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
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT05494606
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 785
- Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
- Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
- Participants prescribed upadacitinib in accordance with the approved local label.
- Participants able to understand and communicate with the investigator and comply with the requirements of the study.
- Participants willing to continue with study documentation after cessation of upadacitinib.
- Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).
- Participants with any contraindication to upadacitinib.
- Participants previously exposed to upadacitinib in a clinical trial.
- Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Response (CR) per Partial Adapted Mayo Score Among those who Achieved CR at Completion of Upadacitinib Induction (either at Week 8 or at Week 16) Week 52 Clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1.
Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score Up to approximately week 156 The first clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1. Median time to achieve the first CR per partial adapted mayo score will be reported
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (153)
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, Lombardia, 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
CHU NIMES - Hopital Caremeau /ID# 254790
🇫🇷Nimes CEDEX 9, Gard, France
Praxis Dres. Hurst/Simonis /ID# 255159
🇩🇪Darmstadt, Hessen, Germany
Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581
🇩🇪Remscheid, Germany
Chu de Nice-Hopital L'Archet Ii /Id# 251938
🇫🇷Nice, Alpes-Maritimes, France
APHM - Hopital Nord /ID# 252049
🇫🇷Marseille, Bouches-du-Rhone, France
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496
🇫🇷Colmar CEDEX, Grand-Est, France
CHU Toulouse - Hopital Rangueil /ID# 251879
🇫🇷Toulouse, Haute-Garonne, France
CHU Montpellier - Hopital Saint Eloi /ID# 252041
🇫🇷Montpellier Cedex 5, Herault, France
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794
🇬🇷Nikaia, Attiki, Greece
University General Hospital of Alexandroupoli /ID# 270159
🇬🇷Alexandroupoli, Evros, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 259869
🇬🇷Heraklion, Kriti, 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
Rambam Health Care Campus /ID# 249884
🇮🇱Haifa, H_efa, Israel
Soroka University Medical Center /ID# 249885
🇮🇱Be'er Sheva, HaDarom, Israel
Shamir Medical Center /ID# 256885
🇮🇱Beer Ya'akov, HaMerkaz, Israel
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
🇮🇹Milano, 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
CHU de Besancon - Jean Minjoz /ID# 252966
🇫🇷Besancon, Doubs, France
Praxis Dr. Kempelmann /ID# 257748
🇩🇪Tostedt, Germany
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517
🇵🇹Faro, Portugal
Gedyt /ID# 249611
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Hospital Britanico de Buenos Aires /ID# 249605
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
🇦🇷Cordoba, 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
SurGal Clinic /ID# 259809
🇨🇿Brno, Jihomoravsky Kraj, Czechia
Iscare Klinické Centrum /ID# 259811
🇨🇿Prague, Praha 9, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 259810
🇨🇿Ceske Budejovice, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 261535
🇨🇿Praha, Czechia
Fakultni Thomayerova nemocnice /ID# 261626
🇨🇿Praha, Czechia
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565
🇫🇷Neuilly Sur Seine, Ile-de-France, France
CHU Grenoble - Hopital Michallon /ID# 251937
🇫🇷La Tronche, Isere, France
Clinique Santé Atlantique /ID# 252581
🇫🇷St Herblain CEDEX, Loire-Atlantique, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 252265
🇫🇷St-Priest-en-Jarez, Loire, France
CHU Reims - Hôpital Robert Debre /ID# 252017
🇫🇷Reims CEDEX, Marne, France
CHRU Lille - Hopital Claude Huriez /ID# 251971
🇫🇷Lille, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 251972
🇫🇷Creteil, Paris, France
AP-HP - Hopital Bicetre /ID# 252329
🇫🇷Le Kremlin Bicetre, Paris, France
Centre Hospitalier D'Avignon /ID# 252657
🇫🇷Avignon, Provence-Alpes-Cote-d Azur, France
Centre Hospitalier de la Cote Basque /ID# 252358
🇫🇷Bayonne, Pyrenees-Atlantiques, France
HCL - Hopital Lyon Sud /ID# 252093
🇫🇷Pierre Benite CEDEX, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 252103
🇫🇷Amiens CEDEX 1, Somme, France
Clinique de l'Europe /ID# 251851
🇫🇷Amiens, Somme, France
Ch Bethune - Beuvry /Id# 252233
🇫🇷Bethune CEDEX, 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 CEDEX 3, France
Hôpital Schuman /ID# 252995
🇫🇷Vantoux, France
Medizinisches Versorgunszentrum Dachau /ID# 257231
🇩🇪Dachau, Bayern, Germany
Markus Krankenhaus /ID# 260648
🇩🇪Frankfurt am Main, Hessen, Germany
Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224
🇩🇪Frankfurt, Hessen, Germany
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076
🇩🇪Kassel, Hessen, Germany
Magen-Darm-Zentrum-Remscheid /ID# 250339
🇩🇪Remscheid, Nordrhein-Westfalen, Germany
Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158
🇩🇪Ludwigshafen am Rhein, Rheinland-Pfalz, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824
🇩🇪Saarbrücken, Saarland, Germany
Private Practice - Dr. Thomas Zeisler /ID# 250126
🇩🇪Halle, Sachsen-Anhalt, Germany
Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873
🇩🇪Leipzig, Sachsen, Germany
Praxis S. Tetzlaff /ID# 248263
🇩🇪Büdelsdorf, 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
Krankenhaus Waldfriede /ID# 248307
🇩🇪Berlin-Zehlendorf, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979
🇩🇪Berlin, Germany
Praxis Dr. Michael Mross /ID# 248272
🇩🇪Berlin, 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 (Saale), Germany
Miamedes Hausarztpraxis Altona /ID# 260064
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover /ID# 257454
🇩🇪Hannover, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262
🇩🇪Herne, Germany
Dres. Breitschwerdt/Glas/Gurtler /ID# 251192
🇩🇪Leipzig, Germany
Gastro Campus Research GbR /ID# 249867
🇩🇪Muenster, Germany
Bettenworth & Partner /ID# 248977
🇩🇪Münster, Germany
Gastro.Praxis am Meerbachbogen /ID# 251856
🇩🇪Nienburg (Weser), Germany
Praxis Dres Brendel /ID# 250559
🇩🇪Nuernberg, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787
🇬🇷Athens, Attiki, Greece
Alexandra General Hospital /ID# 260786
🇬🇷Athens, Attiki, Greece
Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710
🇵🇹Funchal, Regiao Autonoma Da Madeira, Portugal
Hospital Garcia de Orta /ID# 264420
🇵🇹Almada, Setubal, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524
🇵🇹Lisboa, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 258759
🇵🇹Lisboa, 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, Ar Rayyan, Qatar
Voronezh Regional Clinical Hospital #1 /ID# 249932
🇷🇺Voronezh, Russian Federation
Hospital de Cabueñes /ID# 263930
🇪🇸Gijón, Asturias, Spain
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 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