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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Ustekinumab

• Study Type: Observational
• Enrollment (Actual): 685

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of, 48108
    • Kosin University Gospel Hospital
  • Busan, Korea, Republic of, 48265
    • Good Gangan Hospital
  • Busan, Korea, Republic of, 602-812
    • Dong-A University Hospital
  • ChangWon, Korea, Republic of, 51353
    • Samsung Changwon Hospital
  • Changwonsi, Korea, Republic of, 51472
    • Changwon Kyunngsang University Hospital
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Cheonan Hospital
  • Cheonan-si, Korea, Republic of, 31116
    • Dankook University Hospital
  • ChunCheon, Korea, Republic of, 24253
    • Hallym University Chuncehon Medical Center
  • Chuncheon, Korea, Republic of, 24289
    • Kangwon National University Hospital
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Hospital
  • Daegu, Korea, Republic of, 41199
    • Daegu fatima hospital
  • Daegu, Korea, Republic of, 41404
    • Kyongpook national university Medical center
  • Daegu, Korea, Republic of, 42644
    • Koo Hospital
  • Daejeon, Korea, Republic of, 302-718
    • Konyang University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of, 501-757
    • Chunnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Gyeongsangnam-do, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Hwaseong-si, Korea, Republic of, 18450
    • Hallym University Dongtan Sacred Heart Hospital
  • Jinju, Korea, Republic of, 52727
    • Gyeongsang National University Hospital
  • Kyunggido, Korea, Republic of
    • Bucheon Soonchunhyang Hospital
  • Seongnam, Korea, Republic of, 13620
    • The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital
  • Seongnam, Korea, Republic of, 412-723
    • CHA Bundang Medical Center, CHA University
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 135-720
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 102-1703
    • KyungHee University Hospital
  • Seoul, Korea, Republic of, 02447
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of, 04401
    • SoonChunHyang University Seoul Hospital
  • Seoul, Korea, Republic of, 06351
    • Hallym University Medical Center
  • Seoul, Korea, Republic of, 120752
    • Yonsei University Severance Hospital - Dept.of Internal Medicine
  • Seoul, Korea, Republic of, 158-710
    • Ewha Woman's University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.; Other Names: Stelara

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: CR108610; CNTO1275CRD4029 (Other Identifier: Janssen Korea, Ltd., Korea)

Drug and device information, study documents

• 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