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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the long-term safety of ustekinumab with other biologic medicines in adults starting these treatments. It is for people with Crohn's disease or ulcerative colitis, which cause swelling in the digestive tract. The study looks at cancer, serious infections, and infections that occur more easily when the body's defenses are weak.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with Crohn's disease or ulcerative colitis who starts ustekinumab or one of the other study medicines during the study.
  • You have at least 1 year of records in the Department of Defense (DoD) electronic health record database right before starting the medicine.

Who can't join

  • You are younger than 18 when you start the medicine.
  • You do not meet the study's definition of Crohn's disease or ulcerative colitis by the day you start the medicine.
  • You have any record of HIV, a virus that weakens the body's defenses, by the day you start the medicine.
  • You have had an organ or tissue transplant by the day you start the medicine.
  • You have any record of cancer by the day you start the medicine, except non-melanoma skin cancer.
  • A doctor diagnosed you with rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis in the 12 months before or on the day you start the medicine. These diseases cause swelling in the joints or spine.
  • For infection results only: you have the same infection being studied both within 60 days before or on the day you start the medicine and within 60 days afterward.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX