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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
Date last updated
9/08/2024

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
30/09/2028
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
Mater Misericordiae Limited /ID# 258535 - South Brisbane
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital /ID# 258536 - Woodville South
Recruitment hospital [4] 0 0
Monash Medical Centre /ID# 258538 - Clayton
Recruitment hospital [5] 0 0
The Alfred Hospital /ID# 258537 - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
China
State/province [6] 0 0
Guangdong
Country [7] 0 0
China
State/province [7] 0 0
Sichuan
Country [8] 0 0
France
State/province [8] 0 0
Alpes-Maritimes
Country [9] 0 0
France
State/province [9] 0 0
Auvergne-Rhone-Alpes
Country [10] 0 0
France
State/province [10] 0 0
Bouches-du-Rhone
Country [11] 0 0
France
State/province [11] 0 0
Gironde
Country [12] 0 0
France
State/province [12] 0 0
Haute-Corse
Country [13] 0 0
France
State/province [13] 0 0
Haute-Garonne
Country [14] 0 0
France
State/province [14] 0 0
Herault
Country [15] 0 0
France
State/province [15] 0 0
Ile-de-France
Country [16] 0 0
France
State/province [16] 0 0
Marne
Country [17] 0 0
France
State/province [17] 0 0
Nord
Country [18] 0 0
France
State/province [18] 0 0
Pays-de-la-Loire
Country [19] 0 0
France
State/province [19] 0 0
Pyrenees-Atlantiques
Country [20] 0 0
France
State/province [20] 0 0
Rhone
Country [21] 0 0
France
State/province [21] 0 0
Somme
Country [22] 0 0
France
State/province [22] 0 0
Cagnes Sur Mer
Country [23] 0 0
France
State/province [23] 0 0
Cholet
Country [24] 0 0
France
State/province [24] 0 0
Dijon
Country [25] 0 0
France
State/province [25] 0 0
Dreux
Country [26] 0 0
France
State/province [26] 0 0
Le Kremlin Bicetre
Country [27] 0 0
France
State/province [27] 0 0
Lyon
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Rennes
Country [31] 0 0
France
State/province [31] 0 0
Strasbourg cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Nordrhein-Westfalen
Country [33] 0 0
Germany
State/province [33] 0 0
Saarland
Country [34] 0 0
Germany
State/province [34] 0 0
Schleswig-Holstein
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
Herne
Country [39] 0 0
Germany
State/province [39] 0 0
Magdeburg
Country [40] 0 0
Germany
State/province [40] 0 0
Tostedt
Country [41] 0 0
Greece
State/province [41] 0 0
Attiki
Country [42] 0 0
Greece
State/province [42] 0 0
Athens
Country [43] 0 0
Hungary
State/province [43] 0 0
Hajdu-Bihar
Country [44] 0 0
Hungary
State/province [44] 0 0
Vas
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Hungary
State/province [46] 0 0
Szeged
Country [47] 0 0
Japan
State/province [47] 0 0
Fukui
Country [48] 0 0
Japan
State/province [48] 0 0
Fukuoka
Country [49] 0 0
Japan
State/province [49] 0 0
Fukushima
Country [50] 0 0
Japan
State/province [50] 0 0
Hokkaido
Country [51] 0 0
Japan
State/province [51] 0 0
Ibaraki
Country [52] 0 0
Japan
State/province [52] 0 0
Iwate
Country [53] 0 0
Japan
State/province [53] 0 0
Kanagawa
Country [54] 0 0
Japan
State/province [54] 0 0
Saga
Country [55] 0 0
Japan
State/province [55] 0 0
Shiga
Country [56] 0 0
Japan
State/province [56] 0 0
Tochigi
Country [57] 0 0
Japan
State/province [57] 0 0
Chiba
Country [58] 0 0
Japan
State/province [58] 0 0
Mitaka
Country [59] 0 0
Japan
State/province [59] 0 0
Nishinomiya
Country [60] 0 0
Japan
State/province [60] 0 0
Osaka
Country [61] 0 0
Japan
State/province [61] 0 0
Sapporo
Country [62] 0 0
Japan
State/province [62] 0 0
Tokkyo
Country [63] 0 0
Japan
State/province [63] 0 0
Toyama
Country [64] 0 0
Netherlands
State/province [64] 0 0
Zuid-Holland
Country [65] 0 0
Romania
State/province [65] 0 0
Bucuresti
Country [66] 0 0
Romania
State/province [66] 0 0
Olt
Country [67] 0 0
Romania
State/province [67] 0 0
Bucharest
Country [68] 0 0
Romania
State/province [68] 0 0
Jassi
Country [69] 0 0
Romania
State/province [69] 0 0
Timi?oara
Country [70] 0 0
Spain
State/province [70] 0 0
Asturias
Country [71] 0 0
Spain
State/province [71] 0 0
Cordoba
Country [72] 0 0
Spain
State/province [72] 0 0
Las Palmas
Country [73] 0 0
Spain
State/province [73] 0 0
Vizcaya
Country [74] 0 0
Spain
State/province [74] 0 0
Granada

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05930275
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05930275