Fact CheckerSign in

NCT05494606Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 28 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
785 (actual)
First submitted
8 Aug 2022
Start date
15 Aug 2022
Primary completion date
Mar 2028
Lead sponsor
AbbVie
NCT number
NCT05494606

What you commit to

  • Study type: Observational
  • Participants enrolled: 785
  • From 15 Aug 2022 to the primary completion date, Mar 2028
  • 153 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants previously exposed to upadacitinib in a clinical trial.

Other

  • Participants with any contraindication to upadacitinib.
  • Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (153)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Burjeel Day Surgery Center /ID# 252030
Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesUnknown status
Cleveland Clinic Abu Dhabi /ID# 252038
Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesUnknown status
Hospital Britanico de Buenos Aires /ID# 249605
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
Gedyt /ID# 249611
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Blacktown Hospital /ID# 248354
Coordinator of this site? Confirm its status
BlacktownAustraliaUnknown status
Austin Health /ID# 249133
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Nepean Hospital /ID# 248351
Coordinator of this site? Confirm its status
KingswoodAustraliaUnknown status
Coral Sea Clinical Research institute /ID# 248352
Coordinator of this site? Confirm its status
North MackayAustraliaUnknown status
The Royal Melbourne Hospital /ID# 248353
Coordinator of this site? Confirm its status
ParkvilleAustraliaUnknown status
Barrie GI Associates /ID# 264978
Coordinator of this site? Confirm its status
BarrieCanadaUnknown status
University of Calgary /ID# 259183
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Gastroenterology and Internal Medicine Research Institution /ID# 251463
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Dr. J Siffledeen Profess Pract /ID# 256903
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Dr. Sundeep Singh, Inc /ID# 251471
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Six08 Gastroenterology /ID# 259452
Coordinator of this site? Confirm its status
LethbridgeCanadaUnknown status
London Health Sciences Center- University Hospital /ID# 258472
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
West GTA Endoscopy /ID# 263221
Coordinator of this site? Confirm its status
MississaugaCanadaUnknown status
The Moncton Hospital /ID# 257337
Coordinator of this site? Confirm its status
MonctonCanadaUnknown status
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Royal Victoria Hospital / McGill University Health Centre /ID# 258470
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Scott Shulman Medicine Professional Corporation /ID# 256826
Coordinator of this site? Confirm its status
North BayCanadaUnknown status
Toronto Immune and Digestive Health Institute Inc /ID# 256827
Coordinator of this site? Confirm its status
North YorkCanadaUnknown status
Diex Recherche Québec /ID# 262796
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Toronto Digestive Disease Associates /ID# 258914
Coordinator of this site? Confirm its status
VaughanCanadaUnknown status
SurGal Clinic /ID# 259809
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Nemocnice Ceske Budejovice a.s. /ID# 259810
Coordinator of this site? Confirm its status
České BudějoviceCzechiaUnknown status
Iscare Klinické Centrum /ID# 259811
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
Fakultni nemocnice Kralovske Vinohrady /ID# 261535
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
Fakultni Thomayerova nemocnice /ID# 261626
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
Dr. Bernd Adami /ID# 248123
Coordinator of this site? Confirm its status
AlzeyGermanyUnknown status
Dr. Heil /ID# 248273
Coordinator of this site? Confirm its status
AndernachGermanyUnknown status
Praxis Dr. Michael Mross /ID# 248272
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Krankenhaus Waldfriede /ID# 248307
Coordinator of this site? Confirm its status
Berlin-ZehlendorfGermanyUnknown status
Praxis S. Tetzlaff /ID# 248263
Coordinator of this site? Confirm its status
BuedelsdorfGermanyUnknown status
Medizinisches Versorgunszentrum Dachau /ID# 257231
Coordinator of this site? Confirm its status
DachauGermanyUnknown status
Praxis Dres. Hurst/Simonis /ID# 255159
Coordinator of this site? Confirm its status
DarmstadtGermanyUnknown status
Praxis Dr. Lukas Buendgens & Dr. Burkhard Buendgens /ID# 254873
Coordinator of this site? Confirm its status
EschweilerGermanyUnknown status
Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyUnknown status
Markus Krankenhaus /ID# 260648
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyUnknown status
Dres. Bauer/Doerflinger /ID# 252107
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyUnknown status
Private Practice - Dr. Thomas Zeisler /ID# 250126
Coordinator of this site? Confirm its status
HalleGermanyUnknown status
Dres. Behrens/Fechner/Streudel /ID# 250872
Coordinator of this site? Confirm its status
HalleGermanyUnknown status
Miamedes Hausarztpraxis Altona /ID# 260064
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Medizinische Hochschule Hannover /ID# 257454
Coordinator of this site? Confirm its status
HanoverGermanyUnknown status
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262
Coordinator of this site? Confirm its status
HerneGermanyUnknown status
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076
Coordinator of this site? Confirm its status
KasselGermanyUnknown status
Thurman/Bethge /ID# 248305
Coordinator of this site? Confirm its status
KielGermanyUnknown status
Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Dres. Breitschwerdt/Glas/Gurtler /ID# 251192
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273
Coordinator of this site? Confirm its status
LübeckGermanyUnknown status
Praxis fuer Gastroenterologie /ID# 250749
Coordinator of this site? Confirm its status
LübeckGermanyUnknown status
Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158
Coordinator of this site? Confirm its status
Ludwigshafen am RheinGermanyUnknown status
Bettenworth & Partner /ID# 248977
Coordinator of this site? Confirm its status
MünsterGermanyUnknown status
Gastro Campus Research GbR /ID# 249867
Coordinator of this site? Confirm its status
MünsterGermanyUnknown status
Gastro.Praxis am Meerbachbogen /ID# 251856
Coordinator of this site? Confirm its status
NienburgGermanyUnknown status
Praxis Dres Brendel /ID# 250559
Coordinator of this site? Confirm its status
NurembergGermanyUnknown status
Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581
Coordinator of this site? Confirm its status
RemscheidGermanyUnknown status
Magen-Darm-Zentrum-Remscheid /ID# 250339
Coordinator of this site? Confirm its status
RemscheidGermanyUnknown status
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824
Coordinator of this site? Confirm its status
SaarbrückenGermanyUnknown status
Praxis Dr. Kempelmann /ID# 257748
Coordinator of this site? Confirm its status
TostedtGermanyUnknown status
Hospital Universitario Torrecárdenas /ID# 264202
Coordinator of this site? Confirm its status
AlmeríaSpainUnknown status
Hospital Galdakao-Usansolo /ID# 263925
Coordinator of this site? Confirm its status
GaldakaoSpainUnknown status
Hospital de Cabueñes /ID# 263930
Coordinator of this site? Confirm its status
GijónSpainUnknown status
Hospital Juan Ramón Jiménez /ID# 267702
Coordinator of this site? Confirm its status
HuelvaSpainUnknown status
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263929
Coordinator of this site? Confirm its status
Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitari de Bellvitge /ID# 263932
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitari Parc Tauli /ID# 263931
Coordinator of this site? Confirm its status
SabadellSpainUnknown status
Hospital Universitario de Salamanca /ID# 264207
Coordinator of this site? Confirm its status
SalamancaSpainUnknown status
Hospital Universitario de Canarias /ID# 264214
Coordinator of this site? Confirm its status
San Cristóbal de La LagunaSpainUnknown status
Hospital Universitario Virgen Macarena /ID# 263924
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Hospital Universitario Virgen del Rocio /ID# 263926
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
CHU Amiens-Picardie Site Sud /ID# 252103
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
Clinique de l'Europe /ID# 251851
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
Centre Hospitalier D'Avignon /ID# 252657
Coordinator of this site? Confirm its status
AvignonFranceUnknown status
Centre Hospitalier de la Cote Basque /ID# 252358
Coordinator of this site? Confirm its status
BayonneFranceUnknown status
CHU de Besancon - Jean Minjoz /ID# 252966
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
Ch Bethune - Beuvry /Id# 252233
Coordinator of this site? Confirm its status
BéthuneFranceUnknown status
Pole Sante Saint-Jean /ID# 252235
Coordinator of this site? Confirm its status
Cagnes-sur-MerFranceUnknown status
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496
Coordinator of this site? Confirm its status
ColmarFranceUnknown status
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 251972
Coordinator of this site? Confirm its status
CréteilFranceUnknown status
CH Annecy Genevois - Site Annecy /ID# 253010
Coordinator of this site? Confirm its status
Epagny Metz TessyFranceUnknown status
CHU Grenoble - Hopital Michallon /ID# 251937
Coordinator of this site? Confirm its status
La TroncheFranceUnknown status
AP-HP - Hopital Bicetre /ID# 252329
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceUnknown status
CHRU Lille - Hopital Claude Huriez /ID# 251971
Coordinator of this site? Confirm its status
LilleFranceUnknown status
APHM - Hopital Nord /ID# 252049
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
GHI Le Raincy - Montfermeil /ID# 252733
Coordinator of this site? Confirm its status
MontfermeilFranceUnknown status
CHU Montpellier - Hopital Saint Eloi /ID# 252041
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Clinique Jules Verne /ID# 251969
Coordinator of this site? Confirm its status
NantesFranceUnknown status
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565
Coordinator of this site? Confirm its status
Neuilly-sur-SeineFranceUnknown status
Chu de Nice-Hopital L'Archet Ii /Id# 251938
Coordinator of this site? Confirm its status
NiceFranceUnknown status
CHU NIMES - Hopital Caremeau /ID# 254790
Coordinator of this site? Confirm its status
NîmesFranceUnknown status
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252125
Coordinator of this site? Confirm its status
OrléansFranceUnknown status
Institut Mutualiste Montsouris /ID# 251849
Coordinator of this site? Confirm its status
ParisFranceUnknown status
HCL - Hopital Lyon Sud /ID# 252093
Coordinator of this site? Confirm its status
Pierre-BéniteFranceUnknown status
CHU Reims - Hôpital Robert Debre /ID# 252017
Coordinator of this site? Confirm its status
ReimsFranceUnknown status
CHRU Pontchaillou /ID# 252015
Coordinator of this site? Confirm its status
RennesFranceUnknown status
Clinique Santé Atlantique /ID# 252581
Coordinator of this site? Confirm its status
Saint-HerblainFranceUnknown status
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 252265
Coordinator of this site? Confirm its status
St-Priest-en-JarezFranceUnknown status
Centres des maladies de l'appareil digestif /ID# 252283
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status
CHU Toulouse - Hopital Rangueil /ID# 251879
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Clinique Pasteur /ID# 251893
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Hôpital Schuman /ID# 252995
Coordinator of this site? Confirm its status
VantouxFranceUnknown status
Hampshire Hospitals NHS Foundation Trust /ID# 261416
Coordinator of this site? Confirm its status
BasingstokeUnited KingdomUnknown status
Ulster Hospital - South Eastern Health & Social Care Trust /ID# 255265
Coordinator of this site? Confirm its status
BelfastUnited KingdomUnknown status
Northern Care Alliance NHS Foundation Trust /ID# 253993
Coordinator of this site? Confirm its status
BuryUnited KingdomUnknown status
Royal Devon & Exeter Hospital /ID# 252734
Coordinator of this site? Confirm its status
ExeterUnited KingdomUnknown status
Hull University Teaching Hospitals NHS Trust /ID# 253988
Coordinator of this site? Confirm its status
HullUnited KingdomUnknown status
Kettering General Hospital NHS Foundation Trust /ID# 255263
Coordinator of this site? Confirm its status
KetteringUnited KingdomUnknown status
Liverpool University Hospitals NHS Foundation Trust /ID# 253989
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomUnknown status
Barts Health NHS Trust /ID# 252735
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Nottingham City Hospital /ID# 255270
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
Oxford University Hospitals - John Radcliffe Hospital /ID# 265343
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
St George's University Hospitals NHS Foundation Trust /ID# 255271
Coordinator of this site? Confirm its status
TootingUnited KingdomUnknown status
New Cross Hospital /ID# 266364
Coordinator of this site? Confirm its status
WolverhamptonUnited KingdomUnknown status
University General Hospital of Alexandroupoli /ID# 270159
Coordinator of this site? Confirm its status
AlexandroupoliGreeceUnknown status
Alexandra General Hospital /ID# 260786
Coordinator of this site? Confirm its status
AthensGreeceUnknown status
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787
Coordinator of this site? Confirm its status
AthensGreeceUnknown status
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259870
Coordinator of this site? Confirm its status
AthensGreeceUnknown status
University General Hospital of Heraklion PA.G.N.I /ID# 259869
Coordinator of this site? Confirm its status
HeraklionGreeceUnknown status
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794
Coordinator of this site? Confirm its status
NikaiaGreeceUnknown status
General Hospital of Thessaloniki Hippokrateio /ID# 260785
Coordinator of this site? Confirm its status
ThessalonikiGreeceUnknown status
Connolly Hospital Blanchardstown /ID# 252190
Coordinator of this site? Confirm its status
AbbotstownIrelandUnknown status
St Vincent's University Hospital /ID# 251855
Coordinator of this site? Confirm its status
Elm ParkIrelandUnknown status
University Hospital Galway /ID# 253427
Coordinator of this site? Confirm its status
GalwayIrelandUnknown status
Soroka University Medical Center /ID# 249885
Coordinator of this site? Confirm its status
BeershebaIsraelUnknown status
Shamir Medical Center /ID# 256885
Coordinator of this site? Confirm its status
Beer Ya'akovIsraelUnknown status
Rambam Health Care Campus /ID# 249884
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Rabin Medical Center /ID# 249474
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 250562
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Ente Ospedaliero Specializzato in Gastroenterologia Saverio de Bellis - IRCCS /ID# 261600
Coordinator of this site? Confirm its status
Castellana GrotteItalyUnknown status
IRCCS Ospedale San Raffaele /ID# 261058
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260812
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Azienda Ospedaliera Universitaria Federico II /ID# 260802
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 261116
Coordinator of this site? Confirm its status
NegrarItalyUnknown status
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261052
Coordinator of this site? Confirm its status
PalermoItalyUnknown status
Azienda Ospedaliero Universitaria Pisana /ID# 261126
Coordinator of this site? Confirm its status
PisaItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260811
Coordinator of this site? Confirm its status
RomeItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 260946
Coordinator of this site? Confirm its status
RomeItalyUnknown status
IRCCS Istituto Clinico Humanitas /ID# 260801
Coordinator of this site? Confirm its status
RozzanoItalyUnknown status
Mubarak Hospital /ID# 252026
Coordinator of this site? Confirm its status
HawalliKuwaitUnknown status
Hospital Garcia de Orta /ID# 264420
Coordinator of this site? Confirm its status
AlmadaPortugalUnknown status
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517
Coordinator of this site? Confirm its status
FaroPortugalUnknown status
Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710
Coordinator of this site? Confirm its status
FunchalPortugalUnknown status
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Unidade Local de Saude de Santa Maria, EPE /ID# 258759
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 272785
Coordinator of this site? Confirm its status
LouresPortugalUnknown status
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 260038
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Centro Hosp de Tondela-Viseu /ID# 258760
Coordinator of this site? Confirm its status
ViseuPortugalUnknown status
Hamad Medical Corporation /ID# 253823
Coordinator of this site? Confirm its status
Zone 51QatarUnknown status
Voronezh Regional Clinical Hospital #1 /ID# 249932
Coordinator of this site? Confirm its status
VoronezhRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.