Clinical trial NCT06459297: Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Inflammatory Bowel Diseases
Upadacitinib
RINVOQ
Ulcerative colitis
Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-06-14
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with ulcerative colitis or Crohn's Disease

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants who reported Serious Adverse Event
timeFrame: Up to 52 weeks
measure: Percentage of participants who reported Serious Adverse Drug Reaction
timeFrame: Up to 52 weeks
measure: Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction
timeFrame: Up to 52 weeks
measure: Percentage of participants who reported known (labeled) Adverse Drug Reaction
timeFrame: Up to 52 weeks
measure: Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction
timeFrame: Up to 52 weeks
measure: Percentage of participants who reported the events related to important identified risks/important potential risks/missing information
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cheonan-si
country: Korea, Republic of
facility: SoonChunHyang University Hospital Cheonan /ID# 270015
state: Chungcheongnamdo
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
state: Daejeon Gwang Yeogsi
city: 고양시
country: Korea, Republic of
facility: Inje University - Ilsan Paik Hospital /ID# 269995
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 269775
state: Gyeongsangbugdo
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital /ID# 269990
state: Jeonranamdo
city: Dongdaemun-gu
country: Korea, Republic of
facility: Kyung Hee University Hospital /ID# 270003
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 268865
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 270020
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 270013
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Centre /ID# 269776
state: Seoul Teugbyeolsi
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital /ID# 270006
state: Ulsan Gwang Yeogsi
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center /ID# 269992
city: 중구
country: Korea, Republic of
facility: Seoul Songdo Hospital /ID# 270009
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: