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New treatment option for Juvenile Idiopathic Arthritis
Official title 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 ID: NCT05609630
What this study is testing
What is Upadacitinib?
Upadacitinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for juvenile idiopathic arthritis.
Also referred to as RINVOQ, ABT-494.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin".
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- \- Baseline with a total body weight of 10 kg or higher at screening and symptoms of systemic juvenile idiopathic arthritis (sJIA) according to...
- Must have active sJIA with at least 2 active joints at Screening and Baseline, fever more than 38°C on at least one day within 14 consecutive days...
- Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or systemic glucocorticoids, as judged by the...
- For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or...
You likely can't join if
- Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any...
- Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Washington D.C., District of Columbia, United States
- Valhalla, New York, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Rosario, Santa Fe Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Córdoba, Argentina
- Clayton, Victoria, Australia
- Parkville, Victoria, Australia
- Bregenz, Vorarlberg, Austria
- Juiz de Fora, Minas Gerais, Brazil
- São Paulo, Brazil
- Chongqing, Chongqing Municipality, China
- Suzhou, Jiangsu, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Washington D.C., District of Columbia, United States; Valhalla, New York, United States; Charlotte, North Carolina, United States; Cincinnati, Ohio, United States; Portland, Oregon, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.