A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Cro… (NCT04372108) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
United States1,536 participantsStarted 2021-06-24
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically tracking the long-term rate of cancer in people using ustekinumab compared to other biologics, what does my doctor currently know about the cancer risk profile of ustekinumab versus the biologic they might recommend for me?
2This trial is observational and focused on safety monitoring rather than testing a new treatment — does that mean joining it wouldn't change which medication I actually receive, and how would my care be managed day to day?
3Given that malignancy incidence is the primary thing being measured here, do I have any personal risk factors — like a family history of cancer or a weakened immune system — that would make this kind of long-term safety data especially important for my treatment decision?
4How does this study compare the safety of ustekinumab to 'other biologics' — and which specific biologics are being used as the comparison group, so my doctor and I can understand whether the comparison is relevant to my situation?
5Would my doctor recommend I consider standard treatment options first, and if I end up on ustekinumab or another biologic anyway, is there a reason to participate in this observational study rather than just being monitored through regular care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.