Assessing the effectiveness of Upadacitinib for Crohn's Disease in real-world settings
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)
This study is testing how well Upadacitinib works and how safe it is for adults with moderate to severe Crohn's Disease in everyday medical settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 177 sites (Blacktown, New South Wales and 176 other locations) |
| Trial ID | NCT05930275 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of Upadacitinib in adults with moderate to severe Crohn's Disease (CD) in real-world clinical practice. Approximately 1200 participants will be enrolled across 230 sites globally, receiving Upadacitinib as prescribed by their physicians. The study will assess the speed of onset and durability of the drug's effectiveness over a follow-up period of up to 3 years, with minimal additional burden on participants. Visits may occur on-site or virtually, aligning with standard care practices.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with moderate to severe Crohn's Disease who are initiating Upadacitinib treatment as part of their routine clinical care.
Not a fit: Patients with contraindications to Upadacitinib or those previously exposed to the drug in clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of Upadacitinib for managing Crohn's Disease.
How similar studies have performed: Other studies have shown positive outcomes with Upadacitinib for Crohn's Disease, indicating a promising approach in this observational context.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Willing and able to participate in the collection of PRO data via a cloud-based application on their personal or provided mobile phone or website app. 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.
Where this trial is running
Blacktown, New South Wales and 176 other locations
- Blacktown Hospital /ID# 258574 — Blacktown, New South Wales, Australia (Completed)
- Macquarie University Hospital /ID# 268722 — Macquarie University, New South Wales, Australia (Recruiting)
- Mater Misericordiae Limited /ID# 258535 — South Brisbane, Queensland, Australia (Recruiting)
- Ibd Sa /Id# 268335 — Kurralta Park, South Australia, Australia (Recruiting)
- The Queen Elizabeth Hospital /ID# 258536 — Woodville South, South Australia, Australia (Recruiting)
- Monash Health - Monash Medical Centre /ID# 258538 — Clayton, Victoria, Australia (Recruiting)
- The Alfred Hospital /ID# 258537 — Melbourne, Victoria, Australia (Recruiting)
- Gastro Med EOOD /ID# 267777 — Pazardzhik, Plovdiv, Bulgaria (Recruiting)
- ET dr Nikolay Tsonev /ID# 267584 — Samokov, Sofia, Bulgaria (Recruiting)
- MC Higia HB /ID# 267575 — Sofiya, Sofia, Bulgaria (Recruiting)
- Umbal Kaspela /ID# 267562 — Plovdiv, Bulgaria (Recruiting)
- Diagnostic consultative center Focus-5 /ID# 267576 — Sofiya, Bulgaria (Recruiting)
- Diagnostic consultative center Focus-5 /ID# 268600 — Sofiya, Bulgaria (Recruiting)
- AIPSMP dr Mirchev EOOD /ID# 267583 — Varna, Bulgaria (Recruiting)
- MC Nadejda Femily EOOD /ID# 267585 — Varna, Bulgaria (Recruiting)
- DCC Mladost M /ID# 267586 — Varna, Bulgaria (Recruiting)
- Foothills Medical Centre /ID# 263475 — Calgary, Alberta, Canada (Recruiting)
- Dr. J Siffledeen Profess Pract /ID# 262713 — Edmonton, Alberta, Canada (Recruiting)
- Fraser Clinical Trials Inc /ID# 262347 — New Westminster, British Columbia, Canada (Completed)
- University of Manitoba & Shared Health /ID# 265853 — Winnipeg, Manitoba, Canada (Recruiting)
- QEII - Health Sciences Centre /ID# 262764 — Halifax, Nova Scotia, Canada (Recruiting)
- Barrie GI Associates /ID# 268436 — Barrie, Ontario, Canada (Recruiting)
- London Health Sciences Center- University Hospital /ID# 262693 — London, Ontario, Canada (Recruiting)
- West GTA Endoscopy /ID# 262946 — Mississauga, Ontario, Canada (Recruiting)
- Scott Shulman Medicine Professional Corporation /ID# 262060 — North Bay, Ontario, Canada (Recruiting)
- Toronto Immune and Digestive Health Institute Inc /ID# 262540 — North York, Ontario, Canada (Recruiting)
- ABP Research Services Corp. /ID# 263111 — Oakville, Ontario, Canada (Recruiting)
- Toronto Digestive Disease Associates /ID# 262050 — Vaughan, Ontario, Canada (Recruiting)
- Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264 — Montreal, Quebec, Canada (Recruiting)
- Royal Victoria Hospital / McGill University Health Centre /ID# 262692 — Montreal, Quebec, Canada (Recruiting)
- Diex Recherche Quebec Inc. /ID# 268256 — Quebec, Canada (Recruiting)
- Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 265873 — Beijing, Beijing, China (Recruiting)
- Chongqing General Hospital /ID# 268384 — Chongqing, Chongqing, China (Recruiting)
- The First Affiliated Hospital, Sun-Yat Sen University /ID# 264189 — Guangzhou, Guangdong, China (Recruiting)
- The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 265673 — Guangzhou, Guangdong, China (Recruiting)
- Nanjing Drum Tower Hospital /ID# 266205 — Nanjing, Jiangsu, China (Recruiting)
- Ruijin Hospital /ID# 266869 — Shanghai, Shanghai, China (Recruiting)
- West China Hospital of Sichuan University /ID# 265674 — Chengdu, Sichuan, China (Recruiting)
- Sichuan Provincial People's Hospital /ID# 270703 — Chengdu, Sichuan, China (Recruiting)
- Jinhua Central Hospital /ID# 265871 — Jinhua, Zhejiang, China (Recruiting)
- SurGal Clinic /ID# 268757 — Brno, Jihomoravsky Kraj, Czechia (Recruiting)
- Herlev Hospital /ID# 262487 — Herlev, Hovedstaden, Denmark (Recruiting)
- Hvidovre Hospital /ID# 262613 — Hvidovre, Hovedstaden, Denmark (Recruiting)
- West Tallinn Central Hospital /ID# 270144 — Tallinn, Harjumaa, Estonia (Recruiting)
- East Tallinn Central Hospital - Magdaleena Unit /ID# 266653 — Tallinn, Harjumaa, Estonia (Recruiting)
- Tartu University Hospital /ID# 270148 — Tartu, Tartumaa, Estonia (Recruiting)
- Chu de Nice-Hopital L'Archet Ii /Id# 261060 — Nice, Alpes-Maritimes, France (Recruiting)
- CHU Clermont-Ferrand /ID# 259294 — Clermont, Auvergne-Rhone-Alpes, France (Recruiting)
- Hopital Edouard Herriot /ID# 266844 — Lyon, Auvergne-Rhone-Alpes, France (Recruiting)
- APHM - Hopital Nord /ID# 259304 — Marseille, Bouches-du-Rhone, France (Recruiting)
+127 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Tanja Plath
- Email: tanja.plath@abbvie.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.