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

NCT03942120 | Completed FDA Drug

• 2 other identifiers: CR108610CNTO1275CRD4029
• Study Type: observational
• Target: 685
• Locations: 1 country
• Sites: 43

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (7)

• 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

• 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

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

  Change from baseline in CRP concentration will be assessed.

  Baseline up to 3 years

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

Ustekinumab DRUG

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.

Also known as: Stelara

Participants with Crohn's Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Have contraindication to Stelara in accordance to the label

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (43)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Kosin University Gospel Hospital

Busan, 48108, South Korea

Location

Good Gangan Hospital

Busan, 48265, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Dong-A University Hospital

Busan, 602 812, South Korea

Location

Samsung ChangWon Hospital

Changwon, 51353, South Korea

Location

Changwon Kyunngsang University Hospital

Changwonsi, 51472, South Korea

Location

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

Location

Dankook University Hospital

Cheonan-si, 31116, South Korea

Location

Hallym University Chuncehon Medical Center

Chuncheon, 24253, South Korea

Location

Kangwon National University Hospital

Chuncheon, 24289, South Korea

Location

Daegu Fatima Hospital

Daegu, 41199, South Korea

Location

Kyongpook national university Medical center

Daegu, 41404, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Koo Hospital

Daegu, 42644, South Korea

Location

Konyang University Hospital

Daejeon, 302-718, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chunnam National University Hospital

Gwangju, 501-757, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, 18450, South Korea

Location

GyeongSang National University Hospital

Jinju, 52727, South Korea

Location

Bucheon Soonchunhyang Hospital

Kyunggido, South Korea

Location

The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital

Seongnam, 13620, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam, 412-723, South Korea

Location

Pusan National University Yangsan Hospital

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, 04401, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hallym University Medical Center

Seoul, 06351, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

KyungHee University Hospital

Seoul, 102-1703, South Korea

Location

Yonsei University Severance Hospital - Dept.of Internal Medicine

Seoul, 120752, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Ewha Woman's University Seoul Hospital

Seoul, 158-710, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Related Publications (1)

• Lee 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.

  PMID: 39096895 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: April 8, 2019
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

KR (43)