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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
Pivotal Trial
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years and 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years and 4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSide effects data
From 2018 Phase 4 trial • 43 Patients • NCT0218717250%
Upper respiratory infection
27%
Common cold
9%
Skin and subcutaneous tissue disorders
9%
Fracture
9%
Anxiety
9%
Dizziness
9%
Back pain
9%
Urinary tract infection
5%
Toothache
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2015
Completed Phase 4
~4080
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,403,296 Total Patients Enrolled
24 Trials studying Psoriasis
8,329 Patients Enrolled for Psoriasis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,978,897 Total Patients Enrolled
20 Trials studying Psoriasis
6,524 Patients Enrolled for Psoriasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition improved with ustekinumab as shown in my last study visit.I am capable of becoming pregnant and have a negative pregnancy test.I have or was in close contact with someone who has COVID-19.I have finished all my ustekinumab treatments as planned in a previous study.I am a minor and have signed the assent form, and will sign the adult consent form later.I may have received a live vaccine but can stay in the study if the sponsor agrees and I pause the study treatment for a time they specify.
Research Study Groups:
This trial has the following groups:- Group 1: Ustekinumab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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