An Observational Study to Assess Change in Disease Activi... | NCT05494606

Studies
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

NCT05494606

Sponsor

AbbVie

Status

Active, not recruiting

Last Update Posted

Feb 28, 2025Actual

Enrollment

785Actual

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

Not provided

Countries

Argentina
Australia
Canada
Czechia
France
Germany
Greece
Ireland
Israel
Italy
Kuwait
Portugal
Qatar
Russia
Spain
United Arab Emirates
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2022Actual

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Aug 8, 2022

First Submission Date that Met QC Criteria

Aug 8, 2022

First Posted Date

Aug 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2025

Last Update Posted Date

Feb 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

785Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants receiving upadacitinib		Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Adult participants with moderately to severely active Ulcerative colitis (UC)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gedyt /ID# 249611		Ciudad Autonoma de Buenos Aire	Buenos Aires F.D.	1115	Argentina
Hospital Britanico de Buenos Aires /ID# 249605

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases