Assessing the long-term safety of ustekinumab compared to other biologics for Crohn's disease and ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate and compare the long-term safety profiles of ustekinumab and other biologic therapies in adult patients diagnosed with Crohn's disease or ulcerative colitis. It focuses on measuring the incidence of overall malignancy, serious infections, and opportunistic infections among new users of these treatments. Participants must have a minimum of one year of enrollment history in the Department of Defense Electronic Health Record database prior to starting treatment. The study will provide valuable insights into the safety of these therapies over time.

Why it matters

Who can join: the full rules

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. Gaps in enrollment of ≤30 days will be considered continuous enrollment

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

Where it's running

• Bamc
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.