RecruitingNCT06764706

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)

Sponsor

AbbVie

Enrollment

200 participants

Start Date

Feb 27, 2025

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria2

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(55)

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

Praxis S. Tetzlaff /ID# 275882

Buedelsdorf, Schleswig-Holstein, Germany

Praxis Dr. Guenther-Tritsch /ID# 275886

Geesthacht, Schleswig-Holstein, Germany

Diabetologie Dithmarschen /ID# 281104

Heide, Schleswig-Holstein, Germany

Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931

Kiel, Schleswig-Holstein, Germany

Praxis fuer Gastroenterologie /ID# 275903

Lübeck, Schleswig-Holstein, Germany

Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105

Neumünster, Schleswig-Holstein, Germany

Dr. Jack Peter-Stein /ID# 276815

Jena, Thuringia, Germany

Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072

Nordhausen, Thuringia, Germany

Praxis Heil & Mueller /ID# 275927

Andernach, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884

Berlin, Germany

Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966

Berlin, Germany

Private Practice- Dr. Andreas Horn /ID# 281448

Berlin, Germany

Gastroenterologie im Mühlenbergviertel /ID# 275883

Berlin, Germany

Dres. Schick/Wesenberg /ID# 275878

Berlin, Germany

Gastro Studien GbR /ID# 275920

Berlin, Germany

Drk Kliniken Berlin - Köpenick /ID# 276277

Berlin, Germany

Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089

Berlin, Germany

Praxis Dr. Soellenboehmer /ID# 276183

Berlin, Germany

Krankenhaus Waldfriede /ID# 275913

Berlin, Germany

Praxis Dr. Spitz /ID# 275912

Berlin, Germany

Universitaetsklinikum Duesseldorf /ID# 280409

Düsseldorf, Germany

Dres. Bauer/Doerflinger /ID# 276093

Freiburg im Breisgau, Germany

Private Practice - Dr. Matthias Eichler /ID# 275875

Hamburg, Germany

Gastroenterologie Rahlstedt /ID# 276408

Hamburg, Germany

GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874

Herne, Germany

Gastroenterologe am Ettlinger Tor /ID# 279854

Karlsruhe, Germany

Dres. Breitschwerdt/Glas/Gurtler /ID# 276057

Leipzig, Germany

MVZ Gastroenterologie Leverkusen /ID# 275901

Leverkusen, Germany

Gastropraxis Magdeburg /ID# 275885

Magdeburg, Germany

Bettenworth & Partner /ID# 275900

Münster, Germany

Pc Docs /Id# 275876

Pirmasens, Germany

Praxis fuer Gastroenterologie /ID# 275946

Schwerin, Germany

Dres. Rehbehn/Skusa /ID# 276090

Solingen, Germany

Private Practice - Dr. Markus Braunfels /ID# 277129

Wesseling, Germany

Dr. Schirin-Sokhan /ID# 276982

Würselen, Germany

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NCT06764706

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