Assessing the effects of risankizumab on ulcerative colitis in adults
A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)
This study is testing how well risankizumab works for adults with moderate to severe ulcerative colitis by looking at their progress over a year while they receive the treatment from their doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | risankizumab |
| Locations | 55 sites (Heidelberg, Baden-Wurttemberg and 54 other locations) |
| Trial ID | NCT06764706 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of risankizumab in treating adult patients with moderate to severe ulcerative colitis in real-world clinical settings. Approximately 200 participants will be enrolled across multiple sites in Germany and Austria, receiving risankizumab as prescribed by their physicians. The study will monitor changes in disease activity over a period of up to 52 weeks, with no additional burden placed on participants beyond their routine clinical visits.
Who should consider this trial
Good fit: Ideal candidates are adults with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis who are initiating treatment with risankizumab.
Not a fit: Patients who have previously been treated with risankizumab or are currently involved in interventional research may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of risankizumab for managing ulcerative colitis.
How similar studies have performed: Other studies have shown success with similar observational approaches in assessing treatment effectiveness for ulcerative colitis, making this a relevant and potentially impactful investigation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Heidelberg, Baden-Wurttemberg and 54 other locations
- Universitaetsklinikum Heidelberg /ID# 275906 — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Klinikum Ernst Von Bergmann /ID# 278268 — Potsdam, Brandenburg, Germany (Recruiting)
- Private Practice - Dr. Kempelmann /ID# 275726 — Tostedt, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Gastroenterologische Schwerpunktpraxis /ID# 276701 — Hanover, Lower Saxony, Germany (Recruiting)
- Medizinisches Versorgungszentrum Ahaus /ID# 280966 — Ahaus, North Rhine-Westphalia, Germany (Recruiting)
- Gastropraxis Bochum /ID# 281375 — Bochum, North Rhine-Westphalia, Germany (Recruiting)
- Katholisches Klinikum Bochum gGmbH /ID# 279486 — Bochum, North Rhine-Westphalia, Germany (Recruiting)
- Evangelisches Krankenhaus Kalk /ID# 276414 — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Dres. Kamp & Partner /ID# 275904 — Minden, North Rhine-Westphalia, Germany (Recruiting)
- Gemeinschaftspraxis Innere Medizin /ID# 280068 — Witten, North Rhine-Westphalia, Germany (Recruiting)
- Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943 — Koblenz, Rhineland-Palatinate, Germany (Recruiting)
- Gastroenterologische Schwerpunkt Praxis /ID# 279856 — Ludwigshafen am Rhein, Rhineland-Palatinate, Germany (Recruiting)
- Private Practice - Dr. Johannes Janschek /ID# 275877 — Dresden, Saxony, Germany (Recruiting)
- Universitaetsklinikum Leipzig /ID# 276779 — Leipzig, Saxony, Germany (Recruiting)
- Gesellschaft für klinische Studien /ID# 275867 — Leipzig, Saxony, Germany (Recruiting)
- Private Practice - Dr. Thomas Zeisler /ID# 277933 — Halle, Saxony-Anhalt, Germany (Recruiting)
- Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905 — Halle, Saxony-Anhalt, Germany (Recruiting)
- Praxisgemeinschaft Jerichow Schulze /ID# 275911 — Jerichow, Saxony-Anhalt, Germany (Recruiting)
- Private Practice - Dr. Jaqueline Schumann /ID# 276126 — Teuchern, Saxony-Anhalt, Germany (Recruiting)
- Gemeinschaftspraxis im Medicum /ID# 275933 — Altenholz, Schleswig-Holstein, Germany (Recruiting)
- Praxis S. Tetzlaff /ID# 275882 — Buedelsdorf, Schleswig-Holstein, Germany (Recruiting)
- Praxis Dr. Guenther-Tritsch /ID# 275886 — Geesthacht, Schleswig-Holstein, Germany (Recruiting)
- Diabetologie Dithmarschen /ID# 281104 — Heide, Schleswig-Holstein, Germany (Recruiting)
- Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931 — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Praxis fuer Gastroenterologie /ID# 275903 — Lübeck, Schleswig-Holstein, Germany (Recruiting)
- Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105 — Neumünster, Schleswig-Holstein, Germany (Recruiting)
- Dr. Jack Peter-Stein /ID# 276815 — Jena, Thuringia, Germany (Recruiting)
- Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072 — Nordhausen, Thuringia, Germany (Recruiting)
- Praxis Heil & Mueller /ID# 275927 — Andernach, Germany (Recruiting)
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884 — Berlin, Germany (Recruiting)
- Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966 — Berlin, Germany (Recruiting)
- Private Practice- Dr. Andreas Horn /ID# 281448 — Berlin, Germany (Recruiting)
- Gastroenterologie im Mühlenbergviertel /ID# 275883 — Berlin, Germany (Recruiting)
- Dres. Schick/Wesenberg /ID# 275878 — Berlin, Germany (Recruiting)
- Gastro Studien GbR /ID# 275920 — Berlin, Germany (Recruiting)
- Drk Kliniken Berlin - Köpenick /ID# 276277 — Berlin, Germany (Recruiting)
- Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089 — Berlin, Germany (Recruiting)
- Praxis Dr. Soellenboehmer /ID# 276183 — Berlin, Germany (Recruiting)
- Krankenhaus Waldfriede /ID# 275913 — Berlin, Germany (Recruiting)
- Praxis Dr. Spitz /ID# 275912 — Berlin, Germany (Recruiting)
- Universitaetsklinikum Duesseldorf /ID# 280409 — Düsseldorf, Germany (Recruiting)
- Dres. Bauer/Doerflinger /ID# 276093 — Freiburg im Breisgau, Germany (Recruiting)
- Private Practice - Dr. Matthias Eichler /ID# 275875 — Hamburg, Germany (Recruiting)
- Gastroenterologie Rahlstedt /ID# 276408 — Hamburg, Germany (Recruiting)
- GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874 — Herne, Germany (Recruiting)
- Gastroenterologe am Ettlinger Tor /ID# 279854 — Karlsruhe, Germany (Recruiting)
- Dres. Breitschwerdt/Glas/Gurtler /ID# 276057 — Leipzig, Germany (Recruiting)
- MVZ Gastroenterologie Leverkusen /ID# 275901 — Leverkusen, Germany (Recruiting)
- Gastropraxis Magdeburg /ID# 275885 — Magdeburg, Germany (Recruiting)
- Bettenworth & Partner /ID# 275900 — Münster, Germany (Recruiting)
+5 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Medical Information Germany
- Email: medinfo.germany@abbvie.com
- Phone: 49 611 1720 1520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.