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

acronym: APEKS-NP

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

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

family: Wunderink

full_name: Richard G Wunderink

given: Richard G

family: Matsunaga

full_name: Yuko Matsunaga

given: Yuko

family: Ariyasu

full_name: Mari Ariyasu

given: Mari

family: Clevenbergh

full_name: Philippe Clevenbergh

given: Philippe

family: Echols

full_name: Roger Echols

given: Roger

family: Kaye

full_name: Keith S Kaye

given: Keith S

family: Kollef

full_name: Marin Kollef

given: Marin

family: Menon

full_name: Anju Menon

given: Anju

family: Pogue

full_name: Jason M Pogue

given: Jason M

family: Shorr

full_name: Andrew F Shorr

given: Andrew F

family: Timsit

full_name: Jean-Francois Timsit

given: Jean-Francois

family: Zeitlinger

full_name: Markus Zeitlinger

given: Markus

family: Nagata

full_name: Tsutae D Nagata

given: Tsutae D

journal_name: The Lancet Infectious Diseases

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Shionogi

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


title: Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

summary: The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Medtronic

location_country:
Italy
United States
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Japan
Greece
Malaysia
Hungary
Belgium
China
Canada
Slovenia
Korea, Republic of

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Pharmacyclics LLC.

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
Austria
United States
Netherlands
Spain
France
Czechia
Greece
Israel
Poland
Hungary
Australia
Belgium
New Zealand
Portugal
Russian Federation
Canada
United Kingdom
Turkey
Taiwan

acronym: PERSPECTIVE

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov

location_facility: Royal Berkshire Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: W VA University Mary Babb Randolph Cancer Center

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

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

location_facility: Azienda ospedaliera Universiataria Senese

location_facility: Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Roy and Patricia Disney Family Cancer Center

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika

location_facility: Oncology and Hematology Associates of Southwest Virginia (Blacksburg)

location_facility: Helen F. Graham Cancer Center and Research Institute

location_facility: Azienda Sanitaria Ospedaliera S. Croce e Carle

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Royal Cornwall Hospital - Hospital Treliske

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

location_facility: Policlinico Universitario Campus Biomedico di Roma

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

location_facility: OHSU Knight Cancer Institute Beaverton Clinic

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Farmacia Polo Ematologico Policlinico Umberto I

location_facility: Namik Kemal Universitesi Tip Fakultesi Hastanesi

location_facility: University of Texas Southwestern Medical Center

type: EudraCT Number

source: euctr

title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)

summary: The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.


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.

lead_sponsor: Astellas Pharma Global Development, Inc.

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

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

ipd_sharing: Yes

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

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


intervention_type: Other

status: Completed

lead_sponsor: Bristol-Myers Squibb

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

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

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

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

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

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

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

study_completion_date_type: Actual

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

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

status_simplified: Completed


ReferenceType: derived

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

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

name: Nuffield Department of Surgical Sciences; University of Oxford; Oxford UK

family: Chong

full_name: Lee-Yee Chong

given: Lee-Yee

sequence: additional

name: Department of Otorhinolaryngology; Faculty of Medicine, Khon Kaen University; Khon Kaen Thailand

family: Piromchai

full_name: Patorn Piromchai

given: Patorn

name: National Institute for Health and Care Excellence; Manchester UK

family: Sharp

full_name: Steve Sharp

given: Steve

name: Department of Otolaryngology, Faculty of Medicine; Chulalongkorn University; Bangkok Thailand

family: Snidvongs

full_name: Kornkiat Snidvongs

given: Kornkiat

name: Cochrane ENT; Nuffield Department of Surgical Sciences, University of Oxford; Oxford UK

family: Webster

full_name: Katie E Webster

given: Katie E

name: Department of Medicine; Norwich Medical School, University of East Anglia; Norwich UK

family: Philpott

full_name: Carl Philpott

given: Carl

name: ENT Department; Guy's Hospital; London UK

family: Hopkins

full_name: Claire Hopkins

given: Claire

family: Burton

full_name: Martin J Burton

given: Martin J

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of East Anglia - UEA Digital Repository

version: acceptedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Biologics for chronic rhinosinusitis

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

name: ENT Department Guy's and St Thomas' Hospitals  London UK

sequence: first

name: Department of Otorhinolaryngology Düsseldorf University Hospital (UKD)  Düsseldorf Germany

family: Wagenmann

full_name: Martin Wagenmann

given: Martin

name: Department of Otorhinolaryngology Ghent University  Ghent Belgium

name: Division of ENT diseases Karolinska Institutet  Stockholm Sweden

name: First Affiliated Hospital, Sun Yat‐sen University  Guangzhou China

family: Bachert

full_name: Claus Bachert

given: Claus

name: Department of Otorhinolaryngology Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)  Montréal QC Canada

family: Desrosiers

full_name: Martin Desrosiers

name: Division of Allergy, Rhinology and Skull Base Surgery Eastern Virginia Medical School  Norfolk VA USA

family: Han

full_name: Joseph K. Han

given: Joseph K.

name: Department of Otorhinolaryngology University Hospitals Leuven  Leuven Belgium

family: Hellings

full_name: Peter W. Hellings

given: Peter W.

name: Department of Otorhinolaryngology University of Pittsburgh Medical Center  Pittsburgh PA USA

family: Lee

full_name: Stella E. Lee

given: Stella E.

family: Msihid

full_name: Jérôme Msihid

given: Jérôme

name: Regeneron Pharmaceuticals, Inc.  Uxbridge London UK

family: Radwan

full_name: Amr Radwan

given: Amr

family: Rowe

full_name: Paul Rowe

given: Paul

name: Regeneron Pharmaceuticals, Inc.  Tarrytown NY USA

family: Amin

full_name: Nikhil Amin

given: Nikhil

family: Deniz

full_name: Yamo Deniz

given: Yamo

family: Ortiz

full_name: Benjamin Ortiz

given: Benjamin

journal_name: International Forum of Allergy & Rhinology

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

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

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

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

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

location_facility:
Investigational Site Number 3800001
Investigational Site Number 1000002
Investigational Site Number 8400003
Investigational Site Number 3800005
Investigational Site Number 3800003
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Investigational Site Number 5280001
Investigational Site Number 6420003
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Investigational Site Number 6430007
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Investigational Site Number 6420010
Investigational Site Number 6430003
Investigational Site Number 3480005
Investigational Site Number 6430001
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Investigational Site Number 6420009
Investigational Site Number 8400013
Investigational Site Number 2500001
Investigational Site Number 3800007
Investigational Site Number 8400019
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Investigational Site Number 2500004
Investigational Site Number 2760002
Investigational Site Number 2500006
Investigational Site Number 3480003
Investigational Site Number 6430006
Investigational Site Number 8040002
Investigational Site Number 8260005
Investigational Site Number 3480001
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Investigational Site Number 3480006
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Investigational Site Number 3480007
Investigational Site Number 3480004
Investigational Site Number 8260001
Investigational Site Number 3480002
Investigational Site Number 6160003
Investigational Site Number 8400015
Investigational Site Number 2500007
Investigational Site Number 1000003
Investigational Site Number 8040008
Investigational Site Number 6430002
Investigational Site Number 8040006
Investigational Site Number 8400005
Investigational Site Number 8400014
Investigational Site Number 6420013
Investigational Site Number 6420007
Investigational Site Number 8040001
Investigational Site Number 6160002
Investigational Site Number 6160001
Investigational Site Number 8400018
Investigational Site Number 2500005
Investigational Site Number 8400007

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

summary:
Primary Objective:

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

Secondary Objectives:

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


lead_sponsor: Janssen Research & Development, LLC

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

acronym: TRIDENT

type: Other Identifier

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

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


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

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

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

family: Trigg

full_name: Andrew Trigg

given: Andrew

family: Brohan

full_name: Elaine Brohan

given: Elaine

family: Cocks

full_name: Kim Cocks

given: Kim

family: Jones

full_name: Amy Jones

given: Amy

family: Tahami Monfared

full_name: Amir A. Tahami Monfared

given: Amir A.

family: Chabot

full_name: Isabelle Chabot

given: Isabelle

family: Meier

full_name: Genevieve Meier

given: Genevieve

family: Campbell

full_name: Renee Campbell

given: Renee

family: Li

full_name: Huimin Li

given: Huimin

family: Ngo

full_name: Leock Y. Ngo

given: Leock Y.

journal_name: Epilepsy & Behavior

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

name: Epilepsy Center Bethesda Children’s Hospital Budapest Hungary

family: Fogarasi

full_name: Andras Fogarasi

given: Andras

name: Pediatric and Adolescent Neurodevelopmental Associates Atlanta GA USA

family: Flamini

full_name: Robert Flamini

given: Robert

name: Pediatric Neurology Unit La Timone Enfants Hospital Marseille France

family: Milh

full_name: Mathieu Milh

given: Mathieu

name: Mary Bridge Children’s Neurology Clinic Tacoma WA USA

family: Phillips

full_name: Steven Phillips

given: Steven

name: NHO Shizuoka Institute of Epilepsy and Neurological Disorders Shizuoka Japan

family: Yoshitomi

full_name: Shinsaku Yoshitomi

given: Shinsaku

family: Patten

full_name: Anna Patten

given: Anna

family: Takase

full_name: Takao Takase

given: Takao

name: Formerly: Eisai Inc. Woodcliff Lake NJ USA

family: Laurenza

full_name: Antonio Laurenza

given: Antonio

journal_name: Epilepsia

oa_colors: green hybrid

title: Open‐label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic‐clonic seizures

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

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


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

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

ipd_sharing: No

lead_sponsor: Theracos

location_country:
United States
France
Japan
Spain

location_facility:
Research site
Research Site


ReferenceType: background

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

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

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

name: Institute of Cardiovascular Science; University College London; London UK

name: Department of Cardiology, Division Heart and Lungs; UMC Utrecht; Utrecht Netherlands

family: Schmidt

full_name: Amand F Schmidt

given: Amand F

name: Department of Clinical Pharmacology and Therapeutics; University College London Hospital; London UK

family: Carter

full_name: John-Paul L Carter

given: John-Paul L

name: Department of Non-communicable Disease Epidemiology; London School of Hygiene & Tropical Medicine; London UK

family: Pearce

full_name: Lucy S Pearce

given: Lucy S

name: The Department of Medicine (Cardiology) and the Department of Preventive Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wilkins

full_name: John T Wilkins

given: John T

name: Medicines Discovery Catapult; Alderly Edge UK

family: Overington

full_name: John P Overington

given: John P

family: Hingorani

full_name: Aroon D Hingorani

given: Aroon D

name: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); VA Boston Healthcare System; Boston Massachusetts USA

family: Casas

full_name: JP Casas

given: JP

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: publishedVersion

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

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

lead_sponsor: Amgen

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

acronym: BEIJERINCK

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

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

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


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

name: From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis...

family: Hauser

full_name: Stephen L. Hauser

given: Stephen L.

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Cohen

full_name: Jeffrey A. Cohen

given: Jeffrey A.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Correale

full_name: Jorge Correale

given: Jorge

family: Coyle

full_name: Patricia K. Coyle

given: Patricia K.

family: Cross

full_name: Anne H. Cross

given: Anne H.

family: de Seze

full_name: Jerome de Seze

given: Jerome

family: Leppert

full_name: David Leppert

given: David

family: Montalban

full_name: Xavier Montalban

given: Xavier

family: Selmaj

full_name: Krzysztof Selmaj

given: Krzysztof

family: Wiendl

full_name: Heinz Wiendl

given: Heinz

family: Kerloeguen

full_name: Cecile Kerloeguen

given: Cecile

family: Willi

full_name: Roman Willi

given: Roman

family: Li

full_name: Bingbing Li

given: Bingbing

family: Kakarieka

full_name: Algirdas Kakarieka

given: Algirdas

family: Tomic

full_name: Davorka Tomic

given: Davorka

family: Goodyear

full_name: Alexandra Goodyear

given: Alexandra

family: Pingili

full_name: Ratnakar Pingili

given: Ratnakar

family: Häring

full_name: Dieter A. Häring

given: Dieter A.

family: Ramanathan

full_name: Krishnan Ramanathan

given: Krishnan

family: Merschhemke

full_name: Martin Merschhemke

given: Martin

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

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

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

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


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

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

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

name: French Referral Center for Cardiac Amyloidosis, Amyloidosis Mondor Network, GRC Amyloid Research Institute and Department of Cardiology, all at APHP, CHU Henri Mondor; and INSERM U955, Clinical Investigation Center 006, and DHU ATVB  Créteil France

family: Damy

full_name: Thibaud Damy

given: Thibaud

name: Hospital Universitario Puerta de Hierro Majadahonda, CIBERCV  Madrid Spain

name: Universidad Francisco de Vitoria, Pozuelo de Alarcon  Madrid Spain

family: Garcia‐Pavia

full_name: Pablo Garcia‐Pavia

given: Pablo

name: Amyloidosis Centre Cleveland Clinic  Cleveland OH USA

family: Hanna

full_name: Mazen Hanna

given: Mazen

name: Medical University of South Carolina  Charleston SC USA

family: Judge

full_name: Daniel P. Judge

given: Daniel P.

name: Amyloidosis Center IRCCS Policlinico San Matteo and University of Pavia  Pavia Italy

family: Merlini

full_name: Giampaolo Merlini

given: Giampaolo

family: Gundapaneni

full_name: Balarama Gundapaneni

given: Balarama

family: Patterson

full_name: Terrell A. Patterson

given: Terrell A.

family: Riley

full_name: Steven Riley

given: Steven

family: Schwartz

full_name: Jeffrey H. Schwartz

given: Jeffrey H.

family: Sultan

full_name: Marla B. Sultan

given: Marla B.

name: Stanford University School of Medicine  Stanford CA USA

family: Witteles

full_name: Ronald Witteles

given: Ronald

journal_name: European Journal of Heart Failure

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

title: Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial ( ATTR‐ACT ) and long‐term extension study

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

full_name: Benjamin Li

given: Benjamin

family: Alvir

full_name: Jose Alvir

given: Jose

family: Stewart

full_name: Michelle Stewart

given: Michelle

journal_name: Cardiology and Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

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

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

location_facility: Montreal Heart Institute-Research Center

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

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Cardiovascular Clinical Trials Unit (CCTU)

location_facility: Boston Medical Center Investigational Pharmacy

location_facility: Stanford Hospital and Clinics Investigational Pharmacy

location_facility: UCSF Cardiovascular Care and Prevention Center

location_facility: Hospital Universitário Clementino Fraga Filho (UFRJ)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Utah, Division of Cardiovascular Medicine

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Altman Clinical Translational Research Institute

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

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

location_facility: Stanford University Hospital and Clinics

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

location_facility: University Hospital, University of Alabama at Birmingham

location_facility: University health network-Toronto General Hospital

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

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University of Calgary/Foothills Medical Centre

location_facility: Michigan Medicine,University of Michigan

location_facility: Institut klinicke a experimentalni mediciny


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

family: Glaspole

full_name: Ian Glaspole

given: Ian

family: Bonella

full_name: Francesco Bonella

given: Francesco

family: Bargagli

full_name: Elena Bargagli

given: Elena

family: Glassberg

full_name: Marilyn K. Glassberg

given: Marilyn K.

family: Caro

full_name: Fabian Caro

given: Fabian

family: Stansen

full_name: Wibke Stansen

given: Wibke

family: Quaresma

full_name: Manuel Quaresma

given: Manuel

family: Orsatti

full_name: Leticia Orsatti

given: Leticia

family: Bendstrup

full_name: Elisabeth Bendstrup

given: Elisabeth

currency_apc_doaj: GBP

journal_name: Respiratory Research

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

family: Noth

full_name: Imre Noth

given: Imre

family: Cottin

full_name: Vincent Cottin

given: Vincent

family: Chaudhuri

full_name: Nazia Chaudhuri

given: Nazia

family: Corte

full_name: Tamera J. Corte

given: Tamera J.

family: Johannson

full_name: Kerri A. Johannson

given: Kerri A.

family: Wijsenbeek

full_name: Marlies Wijsenbeek

given: Marlies

family: Jouneau

full_name: Stephane Jouneau

given: Stephane

family: Michael

full_name: Andreas Michael

given: Andreas

family: Rohr

full_name: Klaus B. Rohr

given: Klaus B.

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

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

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

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

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

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: University of Florida College of Medicine

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

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

location_facility: Practice of Internists "Nasz Lekarz", Torun

location_facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept

location_facility: Our Doctor Clinical Trial Center, Department in Bydgoszcz

location_facility: Concord General Repatriation Hospital -Ambulatory Care Unit

location_facility: BAZ County Central Hospital and University Teaching Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Seoul National University Bundang Hospital

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Pulmonology Institute of Veszprem County, Farkasgyepu

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

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Klinikum der Universität München - Campus Großhadern

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

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


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

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

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

family: Starr

full_name: H. Lynn Starr

given: H. Lynn

family: Abell

full_name: Jill Abell

given: Jill

family: Larish

full_name: Allyson Larish

given: Allyson

family: Lewis

full_name: Sandy Lewis

given: Sandy

family: DeMuro

full_name: Carla DeMuro

given: Carla

family: Gogate

full_name: Jagadish Gogate

given: Jagadish

family: Jamieson

full_name: Carol Jamieson

given: Carol

family: Daly

full_name: Ella Daly

given: Ella

family: Zaki

full_name: Naim Zaki

given: Naim

family: Kramer

full_name: Michelle Kramer

given: Michelle

bso_classification: Social sciences

journal_name: Psychiatry Research

oa_host_type: publisher

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


design_allocation: Non-Randomized

status: Terminated

lead_sponsor: Hoffmann-La Roche

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

acronym: Omaspect

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: UCSF Comprehensive Cancer Ctr; Ophthalmology

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Instituto Clinico Quirurgico de Oftalmologia - ICQO

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

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

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

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

location_facility: FISABIO. Fundación Oftalmologica del Mediterraneo

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

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

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

location_facility: University of California, Davis, Eye Center

location_facility: Centre Monticelli Paradis d Ophtalmologie

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Retina & Vitreous Center of Southern Oregon

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: University of Michigan, Kellogg Eye Center

location_facility: Uni of Alabama At Birmingham Clinical Research Unit

location_facility: Inselspital Bern, Universitätsklinik für Augenheilkunde

location_facility: Hospital Perpetuo Socorro; Servicio de Oftalmología

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Retina-Vitreous Associates Medical Group

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

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

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

location_facility: Centre Odeon; Exploration Ophtalmologique

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

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

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

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

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

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

location_facility: Macular Treatment Centre; Royal Eye Hospital

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

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

location_facility: Southeastern Retina Associates Chattanooga

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

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

status_simplified: Unknown


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

family: McInnes

full_name: Iain B McInnes

given: Iain B

family: Behrens

full_name: Frank Behrens

given: Frank

family: Mease

full_name: Philip J Mease

given: Philip J

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

family: Ritchlin

full_name: Christopher Ritchlin

given: Christopher

family: Nash

full_name: Peter Nash

given: Peter

family: Masmitja

full_name: Jordi Gratacós Masmitja

given: Jordi Gratacós

family: Goupille

full_name: Philippe Goupille

given: Philippe

family: Korotaeva

full_name: Tatiana Korotaeva

given: Tatiana

family: Gottlieb

full_name: Alice B Gottlieb

given: Alice B

family: Martin

full_name: Ruvie Martin

given: Ruvie

family: Ding

full_name: Kevin Ding

given: Kevin

family: Pellet

full_name: Pascale Pellet

given: Pascale

family: Mpofu

full_name: Shephard Mpofu

given: Shephard

family: Pricop

full_name: Luminita Pricop

given: Luminita

journal_name: The Lancet

intervention_type: Biological

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

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

lead_sponsor: Novartis Pharmaceuticals

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

acronym: EXCEED 1

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

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


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

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

lead_sponsor: NeuroDerm Ltd.

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

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

location_facility: Indywidualna Praktyka Lekarska prof. dr hab

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Parkinsons Disease Treatment Center of Southwest Florida

location_facility: Hadassah Medical Center, Ein-Kerem Campus

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: USF Health Parkinson's Disease and Movement Disorders

location_facility: University of Florida Health at Jacksonville

location_facility: The Parkinsons and Movement Disorder Institute

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


title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

acronym: GARNET

summary: This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.

ReferenceCitation: Patnaik A, Weiss GJ, Rasco DW, Blaydorn L, Mirabella A, Beeram M, Guo W, Lu S, Danaee H, McEachern K, Im E, Sachdev JC. Safety, antitumor activity, and pharmacokinetics of dostarlimab, an anti-PD-1, in patients with advanced solid tumors: a dose-escalation phase 1 trial. Cancer Chemother Pharmacol. 2021 Nov 8. doi: 10.1007/s00280-021-04358-3. [Epub ahead of print]

family: Patnaik

full_name: Amita Patnaik

given: Amita

family: Weiss

full_name: Glen J. Weiss

given: Glen J.

family: Rasco

full_name: Drew W. Rasco

given: Drew W.

family: Blaydorn

full_name: Lisa Blaydorn

given: Lisa

family: Mirabella

full_name: Amy Mirabella

given: Amy

family: Beeram

full_name: Murali Beeram

given: Murali

family: Guo

full_name: Wei Guo

given: Wei

family: Lu

full_name: Sharon Lu

given: Sharon

family: Danaee

full_name: Hadi Danaee

given: Hadi

family: McEachern

full_name: Kristen McEachern

given: Kristen

family: Im

full_name: Ellie Im

given: Ellie

family: Sachdev

full_name: Jasgit C. Sachdev

given: Jasgit C.

journal_name: Cancer Chemotherapy and Pharmacology

title: Safety, antitumor activity, and pharmacokinetics of dostarlimab, an anti-PD-1, in patients with advanced solid tumors: a dose–escalation phase 1 trial

ReferenceCitation: Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical activity and safety of the anti-PD-1 monoclonal antibody dostarlimab for patients with recurrent or advanced dMMR endometrial cancer. Future Oncol. 2021 Oct 1;17(29):3781-3785. doi: 10.2217/fon-2021-0598. Epub 2021 Aug 24.

name: Medical Oncology Department, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain

family: Oaknin

full_name: Ana Oaknin

given: Ana

name: Division of Medical Oncology, BC Cancer–Vancouver, Vancouver, British Columbia, Canada

family: Tinker

full_name: Anna V Tinker

given: Anna V

name: Division of Gynecologic Oncology, McGill University Health Centre, Montreal, Quebec, Canada

family: Gilbert

full_name: Lucy Gilbert

given: Lucy

name: Gynecologic Oncology Service, Department of Obstetrics and Gynecology, Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada

family: Samouëlian

full_name: Vanessa Samouëlian

given: Vanessa

name: Women and Infants’ Program in Women’s Oncology, Women and Infants Hospital of Rhode Island, Providence, Rhode Island

family: Mathews

full_name: Cara Mathews

given: Cara

name: Levine Cancer Institute, Division of Gynecologic Oncology, Atrium Health, Charlotte, North Carolina

family: Brown

full_name: Jubilee Brown

given: Jubilee

name: Medical Oncology Department, Catalan Institute of Oncology, Girona, Spain

name: Girona Biomedical Research Institute, Department of Medical Sciences, Medical School University of Girona, Girona, Spain

family: Barretina-Ginesta

full_name: Maria-Pilar Barretina-Ginesta

name: START Madrid-Fundación Jiménez Díaz, Hospital Fundación Jiménez Díaz, Madrid, Spain

name: Struttura Complessa Sperimentazioni Cliniche, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Pascale, Naples, Italy

name: Department of Gynecological Oncology, Centre de Lutte Contre le Cancer–Centre Oscar Lambret, Lille, France

name: Gynaecology Unit, The Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom

name: Oncology Development Bioststats Unit, GlaxoSmithKline, Waltham, Massachusetts

name: Experimental Medicine Unit, GlaxoSmithKline, Waltham, Massachusetts

name: Oncology Clinical Development—Immuno-Oncology Clinical Unit, GlaxoSmithKline, Waltham, Massachusetts

name: Institut Paoli-Calmettes, Centre de Recherche en Cancérologie de Marseille–Predictive Oncology Laboratory, Centre de Recherche en Cancérologie de Marseille, Department of Medical Oncology, Aix-Marseille University, Inserm, Centre National de la Recherche Scientifique, Marseille, France

ReferenceCitation: Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):1766-1772. doi: 10.1001/jamaoncol.2020.4515.

title: Clinical Activity and Safety of the Anti–Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair–Deficient Endometrial Cancer

location_country:
Italy
France
Czechia
Poland
Spain
Denmark
United States
United Kingdom
Canada


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

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

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

ReferenceCitation: Berenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Oct 9:e14975. doi: 10.1111/ijcp.14975. [Epub ahead of print]

name: Sorbonne University INSERM, AP‐HP Saint Antoine Hospital  Paris France

family: Berenbaum

full_name: Francis Berenbaum

given: Francis

name: Northwestern University Feinberg School of Medicine  Chicago United States of America

family: Schnitzer

full_name: Thomas Schnitzer

given: Thomas

name: Altoona Center for Clinical Research  Duncansville United States of America

family: Kivitz

full_name: Alan Kivitz

given: Alan

name: Eli Lilly & Company  Indianapolis United States of America

family: Viktrup

full_name: Lars Viktrup

given: Lars

family: Johnston

full_name: Elizabeth Johnston

given: Elizabeth

name: Pfizer Inc  New York United States of America

family: Yang

full_name: Ruoyong Yang

given: Ruoyong

family: Whalen

full_name: Ed Whalen

given: Ed

family: Tive

full_name: Leslie Tive

given: Leslie

family: Semel

full_name: David Semel

given: David

journal_name: International Journal of Clinical Practice

evidence: open (via page says license)

title: Gender, age, disease severity, body mass index, and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo‐controlled trials

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

name: Department of Rheumatology Sorbonne UniversitéINSERM CRSAAP‐HP Hopital Saint Antoine Paris France

name: Pain and Anaesthesia Research Centre St Bartholomew's Hospital London UK

family: Langford

full_name: Richard Langford

given: Richard

name: Cochin HospitalParis UniversityINSERM U987 Paris France

family: Perrot

full_name: Serge Perrot

given: Serge

name: Faculty of Health Science Osaka Yukioka College of Health ScienceHayaishi Hospital Osaka Japan

family: Miki

full_name: Kenji Miki

given: Kenji

name: Servicio de Reumatología INIBC‐Complejo Hospitalario Universitario A CoruñaUniversidad de A CoruñaCICA‐INIBIC La Coruña Spain

family: Blanco

full_name: Francisco J Blanco

given: Francisco J

family: Yamabe

full_name: Takaharu Yamabe

given: Takaharu

family: Isogawa

full_name: Naoki Isogawa

given: Naoki

family: Junor

full_name: Rod Junor

given: Rod

family: Carey

full_name: William Carey

given: William

name: Eli Lilly and Company Indianapolis IN USA

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

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

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

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

location_facility: Corporació Sanitaria Parc Taulí de Sabadell

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: Multiprofile Hospital for Active Treatment-Silistra AD

location_facility: Hospital General Universitario de Guadalajara

location_facility: Avdelningen for kliniska provningar, S-huset

location_facility: Complejo Hospital Universitario A Coruna (CHUAC)

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

location_facility: Hospital Universitario La Paz Servicio de Farmacia

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

location_facility: Clinical Trials, Bradford on Avon Health Centre

location_facility: Unite Clinique Therapeutique des Maladies Osteoarticulaires

location_facility: Rheumazentrum Prof. Dr. med Gunther Neeck

location_facility: Farmacia AOUC Settore Sperimentazione Farmaci

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

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

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

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

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Diagnostic Consultative Center XIV- Sofia EOOD

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

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

location_facility: Hospital Universitario La Princesa Farmacia - Ensayos Clinicos

location_facility: National Hospital Organization Osaka Minami Medical Center

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

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

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

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

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

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

location_facility: Azienda Ospedaliero-Universitaria E Policlinico Umberto I

location_facility: Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,

location_facility: Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital

location_facility: National Hospital Organization Utsunomiya national Hospital

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

location_facility: Sonodakai Joint Replacement Center Hospital

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Centrum Terapii Wspolczesnej J.M Jasnorzewska

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

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

location_facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

location_facility: Kitasato University Kitasato Institute Hospital


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

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

family: Yamaoka

full_name: Kunihiro Yamaoka

given: Kunihiro

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Kameda

full_name: Hideto Kameda

given: Hideto

family: Khan

full_name: Nasser Khan

given: Nasser

family: Sasaki

full_name: Nobuhito Sasaki

given: Nobuhito

family: Harigai

full_name: Masayoshi Harigai

given: Masayoshi

family: Song

full_name: Yanna Song

given: Yanna

family: Zhang

full_name: Ying Zhang

given: Ying

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

journal_name: Drug Safety

license: cc-by-nc

license_normalized: cc-by-nc

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

family: Cohen

full_name: Stanley B Cohen

given: Stanley B

family: van Vollenhoven

full_name: Ronald F van Vollenhoven

given: Ronald F

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

family: Zerbini

full_name: Cristiano A F Zerbini

given: Cristiano A F

family: Bessette

full_name: Louis Bessette

given: Louis

family: Hendrickson

full_name: Barbara Hendrickson

given: Barbara

family: Enejosa

full_name: Jeffrey V Enejosa

given: Jeffrey V

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

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

name: Clinical Pharmacology and Pharmacometrics AbbVie North Chicago Illinois USA

name: Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH & Co. KG Ludwigshafen am Rhein Germany

name: Immunology Clinical Development AbbVie North Chicago Illinois USA

title: Exposure–Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit–Risk Assessment in Rheumatoid Arthritis

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

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

location_facility: Rheuma Zentrum Favoriten GmbH /ID# 142421

location_facility: Timaru Medical Specialists Ltd /ID# 142657

location_facility: Trinity Universal Research Association /ID# 149278

location_facility: Centre Hospitalier Jean Rougie /ID# 142556

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

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 142820

location_facility: Rheum Assoc of North Alabama /ID# 145959

location_facility: AZ Arthritis and Rheum Researc /ID# 146075

location_facility: Mid Essex Hospitals NHS Trust /ID# 148992

location_facility: Wilhelminenspital der Stadt Wien /ID# 142422

location_facility: Clinical Investigation Special /ID# 149270

location_facility: Deerbrook Medical Associates /ID# 151712

location_facility: LMU Klinikum der Universität München /ID# 142564

location_facility: Centrum Medyczne AMED Warszawa Targowek /ID# 142663

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

location_facility: Joint & Muscle Research Instit /ID# 142797

location_facility: Hacettepe University Medical Faculty /ID# 142729

location_facility: Hanyang University Seoul Hospi /ID# 150883

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

location_facility: Hopital Universitaire Purpan /ID# 144697

location_facility: Stanford University School of Med /ID# 142761

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

location_facility: Narodny ustav reumatickych chorob Piestany /ID# 142691

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

location_facility: AZ Arthritis and Rheum Assoc /ID# 148593

location_facility: AZ Arthritis and Rheum Researc /ID# 148592

location_facility: Arthritis Care and Diagnostic /ID# 151344

location_facility: Arthritis & Osteo Medical Ctr /ID# 142770

location_facility: HFR Fribourg - Hopital Canton /ID# 142723

location_facility: Lovelace Scientific Resources /ID# 142779

location_facility: Coastal Carolina Health Care /ID# 148351

location_facility: Centrum Medyczne Pratia Warszawa /ID# 142667

location_facility: Arthritis & Osteoporosis Assoc /ID# 147567

location_facility: Vital Medical Center Orvosi es /ID# 142586

location_facility: Ankara Ataturk Training & Res /ID# 142727

location_facility: Western Washington Arthritis C /ID# 142776

location_facility: Arthritis & Osteoporosis Clinic /ID# 142760

location_facility: Seoul National University Hospital /ID# 142622

location_facility: North Shore University Hospital /ID# 142772

location_facility: Pacific Arthritis Ctr Med Grp /ID# 142783

location_facility: Medizinische Universität Wien /ID# 142424

location_facility: Ondokuz mayis University Facul /ID# 142728

location_facility: Dartmouth-Hitchcock Medical Center /ID# 145958

location_facility: Paijat-Hame Central Hospital /ID# 149185

location_facility: General Hospital of Athens Laiko /ID# 142579

location_facility: Healthcare Research Consultant /ID# 142815

location_facility: Arthritis Research of Florida /ID# 142811

location_facility: Hospital Universitario La Fe /ID# 142716

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

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

location_facility: Diagnostic Group Integrated He /ID# 148340

location_facility: The Center for Rheumatology & /ID# 142742

location_facility: Revita Reumatologiai Rendelo /ID# 142590

location_facility: Houston Institute for Clin Res /ID# 142768

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

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

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

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

location_facility: The Queen Elizabeth Hospital /ID# 142419

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

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

location_facility: Arthritis Clinic of Central TX /ID# 148346

location_facility: Bekes Megyei Pandy Kalman Korh /ID# 142588

location_facility: Centro Hospitalar De Vila Nova /ID# 142670

location_facility: Orebro Universitetssjukhuset /ID# 142718

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

location_facility: AZ Arthritis and Rheum Researc /ID# 142816

location_facility: St. Joseph Heritage Healthcare /ID# 149273

location_facility: East Tallinn Central Hospital /ID# 142543

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 144700

location_facility: Trinity Health Med Arts Clinic /ID# 142754

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

location_facility: Centrum Medyczne Pratia Gdynia /ID# 142666

location_facility: Rheumatic Disease Clin Res Ctr /ID# 150914

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

location_facility: Schoen Klinikum Hamburg Eilbek /ID# 142566

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

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 142597

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

location_facility: North Mississippi Med Clinics /ID# 142781

location_facility: Vanguard Medical Research, LLC /ID# 153123

location_facility: Revmatologie MUDr. Klara Sirova /ID# 142536

location_facility: Universitaetsklinik fuer Inner /ID# 142423

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

location_facility: Clinical Pharmacology Study Gr /ID# 142744

location_facility: Hospital Clin Univ San Carlos /ID# 142711

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

location_facility: West Tennessee Research Inst /ID# 142739

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

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 142559

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

location_facility: East Penn Rheumatology Assoc /ID# 142790

location_facility: Clinical Research Ctr Reading /ID# 151714

location_facility: Rheumatology Ctr of San Diego /ID# 153576

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

location_facility: Rheumatology Clinic of Houston /ID# 150915

location_facility: Cliniques Universitaires Saint Luc /ID# 142426

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

location_facility: AZ Arthritis & Rheum Research /ID# 156090

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

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

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

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


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

acronym: SPINET

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

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

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

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

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

lead_sponsor: Ipsen

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

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

location_facility: Azienda Ospedaliera Universitaria di Perugia Santa Maria della Misericordia

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

location_facility: Johann Wolfgang Goethe-Universitätsklinikum Frankfurt

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Zakladu Medycyny Nuklearne i Endokrynologii Onkologicznej

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

location_facility: AKH und Med. University Vienna Allg Krankenhaus Wien

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

location_facility: University Center of Ophtalmology & Oncology


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

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD

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

name: From Stanford University School of Medicine, Palo Alto, CA (G.M.C., E.F.L.); Renal Associates, San Antonio (P.E.P.), U.S. Renal Care, Plano (G.A.B.), Baylor University Medical Center, Baylor Heart and Vascular Hospital, Baylor Heart and Vascular Institute, Dallas (P.A.M.), and the Section of Nephrology, Baylor College of Medicine, Houston (W.C.W.) — all in Texas; Akebia Therapeutics, Cambridge (Y.M.K.F., S.B., Z.K., W.L., B.J.M., A.S., D.L.V.), and the Division of Nephrology, Tufts Medical Center, Tufts...

family: Chertow

full_name: Glenn M. Chertow

given: Glenn M.

family: Pergola

full_name: Pablo E. Pergola

given: Pablo E.

family: Farag

full_name: Youssef M.K. Farag

given: Youssef M.K.

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

family: Arnold

full_name: Susan Arnold

given: Susan

family: Bako

full_name: Gabriel Bako

given: Gabriel

family: Block

full_name: Geoffrey A. Block

given: Geoffrey A.

family: Burke

full_name: Steven Burke

given: Steven

family: Castillo

full_name: Fausto P. Castillo

given: Fausto P.

family: Jardine

full_name: Alan G. Jardine

given: Alan G.

family: Khawaja

full_name: Zeeshan Khawaja

given: Zeeshan

family: Koury

full_name: Mark J. Koury

given: Mark J.

family: Lewis

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Lin

full_name: Tim Lin

given: Tim

family: Luo

full_name: Wenli Luo

given: Wenli

family: Maroni

full_name: Bradley J. Maroni

given: Bradley J.

family: Matsushita

full_name: Kunihiro Matsushita

family: McCullough

full_name: Peter A. McCullough

given: Peter A.

family: Parfrey

full_name: Patrick S. Parfrey

given: Patrick S.

family: Roy-Chaudhury

full_name: Prabir Roy-Chaudhury

given: Prabir

family: Sarnak

full_name: Mark J. Sarnak

family: Sharma

full_name: Amit Sharma

given: Amit

family: Spinowitz

full_name: Bruce Spinowitz

given: Bruce

title: Vadadustat in Patients with Anemia and Non–Dialysis-Dependent CKD

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

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


location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Ukraine
Costa Rica
Croatia
France
Japan
Lithuania
Poland
Canada
Slovenia
Korea, Republic of
Sweden
Hong Kong
Switzerland
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Spain
Turkey

acronym: CREAD

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Queen Mary Hospital, Division of Geriatric Medicine

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med

location_facility: SHI City Psychoneurological Dispensary #7

location_facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Charles University, Medical faculty, Hradec Kralove ;Department of Neurology

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Alexandrovska hospital; Neurology Department

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: University of North Texas Health Science Center; Fort Worth Patient Care Center

location_facility: Szent Borbala Korhaz; Neurologiai es Stroke Osztaly

location_facility: Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Alzheimer's Research and Treatment Center

location_facility: UCLA Medical Center, Department of Neurology

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Osmangazi University School of Medicine,Neurology Department

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Institute for Neurodegenerative Disorders

location_facility: Caulfield Hospital; Aged Psychiatry Research Unit

location_facility: Drexel Univ College of Med; Clinical Research Group

location_facility: Regional mental hospital; Department of psychiatry, psychology and sexology

location_facility: National Clinical Research Inc.-Richmond

location_facility: D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System

location_facility: University of Szeged; Department of Psychiatry

location_facility: Coventry and Warwickshire Partnership NHS Trust

location_facility: Ewha Womans University Mokdong Hospital; Dept of Neurology

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: Neurodegenerative Disorders Research; Neurology

location_facility: Albany Medical Faculty Physicians COmmunity Division. The Neurology Group

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Semmelweis University; Department of Neurology

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: General Teaching Hospital, Departmetn of Neurology

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: Alliance for Wellness, dba Alliance for Research

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Advanced Memory Research Institute of NJ

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Jávorszky Ödön Kórház, Neurológia és stroke osztály

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Jacksonville Center For Clinical Research

location_facility: Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia

location_facility: Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute

location_facility: Hospital Sant Joan de Deu; Servicio de Neurología

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie

location_facility: Hacettepe University School of Medicine; Neurology

location_facility: Konventhospital Barmherzige Brüder; Neurologie I

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: National Center of Neurology and Psychiatry

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1

location_facility: Universitäres Zentrum für Altersmedizin und Rehabilitation

location_facility: Southern Illinois University, School of Medicine

location_facility: Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.

summary: This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.