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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 April 2023 |
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Main ID: |
NCT03942120 |
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Date of registration:
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07/05/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
STELARA CD PMS |
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Scientific title:
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Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA |
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Date of first enrolment:
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April 8, 2019 |
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Target sample size:
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685 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03942120 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Janssen Korea, Ltd., Korea Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Korea, Ltd., Korea |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Ustekinumab
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Primary Outcome(s)
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Change from Baseline in Fecal Calprotectin Level
[Time Frame: Baseline up to 3 years]
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Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)
[Time Frame: Baseline up to 3 years]
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Change from Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
[Time Frame: Baseline up to 3 years]
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Change from Baseline in Crohn's Disease Activity Index (CDAI) Score
[Time Frame: Baseline up to 3 years]
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Change from Baseline in Harvey-Bradshaw Index (HBI) Score
[Time Frame: Baseline up to 3 years]
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Change from Baseline in C-reactive Protein (CRP) Concentration
[Time Frame: Baseline up to 3 years]
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Number of Participants with Adverse Events
[Time Frame: Approximately up to 3 years]
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Secondary ID(s)
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CR108610
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CNTO1275CRD4029
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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