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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 15 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Exclusion Criteria:

  • - Participants with any contraindication to risankizumab.
  • - Participants previously exposed to risankizumab in a clinical trial.
  • - Participants currently participating in an interventional clinical trial.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Canada

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Study Website: View Trial Website
Arms & Interventions


: Risankizumab

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


Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Edmonton, Alberta, Canada




Gastroenterology and Internal Medicine Research Institution /ID# 253319

Edmonton, Alberta, T5R 1W2

Edmonton, Alberta, Canada




South Edmonton Gastroenterology Research Clinic /ID# 253160

Edmonton, Alberta, T6K 4B2

Dr. Sundeep Singh, Inc /ID# 254250, Kelowna, British Columbia, Canada




Dr. Sundeep Singh, Inc /ID# 254250

Kelowna, British Columbia, V1Y 6J6

Fraser Clinical Trials Inc /ID# 254512, New Westminster, British Columbia, Canada




Fraser Clinical Trials Inc /ID# 254512

New Westminster, British Columbia, V3L 3W4

North Bay, Ontario, Canada




Scott Shulman Medicine Professional Corporation /ID# 252961

North Bay, Ontario, P1B 2H3

Taunton Surgical Centre /ID# 253812, Oshawa, Ontario, Canada




Taunton Surgical Centre /ID# 253812

Oshawa, Ontario, L1H 7K4