RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Ustekinumab for Crohn Disease

This study wants 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).

Official registry: https://clinicaltrials.gov/study/NCT04372108 · Janssen Scientific Affairs, LLC · enrollment listed as 1,536

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 1,536 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database

Interventions: Ustekinumab, Other Biologic Therapies

Primary outcome (registry wording): Incidence Rate for Malignancy

Who it is for (from inclusion criteria)

Ages 18 Years to any
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. Gaps in enrollment of ≤30 days will be considered continuous enrollment

Who the registry excludes

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

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

BAMC — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT04372108 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04372108?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04372108?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary