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.

Phase 3RecruitingNCT05609630

AbbVie90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

UpadacitinibDRUG

Oral tablet or Oral solution

TocilizumabDRUG

Subcutaneous injection or Intravenous infusion

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (44)

Phoenix Children's Hospital /ID# 253403

Phoenix, Arizona, United States

RECRUITING

Childrens National Medical Center /ID# 253344

Washington D.C., District of Columbia, United States

RECRUITING

New York Medical College /ID# 253437

Valhalla, New York, United States

RECRUITING

Levine Children's Hospital /ID# 253491

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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%.

Time frame: 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.

Time frame: Up to Approximately Week 52

Secondary Outcomes

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 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 50 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 50% of the 6 variables of the JIA core set.

Time frame: Week 12

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 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 70 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 70% of the 6 variables of the JIA core set.

Time frame: Week 12

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 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 90 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 90% of the 6 variables of the JIA core set.

Time frame: Week 12

Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 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 100 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 100% of the 6 variables of the JIA core set.

Time frame: Week 12

Change from Baseline in Number of Joints with Active Arthritis

Time frame: Week 12

Change from Baseline in Number of Joints with Limitation of Motion

Time frame: Week 12

Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)

The CHAQ-DI consists of 30 items and assesses function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 5 response options ranging from no difficulty to unable to do, scored 0 to 3, and not applicable.

Time frame: Week 12

Change From Baseline in Patient's Global Assessment (PtGA)

Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.

Time frame: Week 12

Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)

Time frame: Week 12

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from baseline in CRP is assessed at each time point.

Time frame: Week 12

Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)

Absence of fever (\> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)

Time frame: Week 12

Change from Baseline in Glucocorticoid Dose

Time frame: Week 12

Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)

Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed

Time frame: Week 12

Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP

Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.

Time frame: Week 12

Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP

Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.

Time frame: Week 12

Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP

Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed.

Time frame: Week 12

Central Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cincinnati Childrens Hospital Medical Center /ID# 251827

Cincinnati, Ohio, United States

RECRUITING

Randall Children's Hospital /ID# 251829

Portland, Oregon, United States

RECRUITING

Instituto CAICI S.R.L /ID# 251448

Rosario, Santa Fe Province, Argentina

RECRUITING

Centro de Investigaciones Medicas Tucuman /ID# 251781

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Hospital de Niños de la Santisima Trinidad /ID# 252736

Córdoba, Argentina

RECRUITING

Monash Health - Monash Medical Centre /ID# 251691

Clayton, Victoria, Australia

COMPLETED

...and 34 more locations

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.

Overview

Conditions

Interventions

Eligibility

Locations (44)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts