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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.
NCT05609630 · View on ClinicalTrials.gov ↗
Study Summary
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to \< 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Conditions Studied
Interventions
- DRUG Upadacitinib
- DRUG Tocilizumab
Study Locations (20)
Other
- Hospital de Niños de la Santisima Trinidad /ID# 252736 — Córdoba
- Hospital Sao Paulo /ID# 251765 — São Paulo
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764 — São Paulo
Victoria
- Monash Health - Monash Medical Centre /ID# 251691 — Clayton
- Royal Children's Hospital /ID# 251663 — Parkville
Arizona
- Phoenix Children's Hospital /ID# 253403 — Phoenix
District of Columbia
- Childrens National Medical Center /ID# 253344 — Washington D.C.
New York
- New York Medical College /ID# 253437 — Valhalla
North Carolina
- Levine Children's Hospital /ID# 253491 — Charlotte
Ohio
- Cincinnati Childrens Hospital Medical Center /ID# 251827 — Cincinnati
Oregon
- Randall Children's Hospital /ID# 251829 — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2029-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05609630
The ClinicalTrials.gov registry entry for NCT05609630 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Juvenile Idiopathic Arthritis appearing as the primary indexed condition, and to 2 interventions — of which Upadacitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05609630 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Other, Victoria, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05609630 about?
NCT05609630 is a clinical study titled "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.". Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. ...
What is the current status of trial NCT05609630?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2023-10-02. Estimated completion is 2029-06.
What conditions does trial NCT05609630 study?
This clinical trial studies the following conditions: Juvenile Idiopathic Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05609630?
The interventions under investigation include: Upadacitinib (DRUG), Tocilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05609630?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05609630 being conducted?
This trial has 20 study locations across Arizona, District of Columbia, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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