About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ustekinumab
- Other Biologic Therapies