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

AbbVie

Status: Active, not recruiting

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05841537

P22-920

Details and patient eligibility

About

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.

Enrollment: 1,019 patients

Sex: All

Ages: 15+ years old

Volunteers: No 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.

Trial design

1,019 participants in 1 patient group

Risankizumab

Description:

Participants will receive risankizumab as prescribed by their physician according to local label.