An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK) (COMMODUS)

AbbVie

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT06126146

P24-171

Details and patient eligibility

About

Crohn's Disease (CD) is a chronic condition that causes inflammation of the gastrointestinal tract or gut. This study will assess real-world, adult participant experience of self-injection with the risankizumab OBI.

Risankizumab is an approved drug for the treatment of CD in adults. Approximately 80 participants who are prescribed risankizumab by their doctors and are transitioning from the pre-filled syringe (PFS) to the use of OBI will be enrolled in this study in the United Kingdom (UK).

Participants will receive risankizumab OBI as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 6 months.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site, at home, or virtually as per standard of care.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older
• Eligible for and received risankizumab for maintenance treatment of Crohn's Disease (CD) through United Kingdom (UK) Early Access to Medicines Scheme (EAMS)/Pre-Approval Access (PAA) schemes
• The decision to treat with risankizumab was made independently, in line with usual clinical practice, marketing authorisation and prior to enrolment in the study
• Exits UK EAMS/PAA and switches from risankizumab pre-filled syringe (PFS) to on-body injector (OBI)
• Can physically self-administer risankizumab OBI without carer assistance
• Can read and understand English
• Willing and able to provide voluntary informed consent
• Able and willing to participate in this study.

Exclusion criteria

N/A

Trial design

53 participants in 1 patient group

Risankizumab

Description:

Participants will receive risankizumab on-body injector (OBI) as prescribed by their physician according to local label.