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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

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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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    15 and up

Critères de 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.

Lieu de l'étude

Gastroenterology and Internal Medicine Research Institution /ID# 253319
Gastroenterology and Internal Medicine Research Institution /ID# 253319
Edmonton, Alberta
Canada

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

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Scott Shulman Medicine Professional Corporation /ID# 252961
Scott Shulman Medicine Professional Corporation /ID# 252961
North Bay, Ontario
Canada

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Toronto Digestive Disease Associates /ID# 253813
Toronto Digestive Disease Associates /ID# 253813
Vaughan, Ontario
Canada

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CIUSSS de l'Estrie - CHUS /ID# 254591
CIUSSS de l'Estrie - CHUS /ID# 254591
Sherbrooke, Quebec
Canada

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University of Calgary /ID# 254511
University of Calgary /ID# 254511
Calgary, Alberta
Canada

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

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Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661
Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661
Hamilton, Ontario
Canada

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Primary Contact

Site Coordinator

9055212100
Taunton surgical centre /ID# 253812
Taunton surgical centre /ID# 253812
Oshawa, Ontario
Canada

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Diex Recherche Québec Inc. /ID# 254016
Diex Recherche Québec Inc. /ID# 254016
Québec, Quebec
Canada

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South Edmonton Gastroenterology Research Clinic /ID# 253160
South Edmonton Gastroenterology Research Clinic /ID# 253160
Edmonton, Alberta
Canada

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Primary Contact

Site Coordinator

7802449210
Percuro Clinical Research, Ltd /ID# 256339
Percuro Clinical Research, Ltd /ID# 256339
Victoria, British Columbia
Canada

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Physician's Clinical Research Inc. /ID# 256494
Physician's Clinical Research Inc. /ID# 256494
North York, Ontario
Canada

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CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522
Montreal, Quebec
Canada

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Six08 Gastroenterology /ID# 254513
Six08 Gastroenterology /ID# 254513
Lethbridge, Alberta
Canada

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The Moncton Hospital /ID# 252960
The Moncton Hospital /ID# 252960
Moncton, New Brunswick
Canada

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Toronto Immune and Digestive Health Institute Inc /ID# 253946
Toronto Immune and Digestive Health Institute Inc /ID# 253946
North York, Ontario
Canada

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Royal Victoria Hospital / McGill University Health Centre /ID# 254626
Royal Victoria Hospital / McGill University Health Centre /ID# 254626
Montreal, Quebec
Canada

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Diex Recherche Québec /ID# 254016
Diex Recherche Québec /ID# 254016
Québec, Quebec
Canada

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Étude parrainée par
AbbVie
Participants recherchés
Plus d'informations
ID de l'étude: NCT05841537