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

Recruiting

• Conditions: Ulcerative Colitis; Crohn's Disease

• Registration Number: NCT06459297
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Study Start: 2024-06-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants who reported the events related to important identified risks/important potential risks/missing information	Up to 52 weeks	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.
Percentage of participants who reported Serious Adverse Event	Up to 52 weeks	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.
Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction	Up to 52 weeks	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.
Percentage of participants who reported Serious Adverse Drug Reaction	Up to 52 weeks	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.
Percentage of participants who reported known (labeled) Adverse Drug Reaction	Up to 52 weeks	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.
Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction	Up to 52 weeks	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.

Trial Locations

Locations (14)

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

SoonChunHyang University Hospital Cheonan /ID# 270015; 🇰🇷 Cheonan-si, Chungcheongnamdo, Korea, Republic of

The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843; 🇰🇷 Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of

Inje University - Ilsan Paik Hospital /ID# 269995; 🇰🇷 고양시, Gyeonggido, Korea, Republic of

Keimyung University Dongsan Hospital /ID# 269775; 🇰🇷 Daegu, Gyeongsangbugdo, Korea, Republic of

Chosun University Hospital /ID# 269990; 🇰🇷 Gwangju, Jeonranamdo, Korea, Republic of

Kyung Hee University Hospital /ID# 270003; 🇰🇷 Dongdaemun-gu, Seoul Teugbyeolsi, Korea, Republic of

Yonsei University Health System Severance Hospital /ID# 268865; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Gangnam Severance Hospital /ID# 270020; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital /ID# 270013; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Ewha Womans University Medical Centre /ID# 269776; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Ulsan University Hospital /ID# 270006; 🇰🇷 Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of

Yeungnam University Medical Center /ID# 269992; 🇰🇷 Daegu, Korea, Republic of

Seoul Songdo Hospital /ID# 270009; 🇰🇷 중구, Korea, Republic of