Clinical trial NCT03942120: Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
Official title: Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eligible participants who are being prescribed ustekinumab (Stelara) for the treatment of Crohn's disease indication will be part of this study.

Brief summary: The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice.


Eligibility criteria: Inclusion Criteria:

* Participants who are administered with Stelara for the first time for the indication of Crohn's disease in accordance with the label
* Participants must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

- Have contraindication to Stelara in accordance to the label

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Approximately up to 3 years
measure: Change from Baseline in Crohn's Disease Activity Index (CDAI) Score
timeFrame: Baseline up to 3 years
measure: Change from Baseline in C-reactive Protein (CRP) Concentration
timeFrame: Baseline up to 3 years
measure: Change from Baseline in Harvey-Bradshaw Index (HBI) Score
timeFrame: Baseline up to 3 years
measure: Change from Baseline in Fecal Calprotectin Level
timeFrame: Baseline up to 3 years
measure: Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: Baseline up to 3 years
measure: Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
timeFrame: Baseline up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Good Gangan Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Changwonsi
country: Korea, Republic of
facility: Changwon Kyunngsang University Hospital
city: ChangWon
country: Korea, Republic of
facility: Samsung ChangWon Hospital
city: Cheonan-si
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: ChunCheon
country: Korea, Republic of
facility: Hallym University Chuncehon Medical Center
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Kyongpook national university Medical center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Koo Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chunnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Jinju
country: Korea, Republic of
facility: GyeongSang National University Hospital
city: Kyunggido
country: Korea, Republic of
facility: Bucheon Soonchunhyang Hospital
city: Seongnam
country: Korea, Republic of
facility: The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital - Dept.of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Woman's University Seoul Hospital
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: