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

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT03942120

Acronym / sponsor ID

STELARA CD PMS / CR108610

Conditions

Crohn Disease

Study type

Observational

Recruitment status

Completed

Enrolment

685 participants (actual)

Lead sponsor

Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)

Study start

8 Apr 2019 (actual)

Primary completion

14 Jan 2022 (actual)

Study completion

14 Jan 2022 (actual)

First posted

8 May 2019 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants with Adverse Events

   Time frame: 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.

2. Change from Baseline in Crohn's Disease Activity Index (CDAI) Score

   Time frame: 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.

3. Change from Baseline in C-reactive Protein (CRP) Concentration

   Time frame: Baseline up to 3 years

   Change from baseline in CRP concentration will be assessed.

4. Change from Baseline in Harvey-Bradshaw Index (HBI) Score

   Time frame: 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).

5. Change from Baseline in Fecal Calprotectin Level

   Time frame: 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.

6. Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)

   Time frame: 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]).

7. Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

   Time frame: 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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
• Derived from this study: PubMed 39096895Lee CK, Moon W, Chun J, Kim ES, Kim HW, Yoon H, Kim HS, Lee YJ, Choi CH, Jung Y, Park SC, Song GA, Lee JH, Jung ES, Kim Y, Jung SY, Choi JM, Ye BD. One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study. Inflamm Bowel Dis. 2025 May 12;31(5):1306-1316. doi: 10.1093/ibd/izae171.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

43 sites in 1 country: see every site and its status.