Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

Crohn's Disease Clinical Trial

— UPlift  

Official title:

A Multi-country, Prospective, Post-marketing Study of UPadacitinib Evaluating Speed of Onset and Durability of Effectiveness for Patients With Moderate to Severe Crohn's Disease for 3 Years in Real-world Clinical Practice (UPlift)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930275
• Other study ID #: P23-899
• Status: Recruiting
• Start date: February 19, 2024
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: Tanja Plath
• Email: tanja.plath[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. 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. Study visits may be conducted on-site or virtually as per standard of care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of moderate-to-severe crohn's disease (CD).
• 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.
• Able to understand and communicate with the investigator and comply with the requirements of the study.
• Willing to continue with study documentation after cessation of upadacitinib.

Exclusion Criteria:

• Any contraindication to upadacitinib.
• Previously exposure to upadacitinib in a clinical trial.
• Currently participating in interventional research (not including non-interventional study, post-marketing observational study (PMOS) , or registry participation).
• Initiation of upadacitinib prior to enrollment.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
Australia	Blacktown Hospital /ID# 258574	Blacktown	New South Wales
Australia	Monash Medical Centre /ID# 258538	Clayton	Victoria
Australia	Alfred Health /ID# 258537	Melbourne	Victoria
Australia	The Queen Elizabeth Hospital /ID# 258536	Woodville South	South Australia
Canada	West GTA Endoscopy /ID# 262946	Mississauga	Ontario
Canada	Toronto Immune and Digestive Health Institute Inc /ID# 262540	North York	Ontario
France	Centre Hospitalier de la Cote Basque /ID# 259297	Bayonne	Pyrenees-Atlantiques
France	Ch Chalons En Champagne /Id# 259344	Chalons en Champagne	Marne
France	Centre Hospitalier de CHOLET /ID# 259288	Cholet
France	CHU Clermont-Ferrand /ID# 259294	Clermont	Auvergne-Rhone-Alpes
France	Hopital Beaujon /ID# 259287	Clichy	Ile-de-France
France	CH DREUX - Hopital Victor Jousselin /ID# 258635	Dreux
France	AP-HP - Hôpital Bicêtre /ID# 259118	Le Kremlin Bicetre
France	CHRU Lille - Hopital Claude Huriez /ID# 259302	Lille	Nord
France	APHM - Hopital Nord /ID# 259304	Marseille	Bouches-du-Rhone
France	Clinique Beau Soleil /ID# 259289	Montpellier	Herault
France	Chu de Nice-Hopital Larchet Ii /Id# 261060	Nice	Alpes-Maritimes
France	AP-HP - Hopital Saint-Antoine /ID# 259116	Paris
France	CHRU Pontchaillou /ID# 259347	Rennes
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 259303	St-Priest-en-Jarez
France	CHU de Strasbourg /ID# 259343	Strasbourg cedex
France	CHU Toulouse - Hopital Rangueil /ID# 258636	Toulouse	Haute-Garonne
France	GH Mutualiste Les Portes Du Sud /ID# 259299	Venissieux	Rhone
Germany	Charité Universitätsmedizin Berlin - Campus Mitte /ID# 264097	Berlin
Germany	Gastro Studien GbR /ID# 264617	Berlin
Germany	Praxis S. Tetzlaff /ID# 264613	Büdelsdorf	Schleswig-Holstein
Germany	Fachinternistische Schwerpunktpraxis Dr. Matthias Eichler, Dr. Matthias Kahl /ID# 256105	Hamburg
Germany	SKH Studien GmbH /ID# 256100	Hamburg
Germany	Dres. Schmidt/Büning/Bär, Praxis für Gastroenterologie /ID# 256106	Lübeck	Schleswig-Holstein
Germany	Klinikum Lueneburg /ID# 256107	Lueneburg
Germany	Gastropraxis Magdeburg /ID# 266789	Magdeburg
Germany	Praxis Dr. Kempelmann /ID# 256110	Tostedt
Greece	General State Hospital of Nikaia /ID# 264351	Athens
Hungary	Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156	Budapest
Hungary	Szegedi Tudományegyetem /ID# 258514	Szeged
Japan	Toyama Prefectural Central Hospital /ID# 266088	Toyama

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Australia,  Canada,  France,  Germany,  Greece,  Hungary,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO)	Daily CR-PRO is a composite endpoint defined as the first day with at least 30% decrease in daily very soft or liquid stool frequency (SF) and/or >= 30% decrease in daily abdominal pain (AP) score and both not worse than baseline and a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO is defined as >= 30% decrease in average daily very soft or liquid SF and/or >= 30% decrease in average daily AP score and both not worse than baseline.	Up to Week 12
Primary	Percentage of Participants Achieving Clinical Remission per Harvey Bradshaw Index (HBI) Among those with Clinical Response-Harvey Bradshaw Index (CR-HBI) at End of Induction Therapy	Clinical Remission is defined as HBI <= 4. Clinical Response is defined as HBI reduction >= 3 points from baseline. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores < 5 indicate clinical remission, 5 - 7 indicate mild disease activity, 8 - 16 indicate moderate disease activity, and 16 indicate severe disease activity.	At Week 52

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