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.

NCT ID
NCT05609630
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 3
Sponsor
AbbVie

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 90 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: \- Baseline with a total body weight of 10 kg or higher at screening and symptoms of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions: * 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 before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) \> upper limit of normal (ULN) at Screening. OR At least 4 active joints at Screening and Baseline and an ESR or hsCRP \> ULN at Screening. * Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or systemic glucocorticoids, as judged by the investigator. * For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator. Note: For Cohort 1, participants must be ages 2 to \< 18 years old in countries where SC tocilizumab is not approved for sJIA. Exclusion Criteria: * 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 other autoimmune inflammatory condition other than sJIA. * Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.

Study locations

45 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Argentina, Australia, Austria, Brazil, China, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States

  • Santa Fe Province, Argentina: 1
  • Tucumán Province, Argentina: 1
  • Victoria, Australia: 2
  • Vorarlberg, Austria: 1
  • Minas Gerais, Brazil: 1
  • Chongqing Municipality, China: 1
  • Jiangsu, China: 1
  • Shaanxi, China: 1
  • Shanghai Municipality, China: 1
  • Zhejiang, China: 1
  • Baden-Wurttemberg, Germany: 1
  • North Rhine-Westphalia, Germany: 2
  • Firenze, Italy: 1
  • Genova, Italy: 1
  • Hyōgo, Japan: 1
  • Kanagawa, Japan: 1
  • Niigata, Japan: 1
  • Osaka, Japan: 1
  • Tokyo, Japan: 1
  • Jalisco, Mexico: 1
  • Barcelona, Spain: 1
  • Västra Götaland County, Sweden: 1
  • Greater London, United Kingdom: 1
  • Arizona, United States: 1
  • District of Columbia, United States: 1
  • New York, United States: 1
  • North Carolina, United States: 1
  • Ohio, United States: 1
  • Oregon, United States: 1

Sample of listed locations

  • Instituto CAICI S.R.L /ID# 251448 — Rosario, Santa Fe Province, 2000, Argentina — Site recruitment status not specified in the registry data
  • Centro de Investigaciones Medicas Tucuman /ID# 251781 — San Miguel de Tucumán, Tucumán Province, 4000, Argentina — Site recruitment status not specified in the registry data
  • Hospital de Niños de la Santisima Trinidad /ID# 252736 — Córdoba, 5014, Argentina — Site recruitment status not specified in the registry data
  • Monash Health - Monash Medical Centre - Clayton /ID# 251691 — Clayton, Victoria, 3168, Australia — Site recruitment status not specified in the registry data
  • Royal Children's Hospital /ID# 251663 — Parkville, Victoria, 3052, Australia — Site recruitment status not specified in the registry data
  • Landeskrankenhaus Bregenz /ID# 266317 — Bregenz, Vorarlberg, 6900, Austria — Site recruitment status not specified in the registry data
  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769 — Juiz de Fora, Minas Gerais, 36010-570, Brazil — Site recruitment status not specified in the registry data
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764 — São Paulo, 05403-000, Brazil — Site recruitment status not specified in the registry data
  • Hospital Sao Paulo /ID# 251765 — São Paulo, 04023-062, Brazil — Site recruitment status not specified in the registry data
  • The Childrens Hospital of Chongqing Medical University /ID# 251539 — Chongqing, Chongqing Municipality, 400065, China — Site recruitment status not specified in the registry data
  • Children'S Hospital Of Soochow University /ID# 251755 — Suzhou, Jiangsu, 215025, China — Site recruitment status not specified in the registry data
  • Xi'an Children's Hospital /ID# 251693 — Xi'an, Shaanxi, 710054, China — Site recruitment status not specified in the registry data
  • Children's Hospital of Fudan University /ID# 251619 — Shanghai, Shanghai Municipality, 200032, China — Site recruitment status not specified in the registry data
  • The Children's Hospital of Zhejiang University School of Medicine /ID# 251754 — Hangzhou, Zhejiang, 310003, China — Site recruitment status not specified in the registry data
  • Universitaetsklinikum Freiburg /ID# 253288 — Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany — Site recruitment status not specified in the registry data
  • Asklepios Klinik Sankt Augustin /ID# 251565 — Sankt Augustin, North Rhine-Westphalia, 53757, Germany — Site recruitment status not specified in the registry data
  • St. Josef-Stift Sendenhorst /ID# 268680 — Sendenhorst, North Rhine-Westphalia, 48324, Germany — Site recruitment status not specified in the registry data
  • Helios Klinikum Berlin - Buch /ID# 279847 — Berlin, 13125, Germany — Site recruitment status not specified in the registry data
  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564 — Hamburg, 22081, Germany — Site recruitment status not specified in the registry data
  • Semmelweis Egyetem /ID# 266750 — Budapest, 1085, Hungary — Site recruitment status not specified in the registry data
  • Azienda Ospedaliero Universitaria Meyer /ID# 251775 — Florence, Firenze, 50139, Italy — Site recruitment status not specified in the registry data
  • IRCCS Istituto Giannina Gaslini /ID# 251776 — Genoa, Genova, 16147, Italy — Site recruitment status not specified in the registry data
  • Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649 — Kobe, Hyōgo, 650-0045, Japan — Site recruitment status not specified in the registry data
  • St Marianna University School Of Medicine /ID# 251623 — Kawasaki-shi, Kanagawa, 216-8511, Japan — Site recruitment status not specified in the registry data
  • Niigata University Medical and Dental Hospital /ID# 251538 — Niigata, Niigata, 951-8520, Japan — Site recruitment status not specified in the registry data

Study details

Start date
October 2, 2023
Primary completion date
June 1, 2029
First posted
November 8, 2022

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05609630
Registry last updated
September 15, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT05609630 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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