NCT04372108 A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
| NCT ID | NCT04372108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen Scientific Affairs, LLC |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,056 participants |
| Start Date | 2021-06-24 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,056 participants in total. It began in 2021-06-24 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).
Eligibility Criteria
Inclusion Criteria: * Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period * Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs Exclusion Criteria: * Participants below 18 years of age on the exposure index date * Participants who do not meet the definition for CD or UC prior to or on the exposure index date * Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \[NMSC\]) at any time prior to or on the exposure index date * Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date * In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded
Contact & Investigator
Janssen Scientific Affairs, LLC Clinical Trial
STUDY DIRECTOR
Janssen Scientific Affairs, LLC
Frequently Asked Questions
Who can join the NCT04372108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04372108 currently recruiting?
Yes, NCT04372108 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT04372108 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04372108 clinical trial?
NCT04372108 is sponsored by Janssen Scientific Affairs, LLC. The principal investigator is Janssen Scientific Affairs, LLC Clinical Trial at Janssen Scientific Affairs, LLC. The trial plans to enroll 1,056 participants.