Thailand
Vietnam
Taiwan
Canada
Russian Federation
France


summary: The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior chemotherapy.

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

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

title: Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second-Line Gastric or Gastroesophageal Junction Adenocarcinoma

location_country:
Poland
New Zealand
Slovakia
Hungary
Argentina
Romania
Australia
United Kingdom
United States
Turkey
Russian Federation
France


summary: The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

ReferenceCitation: Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.

publisher_dissemination: SAGE Publications

location_facility: New England Institute for Clinical Research

location_facility: Michigan Head, Pain and Neurological Institute

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

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

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Klinikum der Universität München Campus Großhadern

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Greece
Canada
France


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

acronym: RANGE

summary: The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.

ReferenceCitation: van der Heijden MS, Powles T, Petrylak D, de Wit R, Necchi A, Sternberg CN, Matsubara N, Nishiyama H, Castellano D, Hussain SA, Bamias A, Gakis G, Lee JL, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Eigl BJ, Hozak RR, Rasmussen ER, Xia MS, Rhodes R, Wijayawardana S, Bell-McGuinn KM, Aggarwal A, Drakaki A. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial. Nat Commun. 2022 Apr 6;13(1):1878. doi: 10.1038/s41467-022-29441-y.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

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

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Necchi A, Nishiyama H, Matsubara N, Lee JL, Petrylak DP, de Wit R, Drakaki A, Liepa AM, Mao H, Bell-McGuinn K, Powles T. Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE). BMC Urol. 2020 Nov 7;20(1):181. doi: 10.1186/s12894-020-00752-w.

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

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

ReferenceCitation: Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain SA, Flechon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Geczi L, Ou YC, Coskun HS, Su WP, Bedke J, Gakis G, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Garcia Del Muro X, Rodriguez-Vida A, Cicin I, Harputluoglu H, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Hamid O, Liepa AM, Wijayawardana S, Russo F, Walgren RA, Zimmermann AH, Hozak RR, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):105-120. doi: 10.1016/S1470-2045(19)30668-0. Epub 2019 Nov 18.

ReferenceCitation: Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain S, Flechon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Geczi L, Ou YC, Coskun HS, Su WP, Hegemann M, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Del Muro XG, Rodriguez-Vida A, Cicin I, Harputluoglu H, Widau RC, Liepa AM, Walgren RA, Hamid O, Zimmermann AH, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial. Lancet. 2017 Nov 18;390(10109):2266-2277. doi: 10.1016/S0140-6736(17)32365-6. Epub 2017 Sep 12.

repository_institution: University of Plymouth - PEARL

location_country:
Germany
Poland
Australia
Japan
Turkey
Canada
France
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

location_facility: Inova Comprehensive Cancer Care & Research Institute

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

location_facility: Ivanovo regional clinical oncology dispensary

location_facility: Central Coast Medical Oncology Corporation

location_facility: St Mary's Hospital Regional Cancer Center

location_facility: University of California, Davis - Health Systems

location_facility: University of Maryland- Biological Sciences

location_facility: University of Oklahoma Health Sciences Center

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: Scientific research oncology institute n.a. P. A. Herzen

location_facility: The Center for Cancer and Blood Disorders


lead_sponsor: Geron Corporation

summary: The purpose of this study is to evaluate the efficacy and safety of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) whose disease is relapsed after or is refractory to Janus Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.

ReferenceCitation: Mascarenhas J, Komrokji RS, Palandri F, Martino B, Niederwieser D, Reiter A, Scott BL, Baer MR, Hoffman R, Odenike O, Vannucchi AM, Bussolari J, Zhu E, Rose E, Sherman L, Dougherty S, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Kiladjian JJ. Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis. J Clin Oncol. 2021 Sep 10;39(26):2881-2892. doi: 10.1200/JCO.20.02864. Epub 2021 Jun 17.

title: A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor

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


lead_sponsor: ViiV Healthcare

summary: The aim of this study is to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

ReferenceCitation: Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir plus rilpivirine for the maintenance of virologic suppression in HIV-1-infected adults: the phase III, randomized, open-label, active-controlled, noninferiority SWORD-1 and SWORD-2 studies. Lancet [epublished ahead of print] 6 January 2018.

ReferenceCitation: Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, Khuong-Josses MA, Parks D, Angelis K, Kahl LP, Blair EA, Adkison K, Underwood M, Matthews JE, Wynne B, Vandermeulen K, Gartland M, Smith K. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019 Sep;6(9):e576-e587. doi: 10.1016/S2352-3018(19)30149-3. Epub 2019 Jul 12.

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum In: Lancet. 2018 Feb 1;:

ReferenceCitation: McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

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

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

sponsor_collaborators:
ViiV Healthcare
Janssen Pharmaceuticals
GlaxoSmithKline

title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
United States
Spain
Taiwan
Canada
Russian Federation
France

collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline


lead_sponsor: Astellas Pharma Global Development, Inc.

summary:
The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants.

This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

ReferenceCitation: Smith CC, Levis MJ, Perl AE, Hill JE, Rosales M, Bahceci E. Molecular profile of FLT3-mutated relapsed/refractory patients with AML in the phase 3 ADMIRAL study of gilteritinib. Blood Adv. 2022 Apr 12;6(7):2144-2155. doi: 10.1182/bloodadvances.2021006489.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Perl AE, Larson RA, Podoltsev NA, Strickland S, Wang ES, Atallah E, Schiller GJ, Martinelli G, Neubauer A, Sierra J, Montesinos P, Recher C, Yoon SS, Hosono N, Onozawa M, Chiba S, Kim HJ, Hasabou N, Lu Q, Tiu R, Levis MJ. Follow-up of patients with R/R FLT3-mutation-positive AML treated with gilteritinib in the phase 3 ADMIRAL trial. Blood. 2022 Jun 9;139(23):3366-3375. doi: 10.1182/blood.2021011583.

ReferenceCitation: Perl AE, Martinelli G, Cortes JE, Neubauer A, Berman E, Paolini S, Montesinos P, Baer MR, Larson RA, Ustun C, Fabbiano F, Erba HP, Di Stasi A, Stuart R, Olin R, Kasner M, Ciceri F, Chou WC, Podoltsev N, Recher C, Yokoyama H, Hosono N, Yoon SS, Lee JH, Pardee T, Fathi AT, Liu C, Hasabou N, Liu X, Bahceci E, Levis MJ. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. N Engl J Med. 2019 Oct 31;381(18):1728-1740. doi: 10.1056/NEJMoa1902688. Erratum In: N Engl J Med. 2022 May 12;386(19):1868.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

publisher_dissemination: Massachusetts Medical Society

location_facility:
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title: A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

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

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Japan
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
France


title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

summary: Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

ReferenceCitation: Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Finland
Germany
Poland
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Taiwan
Czechia
Canada
France

location_facility: Albert Schweitzer Ziekenhuis, Zwijndrecht

location_facility: Royal Brisbane & Women's Hospital-Endocrinology

location_facility: Diabetology and Internal Practice Dr. Vladimir Lelek

location_facility: HOP les Portes du Sud, Diabéto, Vénissieux

location_facility: Desert Endocrinology Clinical Research Center

location_facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny

location_facility: LMC Endocrinology Centres (Calgary) Ltd.

location_facility: Oslo Universitetssykehus HF, Aker Sykehus

location_facility: MultiCare Institute for Research and Innovation

location_facility: NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

location_facility: Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan

location_facility: General Univ.hosp.in Prague (VFN), Diabetes ambulance

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Allgemeinmedizinische und Diabetologische Schwerpunktpraxis

location_facility: Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Wellcome Trust Clinical Research Facility

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

location_facility: Diabetes and Obesity Clinical Trials Center

location_facility: Albany Medical Center / Albany Medical College

location_facility: Helse Møre og Romsdal HF, Ålesund sjukehus

location_facility: Diabetes/Lipid Management and Research Center

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: University Physicians Group Research Division

location_facility: ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH

location_facility: Southern New Hampshire Diabetes and Endocrinology


title: A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations

summary: This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.

lead_sponsor: Grifols Therapeutics LLC

location_country:
Poland
Hungary
Argentina
Romania
Belgium
Latvia
South Africa
Czechia
Canada
Estonia
Russian Federation
France

location_facility: Fakultni nemocnice Ostrava, Neurologická klinika

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko

location_facility: University Health Network (UHN) - Toronto General Hospital

location_facility: University of Szeged, Faculty of Medicine

location_facility: Fakultni nemocnice Brno, Neurologicka klinika

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

intervention_type: Biological


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

summary: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

ReferenceCitation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

repositories_institution: California Digital Library - eScholarship

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Hungary
Argentina
United Kingdom
Australia
Mexico
Belgium
Korea, Republic of
Taiwan
Czechia
Ukraine
Russian Federation
France


title: An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.

summary: To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

ReferenceCitation: Lenz G, Hawkes E, Verhoef G, Haioun C, Thye Lim S, Seog Heo D, Ardeshna K, Chong G, Haaber J, Shi W, Gorbatchevsky I, Lippert S, Hiemeyer F, Piraino P, Beckmann G, Pena C, Buvaylo V, Childs BH, Salles G. Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. Leukemia. 2020 Aug;34(8):2184-2197. doi: 10.1038/s41375-020-0743-y. Epub 2020 Feb 14.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: KU Leuven - Lirias

repositories:
LIRIAS (KU Leuven)
PubMed Central
sdu.dk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;sdu.dk

location_country:
Germany
Italy
United Kingdom
Singapore
Denmark
Australia
Belgium
Korea, Republic of
Canada
France