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

Ulcerative Colitis Clinical Trial

— PROFUNDUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494606
• Other study ID #: P22-921
• Status: Recruiting
• Start date: August 15, 2022
• Est. completion date: March 31, 2028

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Argentina	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
Australia	Blacktown Hospital /ID# 248354	Blacktown	New South Wales
Australia	Austin Health /ID# 249133	Heidelberg	Victoria
Australia	Nepean Hospital /ID# 248351	Kingswood	New South Wales
Australia	Coral Sea Clinical Research institute /ID# 248352	North Mackay	Queensland
Australia	The Royal Melbourne Hospital /ID# 248353	Parkville	Victoria
Canada	Barrie GI Associates /ID# 264978	Barrie	Ontario
Canada	University of Calgary /ID# 259183	Calgary	Alberta
Canada	Dr. J Siffledeen Profess Pract /ID# 256903	Edmonton	Alberta
Canada	Gastroenterology and Internal Medicine Research Institution /ID# 251463	Edmonton	Alberta
Canada	Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819	Hamilton	Ontario
Canada	Dr. Sundeep Singh, Inc /ID# 251471	Kelowna	British Columbia
Canada	Six08 Gastroenterology /ID# 259452	Lethbridge	Alberta
Canada	London Health Sciences Center- University Hospital /ID# 258472	London	Ontario
Canada	West GTA Endoscopy /ID# 263221	Mississauga	Ontario
Canada	The Moncton Hospital /ID# 257337	Moncton	New Brunswick
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	Scott Shulman Medicine Professional Corporation /ID# 256826	North Bay	Ontario
Canada	Toronto Immune and Digestive Health Institute Inc /ID# 256827	North York	Ontario
Canada	Diex Recherche Québec Inc. /ID# 262796	Québec	Quebec
Canada	Toronto Digestive Disease Associates, Inc. /ID# 258914	Vaughan	Ontario
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 259810	Ceske Budejovice
Czechia	Iscare Klinické Centrum /ID# 259811	Prague	Praha 9
Czechia	Fakultni nemocnice Kralovske Vinohrady /ID# 261535	Praha
France	Clinique de l'Europe /ID# 251851	Amiens	Somme
France	CHU Amiens-Picardie Site Sud /ID# 252103	Amiens CEDEX 1	Somme
France	Centre Hospitalier D'Avignon /ID# 252657	Avignon
France	Centre Hospitalier de la Cote Basque /ID# 252358	Bayonne	Pyrenees-Atlantiques
France	CHU de Besancon - Jean Minjoz /ID# 252966	Besancon	Doubs
France	Ch Bethune - Beuvry /Id# 252233	Bethune CEDEX
France	Pole Sante Saint-Jean /ID# 252235	Cagnes Sur Mer
France	Hopitaux Civils de Colmar /ID# 252496	Colmar
France	CH Annecy Genevois - Site Annecy /ID# 253010	Epagny Metz Tessy
France	CHU Grenoble - Hopital Michallon /ID# 251937	La Tronche	Isere
France	CHRU Lille - Hopital Claude Huriez /ID# 251971	Lille	Nord
France	APHM - Hopital Nord /ID# 252049	Marseille	Bouches-du-Rhone
France	GHI Le Raincy - Montfermeil /ID# 252733	Montfermeil
France	CHU Montpellier - Hopital Saint Eloi /ID# 252041	Montpellier Cedex 5	Herault
France	Clinique Jules Verne /ID# 251969	Nantes
France	Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565	Neuilly Sur Seine	Ile-de-France
France	Chu de Nice-Hopital Larchet Ii /Id# 251938	Nice	Alpes-Maritimes
France	CHU NIMES - Hopital Caremeau /ID# 254790	Nimes CEDEX 9	Gard
France	Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252125	Orléans
France	Institut Mutualiste Montsouris /ID# 251849	Paris
France	HCL - Hopital Lyon Sud /ID# 252093	Pierre Benite CEDEX	Rhone
France	CHU Reims - Hôpital Robert Debre /ID# 252017	Reims CEDEX	Marne
France	CHRU Pontchaillou /ID# 252015	Rennes
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
France	Centres des maladies de l'appareil digestif /ID# 252283	Strasbourg
France	CHU Toulouse - Hopital Rangueil /ID# 251879	Toulouse	Haute-Garonne
France	Clinique Pasteur /ID# 251893	Toulouse CEDEX 3
France	Hôpital Schuman /ID# 252995	Vantoux
Germany	Dr. Bernd Adami /ID# 248123	Alzey
Germany	Dr. Heil /ID# 248273	Andernach
Germany	Charité Universitätsmedizin Berlin - Campus Mitte /ID# 248979	Berlin
Germany	Praxis Dr. Michael Mross /ID# 248272	Berlin
Germany	Krankenhaus Waldfriede /ID# 248307	Berlin-Zehlendorf
Germany	Praxis S. Tetzlaff /ID# 248263	Büdelsdorf	Schleswig-Holstein
Germany	Medizinisches Versorgunszentrum Dachau /ID# 257231	Dachau
Germany	Praxis Dres. Hurst/Simonis /ID# 255159	Darmstadt
Germany	Praxis Dr. Lukas Buendgens & Dr. Burkhard Buendgens /ID# 254873	Eschweiler
Germany	Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224	Frankfurt
Germany	Markus Krankenhaus /ID# 260648	Frankfurt am Main	Hessen
Germany	Dres. Bauer/Doerflinger /ID# 252107	Freiburg im Breisgau
Germany	Dr. Zeisler, Halle, DE /ID# 250126	Halle
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	Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076	Kassel
Germany	Thurman/Bethge /ID# 248305	Kiel
Germany	Dres. Breitschwerdt/Glas/Gurtler /ID# 251192	Leipzig
Germany	Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873	Leipzig
Germany	Dres. Schmidt/Büning/Bär, Praxis für Gastroenterologie /ID# 250749	Lübeck	Schleswig-Holstein
Germany	Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273	Lübeck	Schleswig-Holstein
Germany	Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158	Ludwigshafen am Rhein	Rheinland-Pfalz
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	Magen-Darm-Zentrum-Remscheid /ID# 250339	Remscheid	Nordrhein-Westfalen
Germany	Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581	Remscheid
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824	Saarbrücken	Saarland
Germany	Praxis Dr. Kempelmann /ID# 257748	Tostedt
Greece	Alexandra General Hospital /ID# 260786	Athens	Attiki
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259870	Athens
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 259869	Heraklion	Kriti
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794	Nikaia
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 260785	Thessaloniki
Ireland	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
Israel	Soroka University Medical Center /ID# 249885	Be'er Sheva	HaDarom
Israel	Shamir Medical Center /ID# 256885	Beer Ya'akov	HaMerkaz
Israel	Rabin Medical Center /ID# 249474	Haifa
Israel	Rambam Health Care Campus /ID# 249884	Haifa	H_efa
Israel	Tel Aviv Sourasky Medical Center /ID# 250562	Tel Aviv	Tel-Aviv
Italy	Ospedale San Raffaele IRCCS /ID# 261058	Milan	Milano
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 260802	Napoli
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 261052	Palermo
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 260811	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 260801	Rozzano	Milano
Kuwait	Mubarak Hospital /ID# 252026	Hawalli
Portugal	Hospital Garcia de Orta /ID# 264420	Almada	Setubal
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517	Faro
Portugal	Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524	Lisboa
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 258759	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 260038	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 258760	Viseu
Russian Federation	Voronezh Regional Clinical Hospital #1 /ID# 249932	Voronezh
Spain	Hospital Universitario Torrecárdenas /ID# 264202	Almería
Spain	Hospital Universitario de Canarias /ID# 264214	San Cristóbal de La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Virgen del Rocio /ID# 263926	Seville	Sevilla
Spain	Hospital Universitario Virgen Macarena /ID# 263924	Seville	Sevilla
United Arab Emirates	Burjeel Day Surgery Center /ID# 252030	Abu Dhabi
United Arab Emirates	Cleveland Clinic Abu Dhabi /ID# 252038	Abu Dhabi
United Kingdom	Hampshire Hospitals NHS Foundation Trust /ID# 261416	Basingstoke	Essex
United Kingdom	Ulster Hospital - South Eastern Health & Social Care Trust /ID# 255265	Belfast
United Kingdom	Northern Care Alliance NHS Foundation Trust /ID# 253993	Bury	Lancashire
United Kingdom	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	Kettering General Hospital NHS Foundation Trust /ID# 255263	Kettering	Northamptonshire
United Kingdom	Liverpool University Hospitals NHS Foundation Trust /ID# 253989	Liverpool
United Kingdom	Barts Health NHS Trust /ID# 252735	London
United Kingdom	Nottingham City Hospital /ID# 255270	Nottingham	Nottinghamshire
United Kingdom	Oxford University Hospitals - John Radcliffe Hospital /ID# 265343	Oxford
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 255271	Tooting
United Kingdom	New Cross Hospital /ID# 266364	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  Czechia,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Kuwait,  Portugal,  Russian Federation,  Spain,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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