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An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice
Sponsor: AbbVie
Summary
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Official title: Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
785
Start Date
2022-08-15
Completion Date
2028-03
Last Updated
2025-02-28
Healthy Volunteers
No
Conditions
Locations (153)
Gedyt /ID# 249611
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Britanico de Buenos Aires /ID# 249605
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
Córdoba, Argentina
Blacktown Hospital /ID# 248354
Blacktown, New South Wales, Australia
Nepean Hospital /ID# 248351
Kingswood, New South Wales, Australia
Coral Sea Clinical Research institute /ID# 248352
North Mackay, Queensland, Australia
Austin Health /ID# 249133
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital /ID# 248353
Parkville, Victoria, Australia
University of Calgary /ID# 259183
Calgary, Alberta, Canada
Gastroenterology and Internal Medicine Research Institution /ID# 251463
Edmonton, Alberta, Canada
Dr. J Siffledeen Profess Pract /ID# 256903
Edmonton, Alberta, Canada
Six08 Gastroenterology /ID# 259452
Lethbridge, Alberta, Canada
Dr. Sundeep Singh, Inc /ID# 251471
Kelowna, British Columbia, Canada
The Moncton Hospital /ID# 257337
Moncton, New Brunswick, Canada
Barrie GI Associates /ID# 264978
Barrie, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819
Hamilton, Ontario, Canada
London Health Sciences Center- University Hospital /ID# 258472
London, Ontario, Canada
West GTA Endoscopy /ID# 263221
Mississauga, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 256826
North Bay, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc /ID# 256827
North York, Ontario, Canada
Toronto Digestive Disease Associates /ID# 258914
Vaughan, Ontario, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528
Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 258470
Montreal, Quebec, Canada
Diex Recherche Québec /ID# 262796
Québec, Quebec, Canada
Iscare Klinické Centrum /ID# 259811
Prague, Praha 9, Czechia
SurGal Clinic /ID# 259809
Brno, South Moravian, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 259810
České Budějovice, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 261535
Prague, Czechia
Fakultni Thomayerova nemocnice /ID# 261626
Prague, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 251938
Nice, Alpes-Maritimes, France
APHM - Hopital Nord /ID# 252049
Marseille, Bouches-du-Rhone, France
CHU de Besancon - Jean Minjoz /ID# 252966
Besançon, Doubs, France
CHU NIMES - Hopital Caremeau /ID# 254790
Nîmes, Gard, France
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496
Colmar, Grand Est, France
CHU Toulouse - Hopital Rangueil /ID# 251879
Toulouse, Haute-Garonne, France
CHU Montpellier - Hopital Saint Eloi /ID# 252041
Montpellier, Herault, France
CHU Grenoble - Hopital Michallon /ID# 251937
La Tronche, Isere, France
Clinique Santé Atlantique /ID# 252581
Saint-Herblain, Loire-Atlantique, France
CHU Reims - Hôpital Robert Debre /ID# 252017
Reims, Marne, France
CHRU Lille - Hopital Claude Huriez /ID# 251971
Lille, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 251972
Créteil, Paris, France
AP-HP - Hopital Bicetre /ID# 252329
Le Kremlin-Bicêtre, Paris, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 252265
St-Priest-en-Jarez, Pays de la Loire Region, France
Centre Hospitalier D'Avignon /ID# 252657
Avignon, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Cote Basque /ID# 252358
Bayonne, Pyrenees-Atlantiques, France
HCL - Hopital Lyon Sud /ID# 252093
Pierre-Bénite, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 252103
Amiens, Somme, France
Clinique de l'Europe /ID# 251851
Amiens, Somme, France
Ch Bethune - Beuvry /Id# 252233
Béthune, France
Pole Sante Saint-Jean /ID# 252235
Cagnes-sur-Mer, France
CH Annecy Genevois - Site Annecy /ID# 253010
Epagny Metz Tessy, France
GHI Le Raincy - Montfermeil /ID# 252733
Montfermeil, France
Clinique Jules Verne /ID# 251969
Nantes, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252125
Orléans, France
Institut Mutualiste Montsouris /ID# 251849
Paris, France
CHRU Pontchaillou /ID# 252015
Rennes, France
Centres des maladies de l'appareil digestif /ID# 252283
Strasbourg, France
Clinique Pasteur /ID# 251893
Toulouse, France
Hôpital Schuman /ID# 252995
Vantoux, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565
Neuilly-sur-Seine, Île-de-France Region, France
Medizinisches Versorgunszentrum Dachau /ID# 257231
Dachau, Bavaria, Germany
Praxis Dres. Hurst/Simonis /ID# 255159
Darmstadt, Hesse, Germany
Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224
Frankfurt am Main, Hesse, Germany
Markus Krankenhaus /ID# 260648
Frankfurt am Main, Hesse, Germany
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076
Kassel, Hesse, Germany
Magen-Darm-Zentrum-Remscheid /ID# 250339
Remscheid, North Rhine-Westphalia, Germany
Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824
Saarbrücken, Saarland, Germany
Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873
Leipzig, Saxony, Germany
Private Practice - Dr. Thomas Zeisler /ID# 250126
Halle, Saxony-Anhalt, Germany
Praxis S. Tetzlaff /ID# 248263
Buedelsdorf, Schleswig-Holstein, Germany
Thurman/Bethge /ID# 248305
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273
Lübeck, Schleswig-Holstein, Germany
Praxis fuer Gastroenterologie /ID# 250749
Lübeck, Schleswig-Holstein, Germany
Dr. Bernd Adami /ID# 248123
Alzey, Germany
Dr. Heil /ID# 248273
Andernach, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979
Berlin, Germany
Praxis Dr. Michael Mross /ID# 248272
Berlin, Germany
Krankenhaus Waldfriede /ID# 248307
Berlin-Zehlendorf, Germany
Praxis Dr. Lukas Buendgens & Dr. Burkhard Buendgens /ID# 254873
Eschweiler, Germany
Dres. Bauer/Doerflinger /ID# 252107
Freiburg im Breisgau, Germany
Dres. Behrens/Fechner/Streudel /ID# 250872
Halle, Germany
Miamedes Hausarztpraxis Altona /ID# 260064
Hamburg, Germany
Medizinische Hochschule Hannover /ID# 257454
Hanover, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262
Herne, Germany
Dres. Breitschwerdt/Glas/Gurtler /ID# 251192
Leipzig, Germany
Bettenworth & Partner /ID# 248977
Münster, Germany
Gastro Campus Research GbR /ID# 249867
Münster, Germany
Gastro.Praxis am Meerbachbogen /ID# 251856
Nienburg, Germany
Praxis Dres Brendel /ID# 250559
Nuremberg, Germany
Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581
Remscheid, Germany
Praxis Dr. Kempelmann /ID# 257748
Tostedt, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787
Athens, Attica, Greece
Alexandra General Hospital /ID# 260786
Athens, Attica, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794
Nikaia, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 259869
Heraklion, Crete, Greece
University General Hospital of Alexandroupoli /ID# 270159
Alexandroupoli, Evros, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259870
Athens, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 260785
Thessaloniki, Greece
Connolly Hospital Blanchardstown /ID# 252190
Abbotstown, Dublin, Ireland
St Vincent's University Hospital /ID# 251855
Elm Park, Dublin, Ireland
University Hospital Galway /ID# 253427
Galway, Ireland
Shamir Medical Center /ID# 256885
Beer Ya'akov, Central District, Israel
Rambam Health Care Campus /ID# 249884
Haifa, H_efa, Israel
Soroka University Medical Center /ID# 249885
Beersheba, Southern District, Israel
Tel Aviv Sourasky Medical Center /ID# 250562
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 249474
Petah Tikva, Israel
Ente Ospedaliero Specializzato in Gastroenterologia Saverio de Bellis - IRCCS /ID# 261600
Castellana Grotte, Bari, Italy
IRCCS Istituto Clinico Humanitas /ID# 260801
Rozzano, Lombardy, Italy
IRCCS Ospedale San Raffaele /ID# 261058
Milan, Milano, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 260802
Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260811
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 260946
Rome, Roma, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 261116
Negrar, Verona, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260812
Milan, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261052
Palermo, Italy
Azienda Ospedaliero Universitaria Pisana /ID# 261126
Pisa, Italy
Mubarak Hospital /ID# 252026
Hawalli, Kuwait
Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710
Funchal, Madeira, Portugal
Hospital Garcia de Orta /ID# 264420
Almada, Setúbal District, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517
Faro, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524
Lisbon, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 258759
Lisbon, Portugal
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 272785
Loures, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 260038
Porto, Portugal
Centro Hosp de Tondela-Viseu /ID# 258760
Viseu, Portugal
Hamad Medical Corporation /ID# 253823
Zone 51, Baladīyat ar Rayyān, Qatar
Voronezh Regional Clinical Hospital #1 /ID# 249932
Voronezh, Russia
Hospital Universitari de Bellvitge /ID# 263932
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Parc Tauli /ID# 263931
Sabadell, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263929
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital de Cabueñes /ID# 263930
Gijón, Principality of Asturias, Spain
Hospital Universitario de Canarias /ID# 264214
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario Virgen Macarena /ID# 263924
Seville, Sevilla, Spain
Hospital Universitario Virgen del Rocio /ID# 263926
Seville, Sevilla, Spain
Hospital Galdakao-Usansolo /ID# 263925
Galdakao, Vizcaya, Spain
Hospital Universitario Torrecárdenas /ID# 264202
Almería, Spain
Hospital Juan Ramón Jiménez /ID# 267702
Huelva, Spain
Hospital Universitario de Salamanca /ID# 264207
Salamanca, Spain
Burjeel Day Surgery Center /ID# 252030
Abu Dhabi, United Arab Emirates
Cleveland Clinic Abu Dhabi /ID# 252038
Abu Dhabi, United Arab Emirates
Royal Devon & Exeter Hospital /ID# 252734
Exeter, Devon, United Kingdom
Hull University Teaching Hospitals NHS Trust /ID# 253988
Hull, East Riding Of Yorkshire, United Kingdom
Hampshire Hospitals NHS Foundation Trust /ID# 261416
Basingstoke, Essex, United Kingdom
Northern Care Alliance NHS Foundation Trust /ID# 253993
Bury, Lancashire, United Kingdom
Kettering General Hospital NHS Foundation Trust /ID# 255263
Kettering, Northamptonshire, United Kingdom
Nottingham City Hospital /ID# 255270
Nottingham, Nottinghamshire, United Kingdom
Oxford University Hospitals - John Radcliffe Hospital /ID# 265343
Oxford, Oxfordshire, United Kingdom
Ulster Hospital - South Eastern Health & Social Care Trust /ID# 255265
Belfast, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 253989
Liverpool, United Kingdom
Barts Health NHS Trust /ID# 252735
London, United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 255271
Tooting, United Kingdom
New Cross Hospital /ID# 266364
Wolverhampton, United Kingdom