Assessing the long-term safety of ustekinumab compared to other biologics for Crohn's disease and ulcerative colitis
An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
This study is testing how safe the drug ustekinumab is compared to other biologic treatments for adults with Crohn's disease or ulcerative colitis over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1056 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Scientific Affairs, LLC Industry-sponsored |
| Drugs / interventions | ustekinumab |
| Locations | 1 site (Portsmouth, Virginia) |
| Trial ID | NCT04372108 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult men and women who are new users of ustekinumab or other biologic therapies for Crohn's disease or ulcerative colitis.
Not a fit: Patients under 18 years of age or those with certain comorbidities such as HIV or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify safer treatment options for patients with Crohn's disease and ulcerative colitis.
How similar studies have performed: Other studies have shown varying results regarding the safety of biologic therapies, making this investigation relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portsmouth, Virginia
- Nmcp — Portsmouth, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.