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

NCT05494606 | Active Not Recruiting

• 1 other identifier: P22-921
• Study Type: observational
• Target: 785
• Locations: 17 countries
• Sites: 153

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Upadacitinib; PROFUNDUS; RINVOQ

Outcome Measures

Primary Outcomes (2)

• Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score

  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

  Up to approximately week 156

• 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)

  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.

  Week 52

Study Arms (1)

Participants receiving upadacitinib

Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderately to severely active Ulcerative colitis (UC)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (153)

Gedyt /ID# 249611

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1115, Argentina

Location

Hospital Britanico de Buenos Aires /ID# 249605

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1280, Argentina

Location

Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612

Córdoba, 5016, Argentina

Location

Blacktown Hospital /ID# 248354

Blacktown, New South Wales, 2148, Australia

Location

Nepean Hospital /ID# 248351

Kingswood, New South Wales, 2747, Australia

Location

Coral Sea Clinical Research institute /ID# 248352

North Mackay, Queensland, 4740, Australia

Location

Austin Health /ID# 249133

Heidelberg, Victoria, 3084, Australia

Location

The Royal Melbourne Hospital /ID# 248353

Parkville, Victoria, 3050, Australia

Location

University of Calgary /ID# 259183

Calgary, Alberta, T2N 4Z6, Canada

Location

Gastroenterology and Internal Medicine Research Institution /ID# 251463

Edmonton, Alberta, T5R 1W2, Canada

Location

Dr. J Siffledeen Profess Pract /ID# 256903

Edmonton, Alberta, T6L 6K3, Canada

Location

Six08 Gastroenterology /ID# 259452

Lethbridge, Alberta, T1J 4G9, Canada

Location

Dr. Sundeep Singh, Inc /ID# 251471

Kelowna, British Columbia, V1Y 6J6, Canada

Location

The Moncton Hospital /ID# 257337

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Barrie GI Associates /ID# 264978

Barrie, Ontario, L4M 7G1, Canada

Location

Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819

Hamilton, Ontario, L8S 4K1, Canada

Location

London Health Sciences Center- University Hospital /ID# 258472

London, Ontario, N6A 5W9, Canada

Location

West GTA Endoscopy /ID# 263221

Mississauga, Ontario, L5M 2S4, Canada

Location

Scott Shulman Medicine Professional Corporation /ID# 256826

North Bay, Ontario, P1B 2H3, Canada

Location

Toronto Immune and Digestive Health Institute Inc /ID# 256827

North York, Ontario, M6A 3B4, Canada

Location

Toronto Digestive Disease Associates /ID# 258914

Vaughan, Ontario, L4L 4Y7, Canada

Location

CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528

Montreal, Quebec, H1T 2M4, Canada

Location

Royal Victoria Hospital / McGill University Health Centre /ID# 258470

Montreal, Quebec, H4A 3J1, Canada

Location

Diex Recherche Québec /ID# 262796

Québec, Quebec, G1V 4T3, Canada

Location

Iscare Klinické Centrum /ID# 259811

Prague, Praha 9, 190 00, Czechia

Location

SurGal Clinic /ID# 259809

Brno, South Moravian, 602 00, Czechia

Location

Nemocnice Ceske Budejovice a.s. /ID# 259810

České Budějovice, 370 01, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady /ID# 261535

Prague, 100 34, Czechia

Location

Fakultni Thomayerova nemocnice /ID# 261626

Prague, 140 59, Czechia

Location

Chu de Nice-Hopital L'Archet Ii /Id# 251938

Nice, Alpes-Maritimes, 06202, France

Location

APHM - Hopital Nord /ID# 252049

Marseille, Bouches-du-Rhone, 13015, France

Location

CHU de Besancon - Jean Minjoz /ID# 252966

Besançon, Doubs, 25030, France

Location

CHU NIMES - Hopital Caremeau /ID# 254790

Nîmes, Gard, 30029, France

Location

Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496

Colmar, Grand Est, 68024, France

Location

CHU Toulouse - Hopital Rangueil /ID# 251879

Toulouse, Haute-Garonne, 31400, France

Location

CHU Montpellier - Hopital Saint Eloi /ID# 252041

Montpellier, Herault, 34295, France

Location

CHU Grenoble - Hopital Michallon /ID# 251937

La Tronche, Isere, 38700, France

Location

Clinique Santé Atlantique /ID# 252581

Saint-Herblain, Loire-Atlantique, 44819, France

Location

CHU Reims - Hôpital Robert Debre /ID# 252017

Reims, Marne, 51092, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 251971

Lille, Nord, 59037, France

Location

Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 251972

Créteil, Paris, 94010, France

Location

AP-HP - Hopital Bicetre /ID# 252329

Le Kremlin-Bicêtre, Paris, 94270, France

Location

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 252265

St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

Centre Hospitalier D'Avignon /ID# 252657

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France

Location

Centre Hospitalier de la Cote Basque /ID# 252358

Bayonne, Pyrenees-Atlantiques, 64100, France

Location

HCL - Hopital Lyon Sud /ID# 252093

Pierre-Bénite, Rhone, 69495, France

Location

CHU Amiens-Picardie Site Sud /ID# 252103

Amiens, Somme, 80054, France

Location

Clinique de l'Europe /ID# 251851

Amiens, Somme, 80090, France

Location

Ch Bethune - Beuvry /Id# 252233

Béthune, 62408, France

Location

Pole Sante Saint-Jean /ID# 252235

Cagnes-sur-Mer, 06800, France

Location

CH Annecy Genevois - Site Annecy /ID# 253010

Epagny Metz Tessy, 74370, France

Location

GHI Le Raincy - Montfermeil /ID# 252733

Montfermeil, 93370, France

Location

Clinique Jules Verne /ID# 251969

Nantes, 44300, France

Location

Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252125

Orléans, 45067, France

Location

Institut Mutualiste Montsouris /ID# 251849

Paris, 75014, France

Location

CHRU Pontchaillou /ID# 252015

Rennes, 35033, France

Location

Centres des maladies de l'appareil digestif /ID# 252283

Strasbourg, 67000, France

Location

Clinique Pasteur /ID# 251893

Toulouse, 31076, France

Location

Hôpital Schuman /ID# 252995

Vantoux, 57070, France

Location

Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Medizinisches Versorgunszentrum Dachau /ID# 257231

Dachau, Bavaria, 85221, Germany

Location

Praxis Dres. Hurst/Simonis /ID# 255159

Darmstadt, Hesse, 64293, Germany

Location

Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224

Frankfurt am Main, Hesse, 60318, Germany

Location

Markus Krankenhaus /ID# 260648

Frankfurt am Main, Hesse, 60431, Germany

Location

Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076

Kassel, Hesse, 34117, Germany

Location

Magen-Darm-Zentrum-Remscheid /ID# 250339

Remscheid, North Rhine-Westphalia, 42859, Germany

Location

Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158

Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

Location

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824

Saarbrücken, Saarland, 66111, Germany

Location

Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873

Leipzig, Saxony, 04105, Germany

Location

Private Practice - Dr. Thomas Zeisler /ID# 250126

Halle, Saxony-Anhalt, 06108, Germany

Location

Praxis S. Tetzlaff /ID# 248263

Buedelsdorf, Schleswig-Holstein, 24782, Germany

Location

Thurman/Bethge /ID# 248305

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Praxis fuer Gastroenterologie /ID# 250749

Lübeck, Schleswig-Holstein, 23560, Germany

Location

Dr. Bernd Adami /ID# 248123

Alzey, 55232, Germany

Location

Dr. Heil /ID# 248273

Andernach, 56626, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979

Berlin, 10117, Germany

Location

Praxis Dr. Michael Mross /ID# 248272

Berlin, 10318, Germany

Location

Krankenhaus Waldfriede /ID# 248307

Berlin-Zehlendorf, 14163, Germany

Location

Praxis Dr. Lukas Buendgens & Dr. Burkhard Buendgens /ID# 254873

Eschweiler, 52249, Germany

Location

Dres. Bauer/Doerflinger /ID# 252107

Freiburg im Breisgau, 79102, Germany

Location

Dres. Behrens/Fechner/Streudel /ID# 250872

Halle, 06108, Germany

Location

Miamedes Hausarztpraxis Altona /ID# 260064

Hamburg, 22767, Germany

Location

Medizinische Hochschule Hannover /ID# 257454

Hanover, 30625, Germany

Location

GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262

Herne, 44623, Germany

Location

Dres. Breitschwerdt/Glas/Gurtler /ID# 251192

Leipzig, 04107, Germany

Location

Bettenworth & Partner /ID# 248977

Münster, 48149, Germany

Location

Gastro Campus Research GbR /ID# 249867

Münster, 48159, Germany

Location

Gastro.Praxis am Meerbachbogen /ID# 251856

Nienburg, 31582, Germany

Location

Praxis Dres Brendel /ID# 250559

Nuremberg, 90449, Germany

Location

Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581

Remscheid, 42859, Germany

Location

Praxis Dr. Kempelmann /ID# 257748

Tostedt, 21255, Germany

Location

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787

Athens, Attica, 11527, Greece

Location

Alexandra General Hospital /ID# 260786

Athens, Attica, 11528, Greece

Location

General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794

Nikaia, Attica, 18454, Greece

Location

University General Hospital of Heraklion PA.G.N.I /ID# 259869

Heraklion, Crete, 71500, Greece

Location

University General Hospital of Alexandroupoli /ID# 270159

Alexandroupoli, Evros, 68100, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259870

Athens, 10676, Greece

Location

General Hospital of Thessaloniki Hippokrateio /ID# 260785

Thessaloniki, 54642, Greece

Location

Connolly Hospital Blanchardstown /ID# 252190

Abbotstown, Dublin, D15 X40D, Ireland

Location

St Vincent's University Hospital /ID# 251855

Elm Park, Dublin, D04 T6F4, Ireland

Location

University Hospital Galway /ID# 253427

Galway, H91 YR71, Ireland

Location

Shamir Medical Center /ID# 256885

Beer Ya'akov, Central District, 70300, Israel

Location

Rambam Health Care Campus /ID# 249884

Haifa, H_efa, 3109601, Israel

Location

Soroka University Medical Center /ID# 249885

Beersheba, Southern District, 8410101, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 250562

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rabin Medical Center /ID# 249474

Petah Tikva, 4941492, Israel

Location

Ente Ospedaliero Specializzato in Gastroenterologia Saverio de Bellis - IRCCS /ID# 261600

Castellana Grotte, Bari, 70013, Italy

Location

IRCCS Istituto Clinico Humanitas /ID# 260801

Rozzano, Lombardy, 20089, Italy

Location

IRCCS Ospedale San Raffaele /ID# 261058

Milan, Milano, 20132, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 260802

Naples, Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260811

Rome, Roma, 00133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 260946

Rome, Roma, 00168, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 261116

Negrar, Verona, 37024, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260812

Milan, 20122, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261052

Palermo, 90146, Italy

Location

Azienda Ospedaliero Universitaria Pisana /ID# 261126

Pisa, 56126, Italy

Location

Mubarak Hospital /ID# 252026

Hawalli, 46300, Kuwait

Location

Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710

Funchal, Madeira, 9000-177, Portugal

Location

Hospital Garcia de Orta /ID# 264420

Almada, Setúbal District, 2805-267, Portugal

Location

Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517

Faro, 8000-386, Portugal

Location

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524

Lisbon, 1349-019, Portugal

Location

Unidade Local de Saude de Santa Maria, EPE /ID# 258759

Lisbon, 1649-035, Portugal

Location

Unidade Local de Saude de Loures-Odivelas, EPE /ID# 272785

Loures, 2674-514, Portugal

Location

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 260038

Porto, 4200-319, Portugal

Location

Centro Hosp de Tondela-Viseu /ID# 258760

Viseu, 3504-509, Portugal

Location

Hamad Medical Corporation /ID# 253823

Zone 51, Baladīyat ar Rayyān, Qatar

Location

Voronezh Regional Clinical Hospital #1 /ID# 249932

Voronezh, 394066, Russia

Location

Hospital Universitari de Bellvitge /ID# 263932

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitari Parc Tauli /ID# 263931

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263929

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Hospital de Cabueñes /ID# 263930

Gijón, Principality of Asturias, 33394, Spain

Location

Hospital Universitario de Canarias /ID# 264214

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Hospital Universitario Virgen Macarena /ID# 263924

Seville, Sevilla, 41009, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 263926

Seville, Sevilla, 41013, Spain

Location

Hospital Galdakao-Usansolo /ID# 263925

Galdakao, Vizcaya, 48960, Spain

Location

Hospital Universitario Torrecárdenas /ID# 264202

Almería, 04009, Spain

Location

Hospital Juan Ramón Jiménez /ID# 267702

Huelva, 21005, Spain

Location

Hospital Universitario de Salamanca /ID# 264207

Salamanca, 37007, Spain

Location

Burjeel Day Surgery Center /ID# 252030

Abu Dhabi, 113818, United Arab Emirates

Location

Cleveland Clinic Abu Dhabi /ID# 252038

Abu Dhabi, United Arab Emirates

Location

Royal Devon & Exeter Hospital /ID# 252734

Exeter, Devon, EX2 5DW, United Kingdom

Location

Hull University Teaching Hospitals NHS Trust /ID# 253988

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

Location

Hampshire Hospitals NHS Foundation Trust /ID# 261416

Basingstoke, Essex, RG24 9NA, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust /ID# 253993

Bury, Lancashire, BL9 7TD, United Kingdom

Location

Kettering General Hospital NHS Foundation Trust /ID# 255263

Kettering, Northamptonshire, NN16 8UZ, United Kingdom

Location

Nottingham City Hospital /ID# 255270

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Oxford University Hospitals - John Radcliffe Hospital /ID# 265343

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Ulster Hospital - South Eastern Health & Social Care Trust /ID# 255265

Belfast, BT16 1RH, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust /ID# 253989

Liverpool, L7 8XP, United Kingdom

Location

Barts Health NHS Trust /ID# 252735

London, E1 2ES, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust /ID# 255271

Tooting, SW17 0QT, United Kingdom

Location

New Cross Hospital /ID# 266364

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Links

• Related info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

DE (32); RU (1); CA (16); KU (1); CZ (5); IT (10); QA (1); AR (3); GB (12); GR (7); IE (3); AU (5); IL (5); AE (2); PT (8); ES (11); FR (31)