APPRISE

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

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.

Observational study

Status:
Recruiting
Conditions:
Crohn's Disease
Enrollment:
1000 patients
Protocol ID:
P22-920
Observational model:
Cohort
Time perspective:
Prospective

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
Yes, please contact me

Eligibility criteria

Participant attributes:
Male and Female

Age:

15 Years and older.

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.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5R 1W2
Edmonton - T6K 4B2
Lethbridge - T1J 4G9
Kelowna - V1Y 6J6
New Westminster - V3L 3W4
Victoria - V8V 3M9
Hamilton - L8S 4K1
North Bay - P1B 2H3
North York - M2K 2W2
North York - M6A 3B4
Oshawa - L1H 7K4
Vaughan - L4L 4Y7
Montreal - H1T 2M4
Montreal - H4A 3J1
Québec - G1V 4T3
Moncton - E1C 6Z8