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.

N/AActive Not RecruitingNCT05930275

AbbVie1,200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. 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.

Locations (180)

Blacktown Hospital /ID# 258574

Blacktown, New South Wales, Australia

Macquarie University Hospital /ID# 268722

Macquarie University, New South Wales, Australia

Mater Misericordiae Limited /ID# 258535

South Brisbane, Queensland, Australia

Ibd Sa /Id# 268335

Kurralta Park, South Australia, Australia

The Queen Elizabeth Hospital /ID# 258536

Woodville South, South Australia, Australia

Outcomes

Primary Outcomes

Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO)

Daily CR-PRO is a composite endpoint defined as the first day with at least 30% decrease in daily very soft or liquid stool frequency (SF) and/or \>= 30% decrease in daily abdominal pain (AP) score and both not worse than baseline and a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO is defined as \>= 30% decrease in average daily very soft or liquid SF and/or \>= 30% decrease in average daily AP score and both not worse than baseline.

Time frame: Up to Week 12

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

Clinical Remission is defined as HBI \<= 4. Clinical Response is defined as HBI reduction \>= 3 points from baseline. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores \< 5 indicate clinical remission, 5 - 7 indicate mild disease activity, 8 - 16 indicate moderate disease activity, and 16 indicate severe disease activity.

Time frame: At Week 52