AzTrials
AzTrials

Ulcerative ColitisPROFUNDUSNCT05494606

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

An observational study of Ulcerative Colitis, run by AbbVie at 153 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
How many people
785 participants
Where
153 sitesin 17 countries
Study dates
15 Aug 2022to Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

153 sites in 17 countries.

153 sites in 17 countries

Germany32 sites

  • Dr. Bernd Adami /ID# 248123

    Alzey, 55232

  • Dr. Heil /ID# 248273

    Andernach, 56626

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979

    Berlin, 10117

  • Praxis Dr. Michael Mross /ID# 248272

    Berlin, 10318

  • Krankenhaus Waldfriede /ID# 248307

    Berlin-Zehlendorf, 14163

  • Praxis S. Tetzlaff /ID# 248263

    Buedelsdorf, Schleswig-Holstein, 24782

  • Medizinisches Versorgunszentrum Dachau /ID# 257231

    Dachau, Bavaria, 85221

  • Praxis Dres. Hurst/Simonis /ID# 255159

    Darmstadt, Hesse, 64293

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

    Eschweiler, 52249

  • Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224

    Frankfurt am Main, Hesse, 60318

  • Markus Krankenhaus /ID# 260648

    Frankfurt am Main, Hesse, 60431

  • Dres. Bauer/Doerflinger /ID# 252107

    Freiburg im Breisgau, 79102

  • Private Practice - Dr. Thomas Zeisler /ID# 250126

    Halle, Saxony-Anhalt, 06108

  • Dres. Behrens/Fechner/Streudel /ID# 250872

    Halle, 06108

  • Miamedes Hausarztpraxis Altona /ID# 260064

    Hamburg, 22767

  • Medizinische Hochschule Hannover /ID# 257454

    Hanover, 30625

  • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262

    Herne, 44623

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

    Kassel, Hesse, 34117

  • Thurman/Bethge /ID# 248305

    Kiel, Schleswig-Holstein, 24105

  • Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873

    Leipzig, Saxony, 04105

  • Dres. Breitschwerdt/Glas/Gurtler /ID# 251192

    Leipzig, 04107

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273

    Lübeck, Schleswig-Holstein, 23538

  • Praxis fuer Gastroenterologie /ID# 250749

    Lübeck, Schleswig-Holstein, 23560

  • Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • Bettenworth & Partner /ID# 248977

    Münster, 48149

  • Gastro Campus Research GbR /ID# 249867

    Münster, 48159

  • Gastro.Praxis am Meerbachbogen /ID# 251856

    Nienburg, 31582

  • Praxis Dres Brendel /ID# 250559

    Nuremberg, 90449

  • Magen-Darm-Zentrum-Remscheid /ID# 250339

    Remscheid, North Rhine-Westphalia, 42859

  • Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581

    Remscheid, 42859

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824

    Saarbrücken, Saarland, 66111

  • Praxis Dr. Kempelmann /ID# 257748

    Tostedt, 21255

Other trials in Germany

France31 sites

  • CHU Amiens-Picardie Site Sud /ID# 252103

    Amiens, Somme, 80054

  • Clinique de l'Europe /ID# 251851

    Amiens, Somme, 80090

  • Centre Hospitalier D'Avignon /ID# 252657

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

  • Centre Hospitalier de la Cote Basque /ID# 252358

    Bayonne, Pyrenees-Atlantiques, 64100

  • CHU de Besancon - Jean Minjoz /ID# 252966

    Besançon, Doubs, 25030

  • Ch Bethune - Beuvry /Id# 252233

    Béthune, 62408

  • Pole Sante Saint-Jean /ID# 252235

    Cagnes-sur-Mer, 06800

  • Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496

    Colmar, Grand Est, 68024

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

    Créteil, Paris, 94010

  • CH Annecy Genevois - Site Annecy /ID# 253010

    Epagny Metz Tessy, 74370

  • CHU Grenoble - Hopital Michallon /ID# 251937

    La Tronche, Isere, 38700

  • AP-HP - Hopital Bicetre /ID# 252329

    Le Kremlin-Bicêtre, Paris, 94270

  • CHRU Lille - Hopital Claude Huriez /ID# 251971

    Lille, Nord, 59037

  • APHM - Hopital Nord /ID# 252049

    Marseille, Bouches-du-Rhone, 13015

  • GHI Le Raincy - Montfermeil /ID# 252733

    Montfermeil, 93370

  • CHU Montpellier - Hopital Saint Eloi /ID# 252041

    Montpellier, Herault, 34295

  • Clinique Jules Verne /ID# 251969

    Nantes, 44300

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565

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

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

    Nice, Alpes-Maritimes, 06202

  • CHU NIMES - Hopital Caremeau /ID# 254790

    Nîmes, Gard, 30029

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

    Orléans, 45067

  • Institut Mutualiste Montsouris /ID# 251849

    Paris, 75014

  • HCL - Hopital Lyon Sud /ID# 252093

    Pierre-Bénite, Rhone, 69495

  • CHU Reims - Hôpital Robert Debre /ID# 252017

    Reims, Marne, 51092

  • CHRU Pontchaillou /ID# 252015

    Rennes, 35033

  • Clinique Santé Atlantique /ID# 252581

    Saint-Herblain, Loire-Atlantique, 44819

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

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

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

    Strasbourg, 67000

  • CHU Toulouse - Hopital Rangueil /ID# 251879

    Toulouse, Haute-Garonne, 31400

  • Clinique Pasteur /ID# 251893

    Toulouse, 31076

  • Hôpital Schuman /ID# 252995

    Vantoux, 57070

Other trials in France

Canada16 sites

  • Barrie GI Associates /ID# 264978

    Barrie, Ontario, L4M 7G1

  • University of Calgary /ID# 259183

    Calgary, Alberta, T2N 4Z6

  • Gastroenterology and Internal Medicine Research Institution /ID# 251463

    Edmonton, Alberta, T5R 1W2

  • Dr. J Siffledeen Profess Pract /ID# 256903

    Edmonton, Alberta, T6L 6K3

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

    Hamilton, Ontario, L8S 4K1

  • Dr. Sundeep Singh, Inc /ID# 251471

    Kelowna, British Columbia, V1Y 6J6

  • Six08 Gastroenterology /ID# 259452

    Lethbridge, Alberta, T1J 4G9

  • London Health Sciences Center- University Hospital /ID# 258472

    London, Ontario, N6A 5W9

  • West GTA Endoscopy /ID# 263221

    Mississauga, Ontario, L5M 2S4

  • The Moncton Hospital /ID# 257337

    Moncton, New Brunswick, E1C 6Z8

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

    Montreal, Quebec, H1T 2M4

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

    Montreal, Quebec, H4A 3J1

  • Scott Shulman Medicine Professional Corporation /ID# 256826

    North Bay, Ontario, P1B 2H3

  • Toronto Immune and Digestive Health Institute Inc /ID# 256827

    North York, Ontario, M6A 3B4

  • Diex Recherche Québec /ID# 262796

    Québec, Quebec, G1V 4T3

  • Toronto Digestive Disease Associates /ID# 258914

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

United Kingdom12 sites

  • Hampshire Hospitals NHS Foundation Trust /ID# 261416

    Basingstoke, Essex, RG24 9NA

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

    Belfast, BT16 1RH

  • Northern Care Alliance NHS Foundation Trust /ID# 253993

    Bury, Lancashire, BL9 7TD

  • Royal Devon & Exeter Hospital /ID# 252734

    Exeter, Devon, EX2 5DW

  • Hull University Teaching Hospitals NHS Trust /ID# 253988

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • Kettering General Hospital NHS Foundation Trust /ID# 255263

    Kettering, Northamptonshire, NN16 8UZ

  • Liverpool University Hospitals NHS Foundation Trust /ID# 253989

    Liverpool, L7 8XP

  • Barts Health NHS Trust /ID# 252735

    London, E1 2ES

  • Nottingham City Hospital /ID# 255270

    Nottingham, Nottinghamshire, NG5 1PB

  • Oxford University Hospitals - John Radcliffe Hospital /ID# 265343

    Oxford, Oxfordshire, OX3 9DU

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

    Tooting, SW17 0QT

  • New Cross Hospital /ID# 266364

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Spain11 sites

  • Hospital Universitario Torrecárdenas /ID# 264202

    Almería, 04009

  • Hospital Galdakao-Usansolo /ID# 263925

    Galdakao, Vizcaya, 48960

  • Hospital de Cabueñes /ID# 263930

    Gijón, Principality of Asturias, 33394

  • Hospital Juan Ramón Jiménez /ID# 267702

    Huelva, 21005

  • Hospital Universitari de Bellvitge /ID# 263932

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263929

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital Universitari Parc Tauli /ID# 263931

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca /ID# 264207

    Salamanca, 37007

  • Hospital Universitario de Canarias /ID# 264214

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

  • Hospital Universitario Virgen Macarena /ID# 263924

    Seville, Sevilla, 41009

  • Hospital Universitario Virgen del Rocio /ID# 263926

    Seville, Sevilla, 41013

Other trials in Spain

Italy10 sites

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

    Castellana Grotte, Bari, 70013

  • IRCCS Ospedale San Raffaele /ID# 261058

    Milan, Milano, 20132

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

    Milan, 20122

  • Azienda Ospedaliera Universitaria Federico II /ID# 260802

    Naples, Napoli, 80131

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 261116

    Negrar, Verona, 37024

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261052

    Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana /ID# 261126

    Pisa, 56126

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260811

    Rome, Roma, 00133

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

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 260801

    Rozzano, Lombardy, 20089

Other trials in Italy

Portugal8 sites

  • Hospital Garcia de Orta /ID# 264420

    Almada, Setúbal District, 2805-267

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

    Faro, 8000-386

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

    Funchal, Madeira, 9000-177

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

    Lisbon, 1349-019

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

    Lisbon, 1649-035

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

    Loures, 2674-514

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

    Porto, 4200-319

  • Centro Hosp de Tondela-Viseu /ID# 258760

    Viseu, 3504-509

Other trials in Portugal

Greece7 sites

  • University General Hospital of Alexandroupoli /ID# 270159

    Alexandroupoli, Evros, 68100

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

    Athens, Attica, 11527

  • Alexandra General Hospital /ID# 260786

    Athens, Attica, 11528

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

    Athens, 10676

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

    Heraklion, Crete, 71500

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

    Nikaia, Attica, 18454

  • General Hospital of Thessaloniki Hippokrateio /ID# 260785

    Thessaloniki, 54642

Other trials in Greece

Australia5 sites

  • Blacktown Hospital /ID# 248354

    Blacktown, New South Wales, 2148

  • Austin Health /ID# 249133

    Heidelberg, Victoria, 3084

  • Nepean Hospital /ID# 248351

    Kingswood, New South Wales, 2747

  • Coral Sea Clinical Research institute /ID# 248352

    North Mackay, Queensland, 4740

  • The Royal Melbourne Hospital /ID# 248353

    Parkville, Victoria, 3050

Other trials in Australia

Czechia5 sites

  • SurGal Clinic /ID# 259809

    Brno, South Moravian, 602 00

  • Nemocnice Ceske Budejovice a.s. /ID# 259810

    České Budějovice, 370 01

  • Iscare Klinické Centrum /ID# 259811

    Prague, Praha 9, 190 00

  • Fakultni nemocnice Kralovske Vinohrady /ID# 261535

    Prague, 100 34

  • Fakultni Thomayerova nemocnice /ID# 261626

    Prague, 140 59

Other trials in Czechia

Israel5 sites

  • Shamir Medical Center /ID# 256885

    Beer Ya'akov, Central District, 70300

  • Soroka University Medical Center /ID# 249885

    Beersheba, Southern District, 8410101

  • Rambam Health Care Campus /ID# 249884

    Haifa, H_efa, 3109601

  • Rabin Medical Center /ID# 249474

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center /ID# 250562

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Argentina3 sites

  • Gedyt /ID# 249611

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

  • Hospital Britanico de Buenos Aires /ID# 249605

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

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

    Córdoba, 5016

Other trials in Argentina

Ireland3 sites

  • Connolly Hospital Blanchardstown /ID# 252190

    Abbotstown, Dublin, D15 X40D

  • St Vincent's University Hospital /ID# 251855

    Elm Park, Dublin, D04 T6F4

  • University Hospital Galway /ID# 253427

    Galway, H91 YR71

Other trials in Ireland

United Arab Emirates2 sites

  • Burjeel Day Surgery Center /ID# 252030

    Abu Dhabi, 113818

  • Cleveland Clinic Abu Dhabi /ID# 252038

    Abu Dhabi

Other trials in United Arab Emirates

Kuwait1 site

  • Mubarak Hospital /ID# 252026

    Hawalli, 46300

Other trials in Kuwait

Qatar1 site

  • Hamad Medical Corporation /ID# 253823

    Zone 51, Baladiyat ar Rayyan

Other trials in Qatar

Russia1 site

  • Voronezh Regional Clinical Hospital #1 /ID# 249932

    Voronezh, 394066

Other trials in Russia

About this study

Official title: Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)

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.

Read more

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.

Keywords
Ulcerative Colitis, Upadacitinib, PROFUNDUS, RINVOQ
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05494606
Study groupRoleWhat they receive
Participants receiving upadacitinibParticipants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to approximately week 156

  2. 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.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2022
  2. Study start15 Aug 2022
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
785 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05494606
Sponsor's protocol ID
P22-921
Acronym
PROFUNDUS
Status last verified
Feb 2025
First submitted
8 Aug 2022
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by AbbVie at 153 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in Germany, France, Canada, United Kingdom, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score (time frame: Up to approximately week 156). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05494606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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