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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03942120

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted September 30, 2020

Study Description

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.

  • Condition or Disease:Crohn Disease
  • Intervention/Treatment: Drug: Ustekinumab
  • Phase: N/A
Detailed Description


Study Design
  • Study Type: Observational
  • Estimated Enrollment: 70 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: November 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Participants with Crohn's Disease
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.
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.
Outcome Measures
  • Primary Outcome Measures: 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).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.

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

Contacts and Locations

Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Show 37 Study Locations
Sponsors and Collaborators

Janssen Korea, Ltd., Korea


Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

More Information
  • Responsible Party: Janssen Korea, Ltd., Korea
  • ClinicalTrials.gov Identifier: NCT03942120 History of Changes
  • Other Study ID Numbers: CR108610, CNTO1275CRD4029
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: September 30, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Crohn Disease