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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05930275




Registration number
NCT05930275
Ethics application status
Date submitted
27/06/2023
Date registered
5/07/2023

Titles & IDs
Public title
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.
Scientific 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)
Secondary ID [1] 0 0
P23-899
Universal Trial Number (UTN)
Trial acronym
UPlift
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Upadacitinib - Participants will receive upadacitinib as prescribed by their physician according to local label.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO)
Timepoint [1] 0 0
Up to Week 12
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
At Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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
19/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital /ID# 258574 - Blacktown
Recruitment hospital [2] 0 0
Macquarie University Hospital /ID# 268722 - Macquarie University
Recruitment hospital [3] 0 0
Mater Misericordiae Limited /ID# 258535 - South Brisbane
Recruitment hospital [4] 0 0
Ibd Sa /Id# 268335 - Kurralta Park
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital /ID# 258536 - Woodville South
Recruitment hospital [6] 0 0
Monash Health - Monash Medical Centre /ID# 258538 - Clayton
Recruitment hospital [7] 0 0
The Alfred Hospital /ID# 258537 - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Plovdiv
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Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Bulgaria
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Sofiya
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Bulgaria
State/province [4] 0 0
Varna
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Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Chongqing
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China
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Guangdong
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China
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Jiangsu
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China
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Shanghai
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China
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Sichuan
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China
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Zhejiang
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Denmark
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Hovedstaden
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Estonia
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Harjumaa
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Estonia
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Tartumaa
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France
State/province [20] 0 0
Alpes-Maritimes
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France
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Auvergne-Rhone-Alpes
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France
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Bouches-du-Rhone
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France
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Gironde
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France
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Haute-Garonne
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France
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Herault
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France
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Ile-de-France
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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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France
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Pays-de-la-Loire
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Pyrenees-Atlantiques
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Rhone
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France
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Somme
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France
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Cagnes Sur Mer
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Cholet
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Dijon
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Dreux
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Montpellier
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France
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Rennes
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France
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Strasbourg cedex
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Herne
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Germany
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Magdeburg
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Germany
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Nuernberg
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Germany
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Tostedt
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Greece
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Attiki
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Greece
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Evros
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Thessaloniki
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Hungary
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Hajdu-Bihar
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Hungary
State/province [60] 0 0
Vas
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Hungary
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Budapest
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Hungary
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Szeged
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Ireland
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Dublin
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Italy
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Lombardia
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Italy
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Milano
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Italy
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Monza E Brianza
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Italy
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Roma
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Italy
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Torino
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Japan
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Aichi
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Japan
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Aomori
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Chiba
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Japan
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Fukuoka
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Japan
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Fukushima
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Japan
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Hokkaido
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Hyogo
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Ibaraki
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Iwate
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Kanagawa
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Saga
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Japan
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Saitama
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Japan
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Shiga
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Hiroshima
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Japan
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Mitaka
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Japan
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Sapporo
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Japan
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Tokkyo
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Japan
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Toyama
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Netherlands
State/province [92] 0 0
Gelderland
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Netherlands
State/province [93] 0 0
Noord-Brabant
Country [94] 0 0
Netherlands
State/province [94] 0 0
Noord-Holland
Country [95] 0 0
Romania
State/province [95] 0 0
Bucuresti
Country [96] 0 0
Romania
State/province [96] 0 0
Dolj
Country [97] 0 0
Romania
State/province [97] 0 0
Bucharest
Country [98] 0 0
Romania
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Constanta
Country [99] 0 0
Romania
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Jassi
Country [100] 0 0
Romania
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Timi?oara
Country [101] 0 0
Spain
State/province [101] 0 0
Asturias
Country [102] 0 0
Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Las Palmas
Country [105] 0 0
Spain
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Madrid
Country [106] 0 0
Spain
State/province [106] 0 0
Vizcaya
Country [107] 0 0
Spain
State/province [107] 0 0
Granada
Country [108] 0 0
Spain
State/province [108] 0 0
Murcia
Country [109] 0 0
Spain
State/province [109] 0 0
Pontevedra

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Tanja Plath
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
tanja.plath@abbvie.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05930275