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Interleukin-6 (IL-6) Receptor Antagonist

Upadacitinib + Tocilizumab for Juvenile Idiopathic Arthritis (SELECT-sJIA Trial)

Q: Is this study open to individuals who are over twenty years of age?

For this medical trial, only those aged 1-17 are eligible to participate. 58 studies have been conducted for minors while337 trials targeted participants over 65 years old.

Q: Has the FDA given a seal of approval to Upadacitinib in Cohort 1?

Cohort 1 Upadacitinib has prior clinical data that indicate its safety, thus earning it a score of 3.

Q: Are there unfilled vacancies in the clinical trial that can be filled by participants?

Affirmative. According to the information located on clinicaltrials.gov, this study is currently in search of participants with its initial post date being July 11th2023 and most recent update taking place on July 3rd 2023. 90 individuals are expected to be enrolled at one medical site.

Q: Who meets the criteria for participation in this trial?

This clinical trial is recruiting up to 90 juvenile idiopathic <a href="https://www.withpower.com/clinical-trials/arthritis">arthritis</a> patients between the ages of 1 and 17. To be eligible, applicants must exhibit an active <a href="https://www.withpower.com/clinical-trials/sjia">sjia</a> with 2 or more joints at screening as well as a fever above 38°C on any out of 14 consecutive days before their appointment; in addition, they will need to have an ESR or hsCRP >1.5 × ULN at Screening. Moreover, these individuals should have had an inadequate response to nonsteroidal anti-inflammatory drugs and systemic glucocorticoids while those recruited for Cohort 1 must not have previously used IL-

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

SELECT-sJIA Trial Summary

This trial is evaluating a potential new treatment for juvenile idiopathic arthritis, a chronic disease that affects children and can continue into adulthood. Participants will receive either upadacitinib or tocilizumab and be assessed for adverse events and disease activity.

Who is the study for?

This trial is for children and adolescents aged 1 to <18 with systemic juvenile idiopathic arthritis (sJIA). They must have at least 2 active joints, fever over 38°C, or elevated inflammation markers. Participants in Cohort 1 can't have had IL-6 inhibitor treatment; those in Cohort 2 must not respond well to it.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Upadacitinib, an oral medication, against Tocilizumab, given as a subcutaneous injection or intravenous infusion. About 90 participants will be randomly assigned to receive one of these treatments for a year.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site for Tocilizumab and gastrointestinal issues, infections, or liver problems with Upadacitinib. Regular medical assessments will monitor any adverse events throughout the trial.

SELECT-sJIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response

Secondary outcome measures

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Change From Baseline in Patient's Global Assessment (PtGA)

Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)

+13 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

SELECT-sJIA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2 UpadacitinibExperimental Treatment1 Intervention

Participants will receive upadacitinib for 52 weeks.

Group II: Cohort 1 UpadacitinibExperimental Treatment1 Intervention

Participants will receive upadacitinib for 52 weeks.

Group III: Cohort 1 TocilizumabActive Control1 Intervention

Participants will receive tocilizumab for 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,300 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,019 Total Patients Enrolled

Media Library

Tocilizumab (Interleukin-6 (IL-6) Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05609630 — Phase 3

Frequently Asked Questions

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

Is this study open to individuals who are over twenty years of age?

"For this medical trial, only those aged 1-17 are eligible to participate. 58 studies have been conducted for minors while337 trials targeted participants over 65 years old."

Answered by AI

Has the FDA given a seal of approval to Upadacitinib in Cohort 1?

"Cohort 1 Upadacitinib has prior clinical data that indicate its safety, thus earning it a score of 3."

Answered by AI

Are there unfilled vacancies in the clinical trial that can be filled by participants?

"Affirmative. According to the information located on clinicaltrials.gov, this study is currently in search of participants with its initial post date being July 11th2023 and most recent update taking place on July 3rd 2023. 90 individuals are expected to be enrolled at one medical site."

Answered by AI

Who meets the criteria for participation in this trial?

"This clinical trial is recruiting up to 90 juvenile idiopathic arthritis patients between the ages of 1 and 17. To be eligible, applicants must exhibit an active sjia with 2 or more joints at screening as well as a fever above 38°C on any out of 14 consecutive days before their appointment; in addition, they will need to have an ESR or hsCRP >1.5 × ULN at Screening. Moreover, these individuals should have had an inadequate response to nonsteroidal anti-inflammatory drugs and systemic glucocorticoids while those recruited for Cohort 1 must not have previously used IL-"

Answered by AI

How many people are presently enrolled in this experiment?

"Affirmative, clinicaltrials.gov confirms that the trial is actively enrolling participants with an initial posting date of 11 July 2023 and a recent update on 3 July 2023. A total of 90 patients are needed at one medical centre for this study to be successful."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.

2023. "Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05609630.

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