A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ustekinumab, Other Biologic Therapies.
- Who it may be relevant to
- Registry conditions: Crohn Disease, Colitis, Ulcerative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RRA-18896: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
Overview
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).
Interventions
- Drug Ustekinumab
Participants who are new users of ustekunumab will be included in the cohort. No study treatment will be administered as a part of this study. - Drug Other Biologic Therapies
Participants who are new users of other biologic therapies (for examples for example, infliximab, adalimumab, or vedolizumab administered as per the prescription record) will be included in this cohort. No study treatment will be administered as a part of this study.
Primary outcome measures
- Incidence Rate for Malignancy [Time frame: Up to 10 years and 3 months]
Secondary outcome measures (2)
- Opportunistic Infection (OI) [Time frame: Up to 10 years and 3 months]
- Serious Infection [Time frame: Up to 10 years and 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- BAMC — Houston
Identifiers
NCT: NCT04372108 · CR108561 · RRA-18896