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)

Last updated: May 31, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Crohn's Disease

Inflammatory Bowel Disease

Colic

Treatment

N/A

Clinical Study ID

NCT06126146
P24-171
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 usualclinical practice, marketing authorisation and prior to enrolment in the study

  • Exits UK EAMS/PAA and switches from risankizumab pre-filled syringe (PFS) to on-bodyinjector (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

Exclusion Criteria:

N/A

Study Design

Total Participants: 53
Study Start date:
October 26, 2023
Estimated Completion Date:
May 16, 2024

Connect with a study center

  • University Hospital Southampton NHS Foundation Trust /ID# 258989

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust /ID# 258986

    London, London, City Of SE1 9RT
    United Kingdom

    Site Not Available

  • NHS Lothian /ID# 260901

    Edinburgh, EH3 9HE
    United Kingdom

    Site Not Available

  • The Royal London Hospital /ID# 259047

    London, E1 1BB
    United Kingdom

    Site Not Available

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260902

    Newcastle upon Tyne, NE3 3HD
    United Kingdom

    Site Not Available

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