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)
NCT06126146 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53
Last updated 2025-06-29
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.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-26
- Primary Completion
- 2024-05-16
- Completion
- 2024-05-16
Countries
- United Kingdom
Study Locations
More Related Trials
-
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
NCT06063967 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
NCT03104413 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
NCT03105128 ·Status: COMPLETED ·Phase: PHASE3
-
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
NCT02513459 ·Status: COMPLETED ·Phase: PHASE2
-
Expanded Access to Risankizumab
NCT03914261 ·Status: NO_LONGER_AVAILABLE
-
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
NCT04254783 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
NCT07242248 ·Status: RECRUITING
-
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
NCT06606808 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
NCT06764706 ·Status: RECRUITING
-
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
NCT00207662 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
NCT04877990 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
NCT06456593 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
NCT02877134 ·Status: COMPLETED ·Phase: PHASE2
-
An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease
NCT03362736 ·Status: NO_LONGER_AVAILABLE
-
A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting
NCT07073079 ·Status: RECRUITING
-
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
NCT07136116 ·Status: RECRUITING
-
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
NCT01218360 ·Status: COMPLETED
-
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
NCT00269841 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
NCT01461317 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease
NCT01635621 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT05995353 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis
NCT01658605 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
NCT01369329 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
NCT00207766 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
NCT00656890 ·Status: COMPLETED ·Phase: PHASE2