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Janus Kinase (JAK) Inhibitor

Upadacitinib for Juvenile Arthritis (SELECT-YOUTH Trial)

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant have total body weight of 10 kg or higher at the time of screening.
If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on a stable dose of 10 to 20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 156 weeks
Awards & highlights

SELECT-YOUTH Trial Summary

This trial will assess the effects of a new drug on children with juvenile idiopathic arthritis. The study will be conducted in three parts, with the option for participants to enroll in the second and third parts if they do not experience any adverse effects from the study drug.

Who is the study for?
This trial is for children with polyarticular course juvenile idiopathic arthritis (pcJIA) who have at least 5 active joints and weigh over 10 kg. They must have been diagnosed with pcJIA, possibly taking methotrexate for 12 weeks or more, and if on steroids, they should be on a stable dose. Kids with enthesitis-related arthritis or juvenile psoriatic arthritis, or those previously treated with JAK inhibitors can't participate.Check my eligibility
What is being tested?
The study tests Upadacitinib's effects in kids with pcJIA across three parts: initial multiple-dose groups, an open-label extension to assess long-term safety/tolerability, and an additional cohort for further safety evaluation. The goal is to understand how the drug works in young bodies and monitor its ongoing safety.See study design
What are the potential side effects?
While specific side effects are not listed here, typically such trials look out for any adverse reactions related to the medication being tested which could include gastrointestinal issues, skin reactions, changes in blood counts or liver enzymes among others.

SELECT-YOUTH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 10 kg.
Select...
I have been on a stable dose of methotrexate for at least 8 weeks and take folic or folinic acid.
Select...
I have been on a stable dose of oral glucocorticosteroids for at least a week.
Select...
I have been diagnosed with a type of juvenile arthritis affecting 5 or more joints within the first 6 months.
Select...
I have 5 or more joints with swelling, pain, or limited movement.

SELECT-YOUTH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 156 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 156 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Apparent oral clearance at steady state (CL/F)
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)
Part 1: Half-life
+3 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

SELECT-YOUTH Trial Design

5Treatment groups
Experimental Treatment
Group I: Participants of age group 6 to <12 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 6 to <12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Group II: Participants of age group 2 to <6 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 2 to <6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Group III: Participants of age group 2 to <18 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 2 to <18 years administered with upadacitinib dose A as described in the protocol.
Group IV: Participants of age group 12 to <18 years receiving dose BExperimental Treatment1 Intervention
Participants of age group 12 to <18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.
Group V: Participants of age group 12 to <18 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 12 to <18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
949 Previous Clinical Trials
496,694 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
389 Previous Clinical Trials
141,485 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03725007 — Phase 1
Juvenile Idiopathic Arthritis Research Study Groups: Participants of age group 12 to <18 years receiving dose A, Participants of age group 12 to <18 years receiving dose B, Participants of age group 6 to <12 years receiving dose A, Participants of age group 2 to <6 years receiving dose A, Participants of age group 2 to <18 years receiving dose A
Juvenile Idiopathic Arthritis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03725007 — Phase 1
Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03725007 — Phase 1

Frequently Asked Questions

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

Are there any specific demographics that would be more suited to participate in this trial?

"This clinical trial is seeking 124 patients aged between 2 and 17 suffering from juvenile arthritis. In order to be accepted, candidates must have been taking methotrexate for a minimum of 12 weeks prior to the start date at a stable dose of 10-20 mg/m2; they should also take either folic acid or folinic acid according to local protocol. Furthermore, participants need to possess total body weight greater than 10 kg upon screening and fulfill criteria such as being diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA"

Answered by AI

What clinical applications has Upadacitinib seen success in?

"Upadacitinib is mostly used as a systemic therapy for individuals afflicted with rheumatoid arthritis, methotrexate, and any other condition that has not responded to conventional treatments."

Answered by AI

To what degree has Upadacitinib been tested in clinical trials previously?

"Upadacitinib was initially studied in 2015 by AZ Arthritis and Rheum Assoc (ID# 143130). Thus far, there have been 21 successful trials with an additional 21 presently underway around the Cincinnati region."

Answered by AI

What is the maximum number of individuals who will be enrolled in this trial?

"This trial requires 124 participants who meet its eligibility criteria. These patients can be recruited from 2 different medical centres; Cincinnati Childrens Hosp Med/ID# 209697 situated in Cincinnati, Ohio and a second branch at the Cincinnati Childrens Hospital Medical Center / ID#209697 based in Philadelphia, Pennsylvania."

Answered by AI

Does the protocol for this trial include participants aged thirty and above?

"The inclusion criteria for this experiment necessitates that participants are between the ages of two and seventeen. Subsequently, there are 62 total studies aimed at minors and 333 specifically targeting those over 65 years of age."

Answered by AI

Are any North American healthcare facilities conducting this trial?

"This clinical trial is occurring at 11 different sites, the most prominent of which are the Cincinnati Childrens Hosp Med in Ohio, the Cincinnati Children's Hospital Medical Center in Pennsylvania and the Children's Hospital of Philadelphia in Washington."

Answered by AI

Is the opportunity for participation in this trial available to individuals currently?

"According to clinicaltrials.gov, this medical trial has been ongoing since June 24th 2019 and is still currently recruiting patients. The most recent update was on October 17th 2022."

Answered by AI

Is this research unprecedented in its scope?

"Since 2015, research into Upadacitinib has been conducted. Originally sponsored by AbbVie in 2015 with 1629 patients, the drug was granted Phase 3 approval following this study. Nowadays there are 21 clinical trials for Upadacitinib across 54 countries and 953 cities."

Answered by AI

Has Upadacitinib been sanctioned by the FDA?

"Data collected thus far on Upadacitinib's safety and efficacy suggest that it should receive a score of 1."

Answered by AI
~51 spots leftby Aug 2027