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

Active, not recruiting

• 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

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-08-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 785

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

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