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Monoclonal Antibodies

Long-Term Ustekinumab for Pediatric Crohn's Disease (UNITED Trial)

Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration
Must have completed the dosing planned in the primary pediatric ustekinumab study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years and 4 months
Awards & highlights

UNITED Trial Summary

This trial will help researchers understand the long-term effects of ustekinumab, a medication used to treat autoimmune diseases.

Who is the study for?
This trial is for pediatric patients who have completed a primary ustekinumab study for Crohn's Disease, Psoriatic Arthritis, or Ulcerative Colitis. They must show benefits from previous treatment and agree to lifestyle restrictions. Girls must not be pregnant and all participants should not plan on becoming parents soon.Check my eligibility
What is being tested?
The trial is testing the long-term safety of ustekinumab, an injectable medication given under the skin (subcutaneous), in children who have shown improvement with this drug during a prior study.See study design
What are the potential side effects?
While specific side effects are not listed here, long-term safety data collection suggests monitoring for any adverse reactions due to prolonged use of ustekinumab in young patients.

UNITED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am capable of becoming pregnant and have a negative pregnancy test.
Select...
I have finished all my ustekinumab treatments as planned in a previous study.

UNITED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years and 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With AEs of Worsening of the Disease
Number of Participants With Adverse Events (AEs)
Number of Participants With Concomitant Therapy due to Loss of Response
+5 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

UNITED Trial Design

1Treatment groups
Experimental Treatment
Group I: UstekinumabExperimental Treatment1 Intervention
Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
2013
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,157 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,754 Total Patients Enrolled

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05092269 — Phase 3
Crohn's Disease Research Study Groups: Ustekinumab
Crohn's Disease Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT05092269 — Phase 3
Ustekinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05092269 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If an individual is below 75 years old, do they qualify for this research project?

"As per the inclusion criteria for this research, children aged 2-17 are eligible to participate."

Answered by AI

To what afflictions is Ustekinumab commonly prescribed?

"Ustekinumab can help patients experiencing adrenal cortex hormone deficiency, an inadequate response to TNF antagonist therapies, and psoriasis."

Answered by AI

Could you please list any other scientific papers that have been published on Ustekinumab?

"Ustekinumab was first studied in the year 2014 at Attikon Hospital. Since then there are 75 completed trials. There are presently 35 live studies, with many of these studies being performed out of New york, New York."

Answered by AI

Are people needed for this experiment right now?

"The clinicaltrials.gov website shows that this trial is still looking for patients. The listing was first created on October 18th, 2021 and the most recent update was on November 9th, 2022."

Answered by AI

For whom is this research project seeking participants?

"Potential participants of this clinical trial must have arthritis, psoriatic, and be aged 2-17. The research team is looking to recruit a total of around 151 patients."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Mount Sinai
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have been trying to self-treat myself for psoriasis after having a bad experience with the doctor that originally diagnosed me.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Are the days for screening visits flexible and how long are the visits?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Long-term Extension Study of Ustekinumab in Pediatric Participants
2021. "A Long-term Extension Study of Ustekinumab in Pediatric Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092269.
All > Crohns Disease > Psoriatic Arthritis
~87 spots leftby Sep 2027
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