PROFUNDUS: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05494606

Collaborator

(none)

1,000

Enrollment

Locations

61.5

Anticipated Duration (Months)

71.4

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)

Actual Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Sep 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Participants receiving upadacitinib Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

Outcome Measures

Primary Outcome Measures

Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score [Up to approximately week 156]
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
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) [Week 52]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Britanico de Buenos Aires /ID# 249605	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires	Argentina	1280
2	Blacktown Hospital /ID# 248354	Blacktown	New South Wales	Australia	2148
3	Nepean Hospital /ID# 248351	Kingswood	New South Wales	Australia	2747
4	Coral Sea Clinical Research institute /ID# 248352	North Mackay	Queensland	Australia	4740
5	Austin Health /ID# 249133	Heidelberg	Victoria	Australia	3084
6	The Royal Melbourne Hospital /ID# 248353	Parkville	Victoria	Australia	3050
7	Dr. Heil /ID# 248273	Andernach		Germany	56626
8	Krankenhaus Waldfriede /ID# 248307	Berlin-Zehlendorf		Germany	14163
9	Praxis Dr. Michael Mross /ID# 248272	Berlin		Germany	10318
10	Gastro Campus Research GbR /ID# 249867	Muenster		Germany	48159
11	Bettenworth & Partner /ID# 248977	Münster		Germany	48149
12	Krai Clinical Hospital /ID# 249238	Krasnoyarsk		Russian Federation	660022
13	National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 249239	Moscow		Russian Federation	123423
14	City Clinical Hospital No. 31 /ID# 249159	St. Petersburg		Russian Federation	197110