Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's Disease

Ulcerative Colitis Clinical Trial

Official title:

Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459297
• Other study ID #: P24-081
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: KyungJoo Kim
• Phone: +82-10-3221-0662
• Email: kyungjoo.kim[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea.

Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Participants diagnosis with ulcerative colitis or Crohn's Disease suitable for the treatment with Upadacitinib.

• Participants prescribed upadacitinib in accordance with the approved local label.

Exclusion Criteria:

• Participants with any contraindication to Upadacitinib.

• Participants currently participating in another clinical research not including observational study.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who reported Serious Adverse Event	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 52 weeks
Primary	Percentage of participants who reported Serious Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Primary	Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Primary	Percentage of participants who reported known (labeled) Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Primary	Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks
Primary	Percentage of participants who reported the events related to important identified risks/important potential risks/missing information	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.	Up to 52 weeks

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