ReferenceCitation: Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.

family: Zhu

full_name: Dingliang L. Zhu

given: Dingliang L.

family: Bays

full_name: Harold Bays

given: Harold

family: Gao

full_name: Pingjin Gao

given: Pingjin

family: Mattheus

full_name: Michaela Mattheus

given: Michaela

family: Voelker

full_name: Birgit Voelker

given: Birgit

family: Ruilope

full_name: Luis M. Ruilope

given: Luis M.

journal_name: Clinical Therapeutics

title: Efficacy and Tolerability of Initial Therapy With Single-Pill Combination Telmisartan/Hydrochlorothiazide 80/25 mg in Patients With Grade 2 or 3 Hypertension: A Multinational, Randomized, Double-Blind, Active-Controlled Trial

location_country:
France
Bulgaria
Georgia
Romania
Russian Federation
China
United States
Korea, Republic of

location_facility: 502.550.3305G Boehringer Ingelheim Investigational Site

location_facility: 502.550.3306A Boehringer Ingelheim Investigational Site

location_facility: 502.550.40001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35911 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35905 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35904 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302A Boehringer Ingelheim Investigational Site

location_facility: 502.550.40004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305I Boehringer Ingelheim Investigational Site

location_facility: 502.550.40005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01015 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304D Boehringer Ingelheim Investigational Site

location_facility: 502.550.86010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302I Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302G Boehringer Ingelheim Investigational Site

location_facility: 502.550.82011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302B Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301F Boehringer Ingelheim Investigational Site

location_facility: 502.550.99501 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301J Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301H Boehringer Ingelheim Investigational Site

location_facility: 502.550.01004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01016 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3306F Boehringer Ingelheim Investigational Site

location_facility: 502.550.07005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82013 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01020 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302D Boehringer Ingelheim Investigational Site

location_facility: 502.550.99503 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35909 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303D Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303C Boehringer Ingelheim Investigational Site

location_facility: 502.550.40009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99502 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304F Boehringer Ingelheim Investigational Site

location_facility: 502.550.35901 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35906 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01017 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35903 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304A Boehringer Ingelheim Investigational Site

location_facility: 502.550.35902 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01019 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301I Boehringer Ingelheim Investigational Site

location_facility: 502.550.82006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302E Boehringer Ingelheim Investigational Site

location_facility: 502.550.01018 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305A Boehringer Ingelheim Investigational Site

location_facility: 502.550.99507 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99505 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99508 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303A Boehringer Ingelheim Investigational Site

location_facility: 502.550.35908 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35910 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304J Boehringer Ingelheim Investigational Site

location_facility: 502.550.01003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3307A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99506 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301K Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302C Boehringer Ingelheim Investigational Site

location_facility: 502.550.99504 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01014 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303F Boehringer Ingelheim Investigational Site

location_facility: 502.550.01011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301E Boehringer Ingelheim Investigational Site

location_facility: 502.550.07002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40002 Boehringer Ingelheim Investigational Site

title: A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

summary: The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Boehringer Ingelheim

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Sweden
India
Mexico
Netherlands
Croatia
France
Lithuania
Tunisia
Romania
Russian Federation
Estonia
Germany
Canada
Ukraine

location_facility: 1218.52.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38505 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91019 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9991 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91018 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91013 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91015 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91014 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91012 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31015 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2161B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2161A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52009 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9999 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2163B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38504 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9992 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9993 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38503 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38502 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37203 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2162B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3306C Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2162A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37202 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37201 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38501 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91016 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2163A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11010 Boehringer Ingelheim Investigational Site

type: EudraCT Number

source: euctr

title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

summary: A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

summary:
Primary objective:

Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

Compare the following parameters following 4 cycles of VD or VTD induction treatment:

CR rate+ very good partial remission (VGPR) rate
Overall remission rate (CR + VGPR + partial remission (PR) rate)
K/l light chain ratio in patients in CR.
Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).

status: Unknown status

ReferenceType: derived

ReferenceCitation: Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pégourié B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traullé C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.

family: Moreau

full_name: Philippe Moreau

given: Philippe

sequence: first

family: Avet-Loiseau

full_name: Herve Avet-Loiseau

given: Herve

sequence: additional

family: Facon

full_name: Thierry Facon

given: Thierry

family: Attal

full_name: Michel Attal

given: Michel

name: General Hospital, La Roche-sur-Yon, France;

family: Tiab

full_name: Mourad Tiab

given: Mourad

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Doyen

full_name: Chantal Doyen

given: Chantal

name: University Hospital Saint-Antoine, Paris, France;

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Randriamalala

full_name: Edouard Randriamalala

given: Edouard

family: Araujo

full_name: Carla Araujo

given: Carla

family: Lepeu

full_name: Gérard Lepeu

given: Gérard

family: Marit

full_name: Gerald Marit

given: Gerald

family: Caillot

full_name: Denis Caillot

given: Denis

family: Escoffre

full_name: Martine Escoffre

given: Martine

name: University Hospital, Strasbourg, France;

family: Lioure

full_name: Bruno Lioure

given: Bruno

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Pégourié

full_name: Brigitte Pégourié

given: Brigitte

family: Kolb

full_name: Brigitte Kolb

name: Institut Paoli-Calmettes, Marseille, France;

family: Stoppa

full_name: Anne Marie Stoppa

given: Anne Marie

family: Fuzibet

full_name: Jean-Gabriel Fuzibet

given: Jean-Gabriel

family: Decaux

full_name: Olivier Decaux

given: Olivier

family: Dib

full_name: Mamoun Dib

given: Mamoun

family: Berthou

full_name: Christian Berthou

given: Christian

name: University Hospital, Clermont-Ferrand, France;

family: Chaleteix

full_name: Carine Chaleteix

name: Centre René Gauducheau, Nantes/St Herblain, France

location_facility:
Bruxelles I Bordet
CHR Metz Bonsecours
CHU Rennes M interne
CHU Clermont Ferrand
CHU Lyon Sud Pierre Benite
Bobigny Avicenne
Ch Colmar
Bruxelles Erasme
CHU Poitiers hemato
CH BLOIS
CH Chartres
Chru Lille
Chu Bordeaux
Le Mans Victor Hugo
Chu Angers
St ETIENNE
CH Bayonne
CHU Reims
Chu Nantes
CHU Nice M Interne
Paris Necker
CHU Rennes Hemato
Nantes Catherine De Sienne
CH La Roche Sur Yon
GILLY
Ch Lorient
CHU Lyon Edouard Herriot
Paris Hôtel Dieu
CH Vannes
Caen M Interne Baclèse
CH Annecy
Chu Grenoble
Chu Besancon
Paris St Louis
ANVERS Centrumziekenhuis
Marseille IPC
Rouen Becquerel
CH Roanne
BRUXELLES St LUC
YVOIR MontGodinne
Chu Nancy
Chu Brest
Lyon Léon Berard
Ch Avignon
Anvers Uza
Chu Dijon
Paris St Antoine
CHR Orléans
CH St Brieuc
Ch Dunkerque
CHRU Strasbourg
Chu Toulouse
CHU Tours
Clamart Percy
CH Valence
Paris Cochin


title: ARI103094-Follow-Up Study for REDUCE Study Subjects

summary:
ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B:

REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study. Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as follows: (1) REDUCE subjects who completed treatment with investigational product (dutasteride or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit 10). The objective of this observational study for eligible REDUCE subjects is to collect and summarize data on prostate cancer (the incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled study, REDUCE.
REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE study.

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Grubb RL, Andriole GL, Somerville MC, Mahoney C, Manyak MJ, Castro R. The REDUCE Follow-Up Study: low rate of new prostate cancer diagnoses observed during a 2-year, observational, followup study of men who participated in the REDUCE trial. J Urol. 2013 Mar;189(3):871-7. doi: 10.1016/j.juro.2012.09.099. Epub 2012 Sep 25.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Chile
Sweden
Netherlands
Germany
Finland
France
Greece
Argentina
Spain
Canada
United Kingdom


title: An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.

summary: This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was > 500 individuals.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Saudi Arabia
United Kingdom
Netherlands
Spain
France
Poland
Greece
Romania
Hungary
Australia
Portugal
Canada
Czech Republic


type: Other Identifier

title: A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

acronym: BEACON CRC

summary: This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.

name: Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain

family: Tabernero

full_name: Josep Tabernero

given: Josep

name: West Cancer Center, OneOncology, Germantown, TN

family: Grothey

full_name: Axel Grothey

given: Axel

name: University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

name: Memorial Sloan-Kettering Cancer Center, New York, NY

family: Yaeger

full_name: Rona Yaeger

given: Rona

name: Hammersmith Hospital, Department of Cancer Medicine, Imperial College London, London, United Kingdom

family: Wasan

full_name: Harpreet Wasan

given: Harpreet

name: National Cancer Center Hospital East, Kashiwa, Japan

family: Yoshino

full_name: Takayuki Yoshino

given: Takayuki

name: Royal Melbourne Hospital and Peter MacCallum Cancer Centre, Walter and Aliza Hall Institute, Parkville, Australia

family: Desai

full_name: Jayesh Desai

given: Jayesh

family: Ciardiello

full_name: Fortunato Ciardiello

given: Fortunato

name: Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy

family: Loupakis

full_name: Fotios Loupakis

given: Fotios

family: Hong

full_name: Yong Sang Hong

given: Yong Sang

name: Netherlands Cancer Institute, Amsterdam, the Netherlands

family: Steeghs

full_name: Neeltje Steeghs

given: Neeltje

family: Guren

full_name: Tormod Kyrre Guren

given: Tormod Kyrre

name: Sarah Cannon Research Institute, UCL Cancer Institute, University College London, London, United Kingdom

family: Arkenau

full_name: Hendrik-Tobias Arkenau

given: Hendrik-Tobias

name: Hospital Gregorio Maranon, Madrid, Spain

family: Garcia-Alfonso

full_name: Pilar Garcia-Alfonso

given: Pilar

family: Elez

full_name: Elena Elez

given: Elena

family: Gollerkeri

full_name: Ashwin Gollerkeri

given: Ashwin

family: Maharry

full_name: Kati Maharry

given: Kati

family: Christy-Bittel

full_name: Janna Christy-Bittel

given: Janna

name: The University of Texas MD Anderson Cancer Center, Houston, TX

family: Kopetz

full_name: Scott Kopetz

given: Scott

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

repository_institution: University College London - UCL Discovery

repositories_institution: University College London - UCL Discovery

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E–Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study

ReferenceCitation: Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. doi: 10.1056/NEJMoa1908075. Epub 2019 Sep 30.

name: From the University of Texas M.D. Anderson Cancer Center, Houston (S.K., V.M.); West Cancer Center and Research Institute, OneOncology, Germantown, TN (A. Grothey); Memorial Sloan Kettering Cancer Center, New York (R.Y., A.K.); University Hospital Gasthuisberg and University of Leuven, Leuven, Belgium (E.V.C., J. Dekervel); the Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (J. Desai, C.G.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); Hammersmith Hospital, Division of Cancer,...

title: Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer

ReferenceCitation: Van Cutsem E, Huijberts S, Grothey A, Yaeger R, Cuyle PJ, Elez E, Fakih M, Montagut C, Peeters M, Yoshino T, Wasan H, Desai J, Ciardiello F, Gollerkeri A, Christy-Bittel J, Maharry K, Sandor V, Schellens JHM, Kopetz S, Tabernero J. Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study. J Clin Oncol. 2019 Jun 10;37(17):1460-1469. doi: 10.1200/JCO.18.02459. Epub 2019 Mar 20.

name: Memorial Sloan Kettering Cancer Center, New York, NY

name: Imelda General Hospital, Bonheiden, Belgium; University Hospitals Gasthuisberg, Leuven, Belgium

name: Vall d’Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain

name: City of Hope Comprehensive Cancer Center, Duarte, CA

name: Hospital del Mar–Institut Hospital del Mar d'Investigacions Mèdiques, Universitat Pompeu Fabra, Barcelona, Spain

name: Antwerp University Hospital, Edegem, Belgium

name: Hammersmith Hospital, Imperial College London, London, United Kingdom

name: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

name: University of Campania “Luigi Vanvitelli,” Naples, Italy

name: Utrecht University, Utrecht, the Netherlands

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

title: Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E–Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study

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:
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Inonu Universitesi Turgut Ozal Medical Center

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location_facility: Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Augenheilkunde und Optometrie

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location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oftalmologia Diagnostica de Sorocaba (ODS)

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location_facility: Centre Ophtalmologique - Pole Vision - Clinique Val d'Ouest

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location_facility: Pharmacy of Rabin Medical Center, Beilinson Hospital

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

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location_facility: Centro Medico CAIPO (Centro para la Atención del paciente Oncológico)

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location_facility: TOV "Zakarpatskyi Tsentr Mikrokhirurhii Oka"

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location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

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location_facility: U.O.S.D. Patologie Retiniche - Fondazione PTV Policlinico Tor Vergata

location_facility: Keck Hospital of USC - Norris Healthcare Center (HC3)

location_facility: Medical Oncology Associates, PS DBA Summit Cancer Centers


intervention_type: Biological

location_country:
Italy
Sweden
Switzerland
Netherlands
Finland
France
Czechia
Norway
Ireland
Belgium
Australia
Spain
Estonia
Denmark
Germany
United Kingdom
Turkey

acronym: CASTING

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

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location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Cork University Hospital; Clinical Research Facility

location_facility: MultipEL Studies - Institut für klinische Studien

location_facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

location_facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

location_facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

location_facility: PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: East Tallinn Central Hospital; Neurology Department

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Neurologische Klinik, Universitätsklinikum Heidelberg

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Klinikum Grosshadern der LMU; Neuroimmunologie II

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie

location_facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

location_facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

location_facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

location_facility: Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie

location_facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito

location_facility: Universitätsspital Basel; Neurologische Poliklinik

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie

location_facility: Hôpitaux Universitaires de strasbourg - hôpital civil

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

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

location_facility: Hospital Universitario Central de Asturias; Servicio de Neurología

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie

location_facility: Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

location_facility: St. Josefs-Krankenhaus, Klinik für Neurologie

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: Odense Universitetshospital, Neurologisk Afdeling N

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

title: An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

summary: The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.


title: A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

acronym: CASCADE

summary: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

status: Terminated

lead_sponsor: Seagen Inc.

location_country:
Italy
Austria
Luxembourg
Germany
France
Czechia
Poland
Israel
Hungary
Australia
Belgium
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: Shands Cancer Center / University of Florida

location_facility: Centre Hospitalier Victor Dupouy d'Argenteuil

location_facility: Centre Hospitalier Luxembourg - CHL Centre

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Soroka Medical Center, Dept. of Oncology

location_facility: University of Arkansas for Medical Sciences

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Virginia Commonwealth University Medical Center

location_facility: Florida Cancer Specialists - North Region

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: County Durham and Darlington NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: LSU Health Sciences Center / Feist Weiller Cancer Center

location_facility: Debreceni Egyetem Orvos Ã©s Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Florida Center for Cellular Therapy / Blood and Marrow Transplant Center

location_facility: Florida Cancer Specialists - South Region

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

location_facility: Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan

location_facility: Intermountain Blood and Marrow Transplant/Acute Leukemia Program

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire Hopital Avicenne

location_facility: Hopital d'Instruction des Armees - Percy

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: Centre Hospitalier Universitaire Sart Tilman Liege

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: Keimyung University Dongsan Medical Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

status_simplified: Unknown


title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

summary:
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

lead_sponsor: Celgene

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
Croatia
France
Poland
Slovakia
Norway
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Spain
Turkey
Latvia

location_facility: Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Ternopil City Communal Emergency Medical Care Hospital

location_facility: RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

location_facility: Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

location_facility: Azienda Ospedaliera Universitaria Policlinico G Martino

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

location_facility: CHA Bundang Medical Center CHA University

location_facility: Gastroenterology Associates of Western Michigan PLC

location_facility: Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Indywidualna Praktyka Lekarska Maciej Zymla

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: SBHI of NN region RCH of NN n.a. N.A.Semashko

location_facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

location_facility: Via Christi Research a division of Via Christi Hospitals Wichita Inc

location_facility: University General Hospital of Alexandroupolis

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Severance Hospital, Yonsei University Health System

location_facility: London Health Science Center U. Hospital

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Toronto Digestive Disease Associates Inc

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: McMaster University Health Sciences Center

location_facility: Yeditepe University Medical School Hospital

location_facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

location_facility: Seoul National University Bundang Hospital

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: McGill University Health Centre Glen Site Royal Victoria Hospital

location_facility: Nottingham University Hospitals Queens Medical Centre

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: University of Texas Health Science Center at Houston

location_facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

location_facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: Centre de sante et de services sociaux Champlain Charles Le Moyne

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: University of Washington School of Medicine

location_facility: Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Clinical Research Institute of Michigan, LLC

intervention_type: Other


publications_result: Foster GR, Thompson AJ, Ruane PJ, Borgia SM, Dore G, Workowski K, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study [Abstract 258]. J Hepatology 2016;63 (1S):135A

ReferenceType: result

ReferenceCitation: Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Bräu N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.

family: Jacobson

full_name: Ira M. Jacobson

given: Ira M.

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Gane

full_name: Edward J. Gane

given: Edward J.

family: Willems

full_name: Bernard E. Willems

given: Bernard E.

family: Ruane

full_name: Peter J. Ruane

given: Peter J.

family: Nahass

full_name: Ronald G. Nahass

given: Ronald G.

family: Borgia

full_name: Sergio M. Borgia

given: Sergio M.

family: Shafran

full_name: Stephen D. Shafran

given: Stephen D.

family: Workowski

full_name: Kimberly A. Workowski

given: Kimberly A.

family: Pearlman

full_name: Brian Pearlman

given: Brian

family: Hyland

full_name: Robert H. Hyland

given: Robert H.

family: Stamm

full_name: Luisa M. Stamm

given: Luisa M.

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Dvory-Sobol

full_name: Hadas Dvory-Sobol

given: Hadas

family: Zhu

full_name: Yanni Zhu

given: Yanni

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Bräu

full_name: Norbert Bräu

given: Norbert

family: Berg

full_name: Thomas Berg

given: Thomas

family: Agarwal

full_name: Kosh Agarwal

given: Kosh

family: Bhandari

full_name: Bal Raj Bhandari

given: Bal Raj

family: Davis

full_name: Mitchell Davis

given: Mitchell

family: Feld

full_name: Jordan J. Feld

given: Jordan J.

family: Dore

full_name: Gregory J. Dore

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

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

location_country:
United States
Germany
France
Australia
Puerto Rico
New Zealand
Canada
United Kingdom

title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

summary: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.


ReferenceCitation: Cutter G, Veneziano A, Grinspan A, Al-Banna M, Boyko A, Zakharova M, Maida E, Pasic MB, Gandhi SK, Everts R, Cordioli C, Rossi S. Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS. Mult Scler Relat Disord. 2019 Aug;33:13-21. doi: 10.1016/j.msard.2019.04.036. Epub 2019 May 9.

family: Cutter

full_name: Gary Cutter

given: Gary

family: Veneziano

full_name: Antonella Veneziano

given: Antonella

family: Grinspan

full_name: Augusto Grinspan

given: Augusto

family: Al-Banna

full_name: Mahir Al-Banna

given: Mahir

family: Boyko

full_name: Alexey Boyko

given: Alexey

family: Zakharova

full_name: Maria Zakharova

given: Maria

family: Maida

full_name: Eva Maida

given: Eva

family: Pasic

full_name: Marija Bosnjak Pasic

given: Marija Bosnjak

family: Gandhi

full_name: Sanjay K. Gandhi

given: Sanjay K.

family: Everts

full_name: Robin Everts

given: Robin

family: Cordioli

full_name: Cinzia Cordioli

given: Cinzia

family: Rossi

full_name: Silvia Rossi

given: Silvia

journal_name: Multiple Sclerosis and Related Disorders

oa_host_type: publisher

evidence: open (via crossref license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Teva Pharmaceutical Industries, Ltd.

location_country:
Italy
Austria
Mexico
Spain
Germany
Finland
Croatia
France
Poland
Ireland
Argentina
Belgium
Puerto Rico
Russian Federation
Turkey
United States

acronym: CONFIDENCE

location_facility:
Teva Investigational Site 13476
Teva Investigational Site 13470
Teva Investigational Site 35202
Teva Investigational Site 53348
Teva Investigational Site 50390
Teva Investigational Site 20061
Teva Investigational Site 35205
Teva Investigational Site 35214
Teva Investigational Site 13487
Teva Investigational Site 32603
Teva Investigational Site 30162
Teva Investigational Site 21097
Teva Investigational Site 13475
Teva Investigational Site 53346
Teva Investigational Site 82052
Teva Investigational Site 21098
Teva Investigational Site 13471
Teva Investigational Site 30167
Teva Investigational Site 53354
Teva Investigational Site 35207
Teva Investigational Site 13473
Teva Investigational Site 35201
Teva Investigational Site 30161
Teva Investigational Site 32604
Teva Investigational Site 50376
Teva Investigational Site 50392
Teva Investigational Site 53353
Teva Investigational Site 20062
Teva Investigational Site 60039
Teva Investigational Site 35212
Teva Investigational Site 50375
Teva Investigational Site 30164
Teva Investigational Site 37063
Teva Investigational Site 53350
Teva Investigational Site 40014
Teva Investigational Site 31179
Teva Investigational Site 60034
Teva Investigational Site 31182
Teva Investigational Site 82050
Teva Investigational Site 50377
Teva Investigational Site 53352
Teva Investigational Site 32605
Teva Investigational Site 53345
Teva Investigational Site 53351
Teva Investigational Site 31177
Teva Investigational Site 50378
Teva Investigational Site 35203
Teva Investigational Site 13524
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title: CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily

summary: The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.


title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

acronym: CheckMate 227

summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.

family: Reck

full_name: Martin Reck

given: Martin

family: Ciuleanu

full_name: Tudor-Eliade Ciuleanu

given: Tudor-Eliade

family: Lee

full_name: Jong-Seok Lee

given: Jong-Seok

family: Schenker

full_name: Michael Schenker

given: Michael

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Zurawski

full_name: Bogdan Zurawski

given: Bogdan

family: Linardou

full_name: Helena Linardou

given: Helena

family: Otterson

full_name: Gregory A. Otterson

given: Gregory A.

family: Salman

full_name: Pamela Salman

given: Pamela

family: Nishio

full_name: Makoto Nishio

given: Makoto

family: de la Mora Jimenez

full_name: Emmanuel de la Mora Jimenez

given: Emmanuel

family: Lesniewski-Kmak

full_name: Krysztof Lesniewski-Kmak

given: Krysztof

family: Albert

full_name: István Albert

given: István

family: Ahmed

full_name: Samreen Ahmed

given: Samreen

family: Syrigos

full_name: Konstantinos Syrigos

given: Konstantinos

family: Penrod

full_name: John R. Penrod

given: John R.

family: Yuan

full_name: Yong Yuan

given: Yong

family: Blum

full_name: Steven I. Blum

given: Steven I.

family: Nathan

full_name: Faith E. Nathan

given: Faith E.

family: Sun

full_name: Xiaowu Sun

given: Xiaowu

family: Moreno-Koehler

full_name: Alejandro Moreno-Koehler

given: Alejandro

family: Taylor

full_name: Fiona Taylor

given: Fiona

family: O'Byrne

full_name: Kenneth John O'Byrne

ReferenceCitation: Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.

name: From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology–Germans Trias i Pujol Hospital, Badalona (E.C.C.) — all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and...

title: Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer

ReferenceCitation: Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.

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

title: Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non–small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial

ReferenceCitation: Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.

name: From Memorial Sloan Kettering Cancer Center Hospital, New York (M.D.H.); Prof. Dr. Ion Chiricuta Institute of Oncology and Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj-Napoca, Romania (T.-E.C.); Centrum Onkologii–Instytut im. Marii Sklodowskiej-Curie, Warsaw, Poland (A.P.); Seoul National University Bundang Hospital, Seoul, South Korea (J.S.L.); Ohio State University, Columbus (G.A.O.); Hôpital Sainte Musse, Toulon, France (C.A.-V.); Ospedale Santa Maria della Misericordia, Perugia, Italy ...

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
United Arab Emirates
Saudi Arabia
Switzerland
Netherlands
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Universite Laval

location_facility: Phylasis Clinicas Research S de R. L. de C. V.

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: Klinika Nowotworow Pluca i Klatki Piersiowej

location_facility: Centro Internacional de Estudios Clinicos

location_facility: University Of Texas Southwestern Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Centrum Onkologii-Inst.Im.M.Sklodowskiej-Curie O.W Gliwicach

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Clinica Privada Universitaria Reina Fabiola

location_facility: Clinica San Felipe- Unidad de Oncologia Medica

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Washington University School Of Medicine

location_facility: Hospital Privado Centro Medico De Cordoba

location_facility: ORTHOS Szpital Wielospecjalistyczny Sp. z o.o.

location_facility: Instituto Nacional De Enfermedades Neoplasicas

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Universitaetsklinikum Magdeburg A. o. R.

location_facility: Stadtisches Krankenhaus Martha Maria Halle-Dolau

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

location_facility: Huntsman Cancer Institute At The Univ. Of Utah

location_facility: Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep

location_facility: Oddzial Onkologii I Radioterapii Szpital Morski Im. Pck

location_facility: Administradora Del Country S.A. - Clinica Del Country


title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

summary: The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

ReferenceCitation: Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9:CD011612. doi: 10.1002/14651858.CD011612.pub3. Review.

name: Oxford Health NHS Foundation Trust; Oxford UK

family: Dean

full_name: Rebecca L Dean

given: Rebecca L

family: Hurducas

full_name: Claudia Hurducas

given: Claudia

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

name: Department of Rehabilitation Sciences, Faculty of Health Sciences; Cyprus University of Technology; Lemesos Cyprus

family: Spyridi

full_name: Styliani Spyridi

given: Styliani

family: Cowen

full_name: Philip J Cowen

given: Philip J

family: Hollingsworth

full_name: Sarah Hollingsworth

given: Sarah

family: Marquardt

full_name: Tahnee Marquardt

given: Tahnee

family: Barnes

full_name: Annabelle Barnes

given: Annabelle

family: Smith

full_name: Rebecca Smith

given: Rebecca

family: McShane

full_name: Rupert McShane

given: Rupert

name: Portland Veterans Affairs Medical Center; P3MHDC; Portland USA

name: Department of Psychiatry; Oregon Health & Science University; Portland Oregon USA

family: Turner

full_name: Erick H Turner

given: Erick H

family: Cipriani

full_name: Andrea Cipriani

given: Andrea

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Turkoz I, Daly E, Singh J, Lin X, Tymofyeyev Y, Williamson D, Salvadore G, Nash AI, Macaluso M, Wilkinson ST, Nelson JC. Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response: A Pooled Post Hoc Analysis of the TRANSFORM Studies. J Clin Psychiatry. 2021 Jul 20;82(4). pii: 20m13800. doi: 10.4088/JCP.20m13800.

family: Turkoz

full_name: Ibrahim Turkoz

given: Ibrahim

family: Daly

full_name: Ella Daly

given: Ella

family: Singh

full_name: Jaskaran Singh

given: Jaskaran

family: Lin

full_name: Xiwu Lin

given: Xiwu

family: Tymofyeyev

full_name: Yevgen Tymofyeyev

given: Yevgen

family: Williamson

full_name: David Williamson

given: David

family: Salvadore

full_name: Giacomo Salvadore

given: Giacomo

family: Nash

full_name: Abigail I. Nash

given: Abigail I.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

ReferenceCitation: Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

name: Janssen Research & Development, LLC Raritan New Jersey USA

name: Janssen Research & Development, LLC Titusville New Jersey USA

name: Former employee of Janssen Research and Development, LLC Titusville New Jersey USA

name: Janssen Research & Development, LLC San Diego California USA

name: Neurocrine Biosciences San Diego California USA

title: Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression

ReferenceCitation: Saad Z, Hibar D, Fedgchin M, Popova V, Furey ML, Singh JB, Kolb H, Drevets WC, Chen G. Effects of Mu-Opiate Receptor Gene Polymorphism rs1799971 (A118G) on the Antidepressant and Dissociation Responses in Esketamine Nasal Spray Clinical Trials. Int J Neuropsychopharmacol. 2020 Dec 3;23(9):549-558. doi: 10.1093/ijnp/pyaa030.

name: Janssen Research & Development, San Diego, California

name: Genentech, Inc, South San Francisco, California

name: Janssen Research & Development, Titusville, New Jersey

name: Janssen Research & Development, Beerse, Belgium

journal_name: International Journal of Neuropsychopharmacology

ReferenceCitation: Fedgchin M, Trivedi M, Daly EJ, Melkote R, Lane R, Lim P, Vitagliano D, Blier P, Fava M, Liebowitz M, Ravindran A, Gaillard R, Ameele HVD, Preskorn S, Manji H, Hough D, Drevets WC, Singh JB. Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019 Oct 1;22(10):616-630. doi: 10.1093/ijnp/pyz039.

name: Janssen Research and Development, Department of Neuroscience, Titusville, New Jersey

name: University of Texas Southwestern Medical Center, Department of Psychiatry, Dallas, Texas

name: Janssen Research and Development, Clinical Biostatistics, Titusville, New Jersey

name: University of Ottawa, Departments of Psychiatry and Cellular & Molecular Medicine, Ottawa, Ontario, Canada

name: Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, Massachusetts

name: The Medical Research Network, LLC, New York, New York

name: Institute of Medical Sciences, University of Toronto, Department of Psychiatry, Toronto, Ontario, Canada

name: Centre Hospitalier Sainte Anne, Service Hospitalo-Universitaire, Paris, France

name: AZ Sint-Jan Brugge-Oostende, Department of Psychiatry, Brugge, Belgium

name: University of Kansas School of Medicine-Wichita, Wichita, Kansas

name: Janssen Research and Development, Department of Neuroscience, San Diego, California

location_country:
Brazil
United States
Mexico
France
Slovakia
Hungary
Belgium
Estonia
Canada