An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05841537

Acronym

APPRISE

Enrollment

1019

Registered

2023-05-03

Start date

2023-06-09

Completion date

2028-07-31

Last updated

2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease, CD, Risankizumab

Brief summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices. * Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care. * Participants prescribed risankizumab 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 and able to provide authorization to use and disclose personal health information. * Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone).

Exclusion criteria

* Females who are pregnant or breast feeding at baseline. * Participants with any contraindication to risankizumab. * Participants previously exposed to risankizumab. * Participants currently participating in an interventional clinical trial.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3	At Month 12	Clinical Remission is defined as HBI \<= 4. Clinical Response is defined as HBI reduction \>= 3 points. 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, 8 - 16 indicate moderate disease, and 16 indicate severe disease.

Countries

Austria, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Arab Emirates

Outcome results