Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)

Crohn Disease Clinical Trial

— STELARA CD PMS  

Official title:

Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942120
• Other study ID #: CR108610
• Secondary ID: CNTO1275CRD4029
• Status: Completed
• Start date: April 8, 2019
• Est. completion date: January 14, 2022

Study information

• Verified date: March 2023
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Ustekinumab
Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Good Gangan Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Samsung ChangWon Hospital	ChangWon
Korea, Republic of	Changwon Kyunngsang University Hospital	Changwonsi
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Dankook University Hospital	Cheonan-si
Korea, Republic of	Hallym University Chuncehon Medical Center	ChunCheon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Daegu Fatima Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Koo Hospital	Daegu
Korea, Republic of	Kyongpook national university Medical center	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chunnam National University Hospital	Gwangju
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsangnam-do
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si
Korea, Republic of	GyeongSang National University Hospital	Jinju
Korea, Republic of	Bucheon Soonchunhyang Hospital	Kyunggido
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam
Korea, Republic of	The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Ewha Woman's University Seoul Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital - Dept.of Internal Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Approximately up to 3 years
Primary	Change from Baseline in Crohn's Disease Activity Index (CDAI) Score	CDAI is a scoring system to assess the symptoms of participants with Crohn's disease (CD). It consists of 8 different CD-related factors that are summed after adjustment with a weighting factor. These 8 variables are: extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid stools, abdominal pain/cramping, and general well-being. CDAI total score ranges from 0 to 900 and a decrease over time indicates improvement in disease activity.	Baseline up to 3 years
Primary	Change from Baseline in C-reactive Protein (CRP) Concentration	Change from baseline in CRP concentration will be assessed.	Baseline up to 3 years
Primary	Change from Baseline in Harvey-Bradshaw Index (HBI) Score	HBI is a shorter and simpler alternative version of CDAI which consists of five parameters that allow physicians to quickly categorize the severity of Crohn's disease and detect remission. The 5 parameters are: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day (score 1 per movement), abdominal mass (0=none, 1=dubious, 2=definite, 3=definite and tender), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicate more severe disease and, score is presented as: less than (<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (>)16 (severe disease).	Baseline up to 3 years
Primary	Change from Baseline in Fecal Calprotectin Level	Change from baseline in fecal calprotectin levels will be assessed. Elevated calprotectin level in the stool indicates that inflammation is present in the intestine and the degree of elevation is associated with the severity of the inflammation.	Baseline up to 3 years
Primary	Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)	SES-CD is a simplified endoscopic scoring system to evaluate Crohn's disease activity developed as an alternative to Crohn's disease endoscopic index of severity (CDEIS). It assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence stenosis. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 60 [the most severe endoscopic activity]).	Baseline up to 3 years
Primary	Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score	SIBDQ is a simple, validated 10-item self-reported questionnaire for participants with inflammatory bowel disease to evaluate participant-reported outcomes in 4 domains- digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbance (3 items), and social function (2 items). Participants rate each item on a 7-point Likert scale (1=all of the time; 2=most of the time; 3=a good bit of the time; 4=some of the time; 5=a little bit of the time; 6=hardly any of the time; 7=none of the time). Total score is calculated by adding the scores from each domain; the total score ranges from 10 to 70, where minimum score =10 (poor quality of life) and maximum score =70 (good quality of life).	Baseline up to 3 years