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NCT04372108 · ClinicalTrials.gov registry record
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
A clinical trial of Crohn Disease and Colitis, Ulcerative, sponsored by Janssen Scientific Affairs.
- Recruiting
- Registry status
- 1,056
- Enrollment target
- 1
- Study location
NCT04372108: Recruiting study of Crohn Disease and Colitis, Ulcerative, sponsored by Janssen Scientific Affairs.
NCT04372108 is a study of Crohn Disease and Colitis, Ulcerative that is actively recruiting participants, run by Janssen Scientific Affairs. The registered enrollment target is 1,056 participants, above the 191-participant average among 71 other Crohn Disease trials with a reported enrollment target (453% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04372108, a study of Crohn Disease and Colitis, Ulcerative, is actively recruiting participants, sponsored by Janssen Scientific Affairs.
- RECRUITING
- Registry status
- 1,056 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
The incidence rates for malignancy (including Non-melanoma skin cancer \[NMSC\]) will be estimated as the number of incident cases (that is, counts of unique participants) divided by the total at-risk time.
Conditions Studied
Interventions
- DRUG Ustekinumab
- DRUG Other Biologic Therapies
Study Locations (1)
Virginia
- NMCP - Portsmouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,056 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2030-08-30 |
What NCT04372108 shows while recruiting
NCT04372108 is an observational study that tracks outcomes without assigning an intervention. Its 1,056 participants enrollment target places it among the larger protocols in the corpus, above the 191-participant average among 71 other Crohn Disease trials with a reported enrollment target (453% higher).
The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Ustekinumab is the first listed.
NCT04372108 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04372108 about?
NCT04372108 is a clinical study titled "A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis". 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).
What is the current status of trial NCT04372108?
This trial is currently recruiting. The enrollment target is 1,056 participants. The study started on 2021-06-24. Estimated completion is 2030-08-30.
What conditions does trial NCT04372108 study?
This clinical trial studies the following conditions: Crohn Disease, Colitis, Ulcerative.
What interventions are being tested in trial NCT04372108?
The interventions under investigation include: Ustekinumab (DRUG), Other Biologic Therapies (DRUG).
Who is sponsoring clinical trial NCT04372108?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04372108 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04372108's enrollment target sits among peer trials
1,056 4th of 71 higher than 68 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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