RECRUITINGOBSERVATIONAL

Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis

A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Participants previously exposed risankizumab - Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Locations (20)

Universitaetsklinikum Heidelberg /ID# 275906

Heidelberg, Baden-Wurttemberg, Germany

Klinikum Ernst Von Bergmann /ID# 278268

Potsdam, Brandenburg, Germany

Private Practice - Dr. Kempelmann /ID# 275726

Tostedt, Hamburg, Germany

Gastroenterologische Schwerpunktpraxis /ID# 276701

Hanover, Lower Saxony, Germany

Medizinisches Versorgungszentrum Ahaus /ID# 280966

Ahaus, North Rhine-Westphalia, Germany

Gastropraxis Bochum /ID# 281375

Bochum, North Rhine-Westphalia, Germany

Katholisches Klinikum Bochum gGmbH /ID# 279486

Bochum, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Kalk /ID# 276414

Cologne, North Rhine-Westphalia, Germany

Dres. Kamp & Partner /ID# 275904

Minden, North Rhine-Westphalia, Germany

Gemeinschaftspraxis Innere Medizin /ID# 280068

Witten, North Rhine-Westphalia, Germany

Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943

Koblenz, Rhineland-Palatinate, Germany

Gastroenterologische Schwerpunkt Praxis /ID# 279856

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Private Practice - Dr. Johannes Janschek /ID# 275877

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig /ID# 276779

Leipzig, Saxony, Germany

Gesellschaft für klinische Studien /ID# 275867

Leipzig, Saxony, Germany

Private Practice - Dr. Thomas Zeisler /ID# 277933

Halle, Saxony-Anhalt, Germany

Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905

Halle, Saxony-Anhalt, Germany

Praxisgemeinschaft Jerichow Schulze /ID# 275911

Jerichow, Saxony-Anhalt, Germany

Private Practice - Dr. Jaqueline Schumann /ID# 276126

Teuchern, Saxony-Anhalt, Germany

Gemeinschaftspraxis im Medicum /ID# 275933

Altenholz, Schleswig-Holstein, Germany