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Can a new pill ease arthritis in kids?

NCT ID NCT03725007

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is testing an oral medication called upadacitinib in children with polyarticular juvenile idiopathic arthritis (JIA), a condition causing joint inflammation. The goal is to understand how the drug moves through the body, its safety, and how well children tolerate it. Participants receive the drug in multiple parts, including a long-term extension to monitor ongoing safety and effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (an oral drug that modulates the immune system)
What this could lead to
If successful, this could provide a new treatment option to help control arthritis symptoms and improve quality of life for children with this condition.
What could go wrong
This is an early-phase study, so the drug may not work as hoped or could cause side effects. Results from this small group may not apply to all children with JIA.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant have total body weight of 10 kg or higher at the time of screening. * Participant diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA with active arthritis and without active systemic features) with a history of arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular JIA: \<=4 joints within first 6 months of disease and \>4 joints thereafter). * Participant have 5 or more active joints at the time of screening, defined as the presence of swollen joints (not due to deformity) or, in the absence of swelling, joints with the limitation of movement (LOM) plus pain on motion and/or tenderness with palpitation, with LOM present in at least three of the active joints. * 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 \<=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. * If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at least 1 week before and including Study Day 1. Exclusion Criteria: * Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA). * Participant have prior exposure to JAK inhibitor.

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Juvenile idiopathic arthritis (JIA)

Contacts and locations

Locations

  • Aichi Children's Health and Medical Center /ID# 248327

    Obu-shi, Aichi-ken, 474-8710, Japan

  • Alberta Children's Hospital /ID# 251738

    Calgary, Alberta, T3B 6A8, Canada

  • Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 211162

    Chicago, Illinois, 60611, United States

  • Asklepios Klinik Sankt Augustin /ID# 203264

    Sankt Augustin, North Rhine-Westphalia, 53757, Germany

  • Boston Children's Hospital /ID# 202993

    Boston, Massachusetts, 02115, United States

  • British Columbia Children and Women's Hospital and Health Centre /ID# 251736

    Vancouver, British Columbia, V6H 3N1, Canada

  • Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406

    Bayamón, 00959, Puerto Rico

  • Children's Hospital of Pittsburgh of UPMC /ID# 202994

    Pittsburgh, Pennsylvania, 15224-1334, United States

  • Cincinnati Childrens Hospital Medical Center /ID# 209697

    Cincinnati, Ohio, 45229, United States

  • Duplicate_McGill University Health Centre /ID# 251252

    Montreal, Quebec, H4A 3J1, Canada

  • Duplicate_University of Louisville /ID# 202896

    Louisville, Kentucky, 40202, United States

  • GCM Medical Group /ID# 211702

    San Juan, 00917-3104, Puerto Rico

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571

    Hamburg, 22081, Germany

  • Helios Klinikum Berlin-Buch /ID# 206859

    Berlin, 13125, Germany

  • Hospital Infantil Universitario Nino Jesus /ID# 206466

    Madrid, 28009, Spain

  • Hospital Sant Joan de Deu /ID# 203915

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario La Paz /ID# 203927

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal /ID# 203917

    Madrid, 28034, Spain

  • Hospital Universitario y Politecnico La Fe /ID# 203914

    Valencia, 46026, Spain

  • Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 246582

    Kobe, Hyōgo, 650-0045, Japan

  • Institute of Science Tokyo Hospital /ID# 246500

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Kagoshima University Hospital /ID# 246501

    Kagoshima, Kagoshima-ken, 890-8520, Japan

  • Mindful Medical Research /ID# 204488

    San Juan, 00918-3756, Puerto Rico

  • Miyagi Children's Hospital /ID# 246734

    Sendai, Miyagi, 989-3126, Japan

  • Niigata University Medical and Dental Hospital /ID# 247246

    Niigata, Niigata, 951-8520, Japan

  • Ospedale Pediatrico Bambino Gesù /ID# 203835

    Rome, Roma, 00165, Italy

  • PRI - Pediatric Rheumatology Research Institute /ID# 205954

    Bad Bramstedt, Schleswig-Holstein, 24576, Germany

  • Queen Silvia Children's Hosp /ID# 251145

    Gothenburg, Västra Götaland County, 416 85, Sweden

  • Randall Children's Hospital /ID# 213609

    Portland, Oregon, 97227-1654, United States

  • Seattle Children's Hospital /ID# 203003

    Seattle, Washington, 98105, United States

  • Semmelweis Egyetem /ID# 208970

    Budapest, 1085, Hungary

  • St Marianna University School Of Medicine /ID# 246478

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • St. Josef-Stift Sendenhorst /ID# 244740

    Sendenhorst, North Rhine-Westphalia, 48324, Germany

  • The Chaim Sheba Medical Center /ID# 222370

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Children's Hospital of Philadelphia /ID# 209617

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.