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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum St. Poelten /ID# 258828, Sankt Pölten, Lower Austria, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3

Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: APPRISE

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: May 3, 2023
Registry last updated: May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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