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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05494606
Registration number
NCT05494606
Ethics application status
Date submitted
8/08/2022
Date registered
10/08/2022
Date last updated
10/06/2024
Titles & IDs
Public title
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
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Scientific title
Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
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Secondary ID [1]
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P22-921
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Universal Trial Number (UTN)
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Trial acronym
PROFUNDUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants receiving upadacitinib - Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score
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Assessment method [1]
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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
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Timepoint [1]
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Up to approximately week 156
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Primary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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Week 52
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Eligibility
Key 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).
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Minimum age
18
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2028
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Blacktown Hospital /ID# 248354 - Blacktown
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Recruitment hospital [2]
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Nepean Hospital /ID# 248351 - Kingswood
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Recruitment hospital [3]
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Coral Sea Clinical Research institute /ID# 248352 - North Mackay
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Recruitment hospital [4]
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Austin Health /ID# 249133 - Heidelberg
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Recruitment hospital [5]
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The Royal Melbourne Hospital /ID# 248353 - Parkville
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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4740 - North Mackay
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3050 - Parkville
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Argentina
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Ciudad Autonoma De Buenos Aires
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05494606
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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Address
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AbbVie
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Phone
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844-663-3742
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05494606
Download to PDF