Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)
Overview
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice. Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria. 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 52 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Primary outcome measures
- Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score [Time frame: Up to approximately 52 weeks]
Eligibility criteria
Inclusion criteria
- Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.
- Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.
Exclusion criteria
- Participants previously exposed risankizumab
- Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 56 centers
- Universitaetsklinikum Heidelberg /ID# 275906 — Heidelberg
- Klinikum Ernst Von Bergmann /ID# 278268 — Potsdam
- Private Practice - Dr. Kempelmann /ID# 275726 — Tostedt
- Gastroenterologische Schwerpunktpraxis - Hannover /ID# 276701 — Hanover
- Praxis fuer Gastroenterologie - Schwerin /ID# 275946 — Schwerin
- Medizinisches Versorgungszentrum Ahaus /ID# 280966 — Ahaus
- Gastropraxis Bochum /ID# 281375 — Bochum
- Katholisches Klinikum Bochum gGmbH /ID# 279486 — Bochum
- … and 48 more centers
Identifiers
NCT: NCT06764706 · P25-544