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 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M14-6822022-501599-25-00
• Study Type: interventional
• Target: 90
• Locations: 16 countries
• Sites: 42

Brief 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

Juvenile Idiopathic Arthritis

Keywords

Systemic Juvenile Idiopathic Arthritis; sJIA; Upadacitinib; ABT-494

Outcome Measures

Primary Outcomes (2)

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

  ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 30 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 30% of the 6 variables of the JIA core set with no more than 1 variable worsening by \> 30%.

  At Week 12

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Approximately Week 52

Secondary Outcomes (16)

• Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response

  Week 12

• Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response

  Week 12

• Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response

  Week 12

• Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response

  Week 12

• Change from Baseline in Number of Joints with Active Arthritis

  Week 12

Study Arms (3)

Cohort 1 Upadacitinib

EXPERIMENTAL

Participants will receive upadacitinib for 52 weeks.

Drug: Upadacitinib

Cohort 1 Tocilizumab

ACTIVE COMPARATOR

Participants will receive tocilizumab for 52 weeks.

Drug: Tocilizumab

Cohort 2 Upadacitinib

EXPERIMENTAL

Participants will receive upadacitinib for 52 weeks.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Oral tablet or Oral solution

Also known as: RINVOQ, ABT-494

Cohort 1 Upadacitinib; Cohort 2 Upadacitinib

Tocilizumab DRUG

Subcutaneous injection or Intravenous infusion

Cohort 1 Tocilizumab

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify 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 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (44)

Phoenix Children's Hospital /ID# 253403

Phoenix, Arizona, 85016-7710, United States

RECRUITING

Childrens National Medical Center /ID# 253344

Washington D.C., District of Columbia, 20010-2916, United States

RECRUITING

New York Medical College /ID# 253437

Valhalla, New York, 10595, United States

RECRUITING

Levine Children's Hospital /ID# 253491

Charlotte, North Carolina, 28203, United States

RECRUITING

Cincinnati Childrens Hospital Medical Center /ID# 251827

Cincinnati, Ohio, 45229, United States

RECRUITING

Randall Children's Hospital /ID# 251829

Portland, Oregon, 97227-1654, United States

RECRUITING

Instituto CAICI S.R.L /ID# 251448

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Centro de Investigaciones Medicas Tucuman /ID# 251781

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Hospital de Niños de la Santisima Trinidad /ID# 252736

Córdoba, 5014, Argentina

RECRUITING

Monash Health - Monash Medical Centre /ID# 251691

Clayton, Victoria, 3168, Australia

COMPLETED

Royal Children's Hospital /ID# 251663

Parkville, Victoria, 3052, Australia

COMPLETED

Landeskrankenhaus Bregenz /ID# 266317

Bregenz, Vorarlberg, 6900, Austria

RECRUITING

CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769

Juiz de Fora, Minas Gerais, 36010-570, Brazil

COMPLETED

Hospital Sao Paulo /ID# 251765

São Paulo, 04023-062, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764

São Paulo, 05403-000, Brazil

RECRUITING

The Childrens Hospital of Chongqing Medical University /ID# 251539

Chongqing, Chongqing Municipality, 400065, China

RECRUITING

Children'S Hospital Of Soochow University /ID# 251755

Suzhou, Jiangsu, 215025, China

RECRUITING

Xi'an Children's Hospital /ID# 251693

Xi'an, Shaanxi, 710054, China

RECRUITING

Children's Hospital of Fudan University /ID# 251619

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The Children's Hospital of Zhejiang University School of Medicine /ID# 251754

Hangzhou, Zhejiang, 310003, China

RECRUITING

Universitaetsklinikum Freiburg /ID# 253288

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Asklepios Klinik Sankt Augustin /ID# 251565

Sankt Augustin, North Rhine-Westphalia, 53757, Germany

RECRUITING

St. Josef-Stift Sendenhorst /ID# 268680

Sendenhorst, North Rhine-Westphalia, 48324, Germany

RECRUITING

Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564

Hamburg, 22081, Germany

RECRUITING

Semmelweis Egyetem /ID# 266750

Budapest, 1085, Hungary

RECRUITING

Azienda Ospedaliero Universitaria Meyer /ID# 251775

Florence, Firenze, 50139, Italy

RECRUITING

IRCCS Istituto Giannina Gaslini /ID# 251776

Genoa, Genova, 16147, Italy

RECRUITING

Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649

Kobe, Hyōgo, 650-0045, Japan

RECRUITING

St Marianna University School Of Medicine /ID# 251623

Kawasaki-shi, Kanagawa, 216-8511, Japan

RECRUITING

Niigata University Medical & Dental Hospital /ID# 251538

Niigata, Niigata, 951-8520, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital /ID# 252092

Takatsuki-shi, Osaka, 569-8686, Japan

RECRUITING

Institute of Science Tokyo Hospital /ID# 251505

Bunkyo-ku, Tokyo, 113-8519, Japan

RECRUITING

CREA de Guadalajara SC /ID# 252917

Guadalajara, Jalisco, 44620, Mexico

RECRUITING

Universitair Medisch Centrum Utrecht /ID# 267435

Utrecht, 3584 CX, Netherlands

RECRUITING

Hospital Sant Joan de Deu /ID# 251353

Esplugues de Llobregat, Barcelona, 08950, Spain

RECRUITING

Hospital Universitario y Politecnico La Fe /ID# 251352

Valencia, 46026, Spain

RECRUITING

Queen Silvia Children's Hosp /ID# 251318

Gothenburg, Västra Götaland County, 416 85, Sweden

RECRUITING

National Taiwan University Hospital /ID# 267387

Taipei, 100, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 267390

Taoyuan, 333, Taiwan

RECRUITING

Gazi University Medical Faculty /ID# 253677

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Istanbul University Istanbul Medical Faculty /ID# 251652

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Umraniye Training and Res Hosp /ID# 251653

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Great Ormond Street Children's Hospital /ID# 251512

London, Greater London, WC1N 3HZ, United Kingdom

RECRUITING

Related Links

• Related info

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

upadacitinib; tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 8, 2022
• Study Start: October 2, 2023
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

TW (2); ES (2); TU (4); JP (5); AU (1); BR (3); IT (2); SE (1); AR (3); CN (5); HU (1); DE (4); ME (1); NL (1); GB (1); US (6)