Crohn Disease
Conditions
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.
Interventions
DRUGUstekinumab
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.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
South Korea
Outcome results
None listed