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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05494606




Registration number
NCT05494606
Ethics application status
Date submitted
8/08/2022
Date registered
10/08/2022
Date last updated
1/11/2024

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
Scientific title
Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
Secondary ID [1] 0 0
P22-921
Universal Trial Number (UTN)
Trial acronym
PROFUNDUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants receiving upadacitinib - Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score
Timepoint [1] 0 0
Up to approximately week 156
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Week 52

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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital /ID# 248354 - Blacktown
Recruitment hospital [2] 0 0
Nepean Hospital /ID# 248351 - Kingswood
Recruitment hospital [3] 0 0
Coral Sea Clinical Research institute /ID# 248352 - North Mackay
Recruitment hospital [4] 0 0
Austin Health /ID# 249133 - Heidelberg
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital /ID# 248353 - Parkville
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4740 - North Mackay
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad Autonoma De Buenos Aires
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Argentina
State/province [2] 0 0
Cordoba
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Canada
State/province [3] 0 0
Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Jihomoravsky Kraj
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Czechia
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Praha 9
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Czechia
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Ceske Budejovice
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Czechia
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Praha
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France
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Alpes-Maritimes
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Bouches-du-Rhone
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Doubs
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Gard
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Herault
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Ile-de-France
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France
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Isere
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France
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Loire
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Marne
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Nord
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Paris
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Rennes
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Sachsen
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Alzey
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Berlin
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Eschweiler
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Tostedt
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Voronezh
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Vizcaya
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Huelva
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Salamanca
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Abu Dhabi
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United Kingdom
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Devon
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East Riding Of Yorkshire
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Essex
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Lancashire
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Nottinghamshire
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Oxfordshire
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Belfast
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Liverpool
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London
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Tooting
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05494606
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05494606