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

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ClinicalTrials.gov Identifier: NCT03942120
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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 Intervention/treatment
Crohn Disease Drug: Ustekinumab

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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 8, 2019
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : April 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

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 Name: Stelara




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).



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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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942120


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

Locations
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Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 48108
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of, 48108
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 42415
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 03181
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
KyungHee University Hospital Recruiting
Seoul, Korea, Republic of, 102-1703
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Additional Information:
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT03942120     History of Changes
Other Study ID Numbers: CR108610
CNTO1275CRD4029 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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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:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents