Crohn's Disease
Conditions
Keywords
Crohn's disease, CD, Upadacitinib
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO) | Up to Week 12 | 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. |
| 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 | At Week 52 | 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. |
Countries
Australia, Bulgaria, Canada, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Netherlands, Romania, Spain
Outcome results
None listed