Clinical trial NCT05494606: 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
Official title: Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Upadacitinib
PROFUNDUS
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 785
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderately to severely active Ulcerative colitis (UC)

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score
timeFrame: Up to approximately week 156
measure: 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)
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Gedyt /ID# 249611
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Britanico de Buenos Aires /ID# 249605
state: Ciudad Autonoma De Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
city: Blacktown
country: Australia
facility: Blacktown Hospital /ID# 248354
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital /ID# 248351
state: New South Wales
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research institute /ID# 248352
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health /ID# 249133
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 248353
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary /ID# 259183
state: Alberta
city: Edmonton
country: Canada
facility: Gastroenterology and Internal Medicine Research Institution /ID# 251463
state: Alberta
city: Edmonton
country: Canada
facility: Dr. J Siffledeen Profess Pract /ID# 256903
state: Alberta
city: Lethbridge
country: Canada
facility: Six08 Gastroenterology /ID# 259452
state: Alberta
city: Kelowna
country: Canada
facility: Dr. Sundeep Singh, Inc /ID# 251471
state: British Columbia
city: Moncton
country: Canada
facility: The Moncton Hospital /ID# 257337
state: New Brunswick
city: Barrie
country: Canada
facility: Barrie GI Associates /ID# 264978
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center- University Hospital /ID# 258472
state: Ontario
city: Mississauga
country: Canada
facility: West GTA Endoscopy /ID# 263221
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medicine Professional Corporation /ID# 256826
state: Ontario
city: North York
country: Canada
facility: Toronto Immune and Digestive Health Institute Inc /ID# 256827
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates /ID# 258914
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 258470
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche Québec /ID# 262796
state: Quebec
city: Brno
country: Czechia
facility: SurGal Clinic /ID# 259809
state: Jihomoravsky Kraj
city: Prague
country: Czechia
facility: Iscare Klinické Centrum /ID# 259811
state: Praha 9
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s. /ID# 259810
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady /ID# 261535
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 261626
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 251938
state: Alpes-Maritimes
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 252049
state: Bouches-du-Rhone
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 252966
state: Doubs
city: Nimes CEDEX 9
country: France
facility: CHU NIMES - Hopital Caremeau /ID# 254790
state: Gard
city: Colmar CEDEX
country: France
facility: Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496
state: Grand-Est
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil /ID# 251879
state: Haute-Garonne
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 252041
state: Herault
city: Neuilly Sur Seine
country: France
facility: Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565
state: Ile-de-France
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 251937
state: Isere
city: St Herblain CEDEX
country: France
facility: Clinique Santé Atlantique /ID# 252581
state: Loire-Atlantique
city: St-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 252265
state: Loire
city: Reims CEDEX
country: France
facility: CHU Reims - Hôpital Robert Debre /ID# 252017
state: Marne
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 251971
state: Nord
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 251972
state: Paris
city: Le Kremlin Bicetre
country: France
facility: AP-HP - Hopital Bicetre /ID# 252329
state: Paris
city: Avignon
country: France
facility: Centre Hospitalier D'Avignon /ID# 252657
state: Provence-Alpes-Cote-d Azur
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque /ID# 252358
state: Pyrenees-Atlantiques
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 252093
state: Rhone
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 252103
state: Somme
city: Amiens
country: France
facility: Clinique de l'Europe /ID# 251851
state: Somme
city: Bethune CEDEX
country: France
facility: Ch Bethune - Beuvry /Id# 252233
city: Cagnes Sur Mer
country: France
facility: Pole Sante Saint-Jean /ID# 252235
city: Epagny Metz Tessy
country: France
facility: CH Annecy Genevois - Site Annecy /ID# 253010
city: Montfermeil
country: France
facility: GHI Le Raincy - Montfermeil /ID# 252733
city: Nantes
country: France
facility: Clinique Jules Verne /ID# 251969
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252125
city: Paris
country: France
facility: Institut Mutualiste Montsouris /ID# 251849
city: Rennes
country: France
facility: CHRU Pontchaillou /ID# 252015
city: Strasbourg
country: France
facility: Centres des maladies de l'appareil digestif /ID# 252283
city: Toulouse CEDEX 3
country: France
facility: Clinique Pasteur /ID# 251893
city: Vantoux
country: France
facility: Hôpital Schuman /ID# 252995
city: Dachau
country: Germany
facility: Medizinisches Versorgunszentrum Dachau /ID# 257231
state: Bayern
city: Darmstadt
country: Germany
facility: Praxis Dres. Hurst/Simonis /ID# 255159
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Markus Krankenhaus /ID# 260648
state: Hessen
city: Frankfurt
country: Germany
facility: Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224
state: Hessen
city: Kassel
country: Germany
facility: Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076
state: Hessen
city: Remscheid
country: Germany
facility: Magen-Darm-Zentrum-Remscheid /ID# 250339
state: Nordrhein-Westfalen
city: Ludwigshafen am Rhein
country: Germany
facility: Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158
state: Rheinland-Pfalz
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824
state: Saarland
city: Halle
country: Germany
facility: Private Practice - Dr. Thomas Zeisler /ID# 250126
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873
state: Sachsen
city: Büdelsdorf
country: Germany
facility: Praxis S. Tetzlaff /ID# 248263
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Thurman/Bethge /ID# 248305
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 250749
state: Schleswig-Holstein
city: Alzey
country: Germany
facility: Dr. Bernd Adami /ID# 248123
city: Andernach
country: Germany
facility: Dr. Heil /ID# 248273
city: Berlin-Zehlendorf
country: Germany
facility: Krankenhaus Waldfriede /ID# 248307
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979
city: Berlin
country: Germany
facility: Praxis Dr. Michael Mross /ID# 248272
city: Eschweiler
country: Germany
facility: Praxis Dr. Lukas Buendgens & Dr. Burkhard Buendgens /ID# 254873
city: Freiburg im Breisgau
country: Germany
facility: Dres. Bauer/Doerflinger /ID# 252107
city: Halle (Saale)
country: Germany
facility: Dres. Behrens/Fechner/Streudel /ID# 250872
city: Hamburg
country: Germany
facility: Miamedes Hausarztpraxis Altona /ID# 260064
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 257454
city: Herne
country: Germany
facility: GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262
city: Leipzig
country: Germany
facility: Dres. Breitschwerdt/Glas/Gurtler /ID# 251192
city: Muenster
country: Germany
facility: Gastro Campus Research GbR /ID# 249867
city: Münster
country: Germany
facility: Bettenworth & Partner /ID# 248977
city: Nienburg (Weser)
country: Germany
facility: Gastro.Praxis am Meerbachbogen /ID# 251856
city: Nuernberg
country: Germany
facility: Praxis Dres Brendel /ID# 250559
city: Remscheid
country: Germany
facility: Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581
city: Tostedt
country: Germany
facility: Praxis Dr. Kempelmann /ID# 257748
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787
state: Attiki
city: Athens
country: Greece
facility: Alexandra General Hospital /ID# 260786
state: Attiki
city: Nikaia
country: Greece
facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794
state: Attiki
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupoli /ID# 270159
state: Evros
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 259869
state: Kriti
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259870
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 260785
city: Abbotstown
country: Ireland
facility: Connolly Hospital Blanchardstown /ID# 252190
state: Dublin
city: Elm Park
country: Ireland
facility: St Vincent's University Hospital /ID# 251855
state: Dublin
city: Galway
country: Ireland
facility: University Hospital Galway /ID# 253427
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 249884
state: H_efa
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 249885
state: HaDarom
city: Beer Ya'akov
country: Israel
facility: Shamir Medical Center /ID# 256885
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 250562
state: Tel-Aviv
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 249474
city: Castellana Grotte
country: Italy
facility: Ente Ospedaliero Specializzato in Gastroenterologia Saverio de Bellis - IRCCS /ID# 261600
state: Bari
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 260801
state: Lombardia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 261058
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 260802
state: Napoli
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260811
state: Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 260946
state: Roma
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 261116
state: Verona
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260812
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261052
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 261126
city: Hawalli
country: Kuwait
facility: Mubarak Hospital /ID# 252026
city: Funchal
country: Portugal
facility: Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710
state: Regiao Autonoma Da Madeira
city: Almada
country: Portugal
facility: Hospital Garcia de Orta /ID# 264420
state: Setubal
city: Faro
country: Portugal
facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 258759
city: Loures
country: Portugal
facility: Unidade Local de Saude de Loures-Odivelas, EPE /ID# 272785
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 260038
city: Viseu
country: Portugal
facility: Centro Hosp de Tondela-Viseu /ID# 258760
city: Zone 51
country: Qatar
facility: Hamad Medical Corporation /ID# 253823
state: Ar Rayyan
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1 /ID# 249932
city: Gijón
country: Spain
facility: Hospital de Cabueñes /ID# 263930
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge /ID# 263932
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli /ID# 263931
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263929
state: Las Palmas
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias /ID# 264214
state: Santa Cruz De Tenerife
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 263924
state: Sevilla
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 263926
state: Sevilla
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo /ID# 263925
state: Vizcaya
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas /ID# 264202
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez /ID# 267702
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 264207
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Day Surgery Center /ID# 252030
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi /ID# 252038
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital /ID# 252734
state: Devon
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust /ID# 253988
state: East Riding Of Yorkshire
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust /ID# 261416
state: Essex
city: Bury
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust /ID# 253993
state: Lancashire
city: Kettering
country: United Kingdom
facility: Kettering General Hospital NHS Foundation Trust /ID# 255263
state: Northamptonshire
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital /ID# 255270
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals - John Radcliffe Hospital /ID# 265343
state: Oxfordshire
city: Belfast
country: United Kingdom
facility: Ulster Hospital - South Eastern Health & Social Care Trust /ID# 255265
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust /ID# 253989
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 252735
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust /ID# 255271
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital /ID# 266364
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: