Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium

NCT06581042 | Recruiting

• 1 other identifier: P24-960
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 7

Brief Summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD). Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. 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

Conditions

Ulcerative Colitis; Crohn's Disease

Keywords

Ulcerative colitis; Crohn's disease; Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis

  Clinical remission is defined as: stool frequency (SF) score \< = 1 and not greater than baseline and Rectal bleeding (RB) score = 0

  Up to approximately 52 weeks

• Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease

  Clinical remission is defined as stool frequency (SF) score \< =3 and not worse than baseline and Abdominal Pain (AP) score \< =1 and not worse than baseline

  Up to approximately 52 weeks

Study Arms (1)

Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with ulcerative colitis or Crohn's Disease

You may qualify if:

• Participants initiating commercially available upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study
• Participants prescribed upadacitinib in accordance with the approved local label and treatment recommendations

You may not qualify if:

• Participants previously exposed to upadacitinib in a clinical trial or early access program
• Participants participating in interventional research (not including non-interventional
• Participants with stoma

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

Imelda Ziekenhuis /ID# 268631

Bonheiden, Antwerpen, 2820, Belgium

RECRUITING

Universite Libre de Bruxelles - Hopital Erasme /ID# 268632

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

CHU de Liège /ID# 267209

Liège, Liege, 4000, Belgium

RECRUITING

UZ Gent /ID# 268630

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Vitaz /Id# 268637

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

RECRUITING

AZ Groeninge /ID# 268638

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

Groupe Sante CHC - Clinique du MontLegia /ID# 268662

Liège, 4000, Belgium

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Liesbeth Ghys

CONTACT

844-663-3742; liesbeth.ghys@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

BE (7)