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NCT05930275 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 19, 2024
Est. completion date September 30, 2028

Study information
Verified date June 2024
Source AbbVie
Contact Tanja Plath
Email tanja.plath@abbvie.com
Is FDA regulated No
Health authority
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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Monash Medical Centre /ID# 258538 Clayton Victoria
Australia Macquarie University Hospital /ID# 258574 Macquarie Park New South Wales
Australia The Alfred Hospital /ID# 258537 Melbourne Victoria
Australia The Queen Elizabeth Hospital /ID# 258536 Woodville South South Australia
Canada West GTA Endoscopy /ID# 262946 Mississauga Ontario
Canada Fraser Clinical Trials Inc /ID# 262347 New Westminster British Columbia
Canada Scott Shulman Medicine Professional Corporation /ID# 262060 North Bay Ontario
Canada Toronto Immune and Digestive Health Institute Inc /ID# 262540 North York Ontario
Canada ABP Research Services Corp. /ID# 263111 Oakville Ontario
Canada Toronto Digestive Disease Associates, Inc. /ID# 262050 Vaughan Ontario
China The First Affiliated Hospital, Sun-Yat Sen University /ID# 264189 Guangzhou Guangdong
France CHU Amiens-Picardie Site Sud /ID# 259121 Amiens CEDEX 1 Somme
France Centre Hospitalier de la Cote Basque /ID# 259297 Bayonne Pyrenees-Atlantiques
France Pole Sante Saint-Jean /ID# 259296 Cagnes Sur Mer
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 Nantes, Hotel Dieu -HME /ID# 259293 Nantes Pays-de-la-Loire
France Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 259339 Neuilly Sur Seine Ile-de-France
France Chu de Nice-Hopital Larchet Ii /Id# 261060 Nice Alpes-Maritimes
France AP-HP - Hopital Saint-Antoine /ID# 259116 Paris
France Centre Hospitalier Universitaire de Bordeaux /ID# 259298 Pessac CEDEX Gironde
France CHRU Pontchaillou /ID# 259347 Rennes
France Cabinet du docteur Médina Boualit /ID# 259291 St Amand les Eaux Nord
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 GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 268434 Herne
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 Dres. Kamp & Partner /ID# 267560 Minden Nordrhein-Westfalen
Germany Praxis Dr. Kempelmann /ID# 256110 Tostedt
Greece Evangelismos Hospital /ID# 268132 Athens Attiki
Greece General State Hospital of Nikaia /ID# 264351 Athens
Hungary Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156 Budapest
Hungary Debreceni Egyetem-Klinikai Kozpont /ID# 258518 Debrecen Hajdu-Bihar
Hungary Szegedi Tudományegyetem /ID# 258514 Szeged
Hungary Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 258517 Szombathely Vas
Japan Asahikawa Medical College Hospital /ID# 266062 Asahikawa
Japan Hyogo Medical University Hospital /ID# 266097 Nishinomiya
Japan Saga University Hospital /ID# 267884 Saga
Japan Sapporo Medical University Hospital /ID# 265042 Sapporo Hokkaido
Japan Hokkaido University Hospital /ID# 266063 Sapporo-shi Hokkaido
Japan Toyama Prefectural Central Hospital /ID# 266088 Toyama
Spain Hospital Universitario Reina Sofia /ID# 263461 Córdoba Cordoba
Spain Hospital Universitario Virgen de las Nieves /ID# 264206 Granada

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

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

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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Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
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