A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

Launched by JANSSEN SCIENTIFIC AFFAIRS, LLC · Apr 30, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term safety of a medication called ustekinumab compared to other similar treatments for adults with Crohn's disease or ulcerative colitis. The main goal is to see how often patients develop serious health issues, like certain types of cancer or serious infections, when starting these medications. Researchers want to understand if there are differences in these risks between people using ustekinumab and those using other biologic therapies.

To participate in this study, you need to be an adult man or woman who is starting treatment with either ustekinumab or another biologic drug for the first time. You should also have at least one year of medical history in the Department of Defense's health records before starting the medication. However, people under 18, those with certain serious health conditions like HIV or a history of cancer, or those diagnosed with specific autoimmune diseases recently will not be eligible. If you join the study, you can expect to provide some health information and be monitored over time to track any side effects or health issues that may arise from the treatments.

Gender

ALL

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