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An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

NCT05494606 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 785

Last updated 2025-02-28

No results posted yet for this study

Summary

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.

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

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Argentina
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Kuwait
  • Portugal
  • Qatar
  • Russia
  • Spain
  • United Arab Emirates
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494606 on ClinicalTrials.gov