Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
- Registration Number
- NCT03942120
- Lead Sponsor
- Janssen Korea, Ltd., Korea
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 685
- 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
- Have contraindication to Stelara in accordance to the label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Crohn's Disease Ustekinumab Participants that are diagnosed with Crohn's disease will be observed in this study who are being treated with ustekinumab under real world clinical practice. Only data available per clinical practice will be collected within this study.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events Approximately up to 3 years 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.
Change from Baseline in Crohn's Disease Activity Index (CDAI) Score Baseline up to 3 years 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.
Change from Baseline in C-reactive Protein (CRP) Concentration Baseline up to 3 years Change from baseline in CRP concentration will be assessed.
Change from Baseline in Harvey-Bradshaw Index (HBI) Score Baseline up to 3 years 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).
Change from Baseline in Fecal Calprotectin Level Baseline up to 3 years 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.
Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Baseline up to 3 years 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 \[the most severe endoscopic activity\]).
Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score Baseline up to 3 years 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
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
The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital
🇰🇷Seongnam, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Severance Hospital - Dept.of Internal Medicine
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Woman's University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Mary s Hospital
🇰🇷Seoul, 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
Good Gangan Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Changwon Kyunngsang University Hospital
🇰🇷Changwonsi, Korea, Republic of
Samsung ChangWon Hospital
🇰🇷ChangWon, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan-si, Korea, Republic of
Soonchunhyang University Cheonan Hospital
🇰🇷Cheonan, 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
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
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Koo Hospital
🇰🇷Daegu, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Chunnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of