![Guidelines + Trials Rundown - Juvenile Arthritis](https://www.guidelinecentral.com/wp-content/uploads/2024/05/Guidelines-Trials-Rundown-Gout-1.jpg)
We’re going to take a look at the ongoing studies and clinical trials specific to juvenile arthritis.
The below list was curated by assessing the ongoing Phase 3 trials for juvenile arthritis that are based in the United States. The dates provided are estimates, and subject to change. The list is primarily studies that have posted updates within 12 months or less.
This series is intended to provide a preview of what new innovations are to come on a given topic, and how might the results of those studies ultimately impact clinical guidelines on the topic(s).
So now let’s jump into the list of Juvenile Arthritis Clinical Trials!
Quick View Table of Juvenile Arthritis Clinical Trials
Juvenile Arthritis Clinical Trials:
Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (\>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for \>= 2 months.
- Interventions: DRUG: Golimumab|DRUG: Methotrexate
- Primary Outcomes Measures: Serum Trough Concentration (C-trough) of Golimumab, Serum golimumab trough concentration at Week 28 was reported., Week 28|Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28, AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling)., Week 28
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
- Sponsor: AbbVie
- “Psoriatic arthritis (PsA) is a type of arthritis that happens when the body’s immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient’s 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms.
- Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide.
- Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment.
- There may be a higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.”
- Interventions: DRUG: Adalimumab|DRUG: Risankizumab
- Primary Outcomes Measures: Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30), The JIA-ACR 30 response is defined as a \>= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without \>30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)., Up to 24 Weeks
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
- Sponsor: Pfizer
- A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase “time to sJIA flare” will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.
- Interventions: DRUG: In open-label phase: treatment with tofacitinib|DRUG: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
- Primary Outcomes Measures: Time to flare, Time to sJIA disease flare in the double-blind phase, Up to 82 weeks after randomization
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
- Sponsor: AbbVie
- “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.”
- Interventions: DRUG: Upadacitinib|DRUG: Tocilizumab
- Primary Outcomes Measures: 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
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
- Sponsor: Novartis Pharmaceuticals
- Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).
- Interventions: DRUG: AIN457
- Primary Outcomes Measures: “Number of participants with JIA ACR30 response, JIA ACR 30 is defined as 30% improvement from baseline in a minimum of three out of six variables with no more than one variable worsening more than 30% as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR 30 are:
- * Physician global assessment of overall disease activity
- * Parent’s or patients’ global assessment of patient’s overall well-being
- * Functional ability (CHAQ: Childhood Health Assessment Questionnaire)
- * Number of joints with active arthritis
- * Number of joint with limited range of motion
- * Index of inflammation: C-reactive Protein (CRP), 308 weeks”
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
- Interventions: DRUG: Ustekinumab|DRUG: Guselkumab
- Primary Outcomes Measures: Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups, Steady-state trough serum concentration of ustekinumab at Week 28 by baseline age groups will be reported., Week 28|Cohort 2: Steady-state Trough Serum Concentration of Guselkumab at Week 28 by Baseline Age Groups, Steady-state trough serum concentration of guselkumab at Week 28 by baseline age groups will be reported., Week 28|Cohort 1: Area Under the Curve at Steady-state (AUCss) Over a 12-Week Dosing Interval of Ustekinumab at Week 28 by Baseline Age Groups, AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 28 by baseline age groups., Week 28|Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 28 by Baseline Age Groups, AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 28 by baseline age groups., Week 28|Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24, Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30 percent (%) improvement (that is, a decrease in score) from baseline in greater than or equal to (\>=) 3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: physician global assessment (PGA) of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by childhood health assessment questionnaire (CHAQ) and C-reactive protein (CRP)., Week 24|Cohort 2: Percentage of Participants with jPsA Achieving ACR Pediatric 30 Response at Week 24, Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in \>=3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP., Week 24
Pediatric Arthritis Study of Certolizumab Pegol
- Sponsor: UCB BIOSCIENCES GmbH
- A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).
- Interventions: DRUG: Certolizumab Pegol (CZP)|DRUG: Certolizumab Pegol (CZP)
- Primary Outcomes Measures: “Certolizumab Pegol (CZP) Plasma Concentration level at Week 16, Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL., Week 16|Certolizumab Pegol (CZP) Plasma Concentration level at Week 48, Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL., Week 48|Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 16, Week 16|Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 48, Week 48|Incidence of serious treatment-emergent adverse events (TEAEs) during the study, A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- * Results in death
- * Is life-threatening
- * Requires in patient hospitalization or prolongation of existing hospitalization
- * Is a congenital anomaly or birth defect
- * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above, From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP)|Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of the Investigational Medicinal Product (IMP) during the study, An Adverse Event (AE) is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage., From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP)”
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
- Sponsor: Duke University
- This is a research study to test whether a once-weekly injection of abatacept will prevent the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic medication within 18 months of randomization in children with recent-onset limited JIA.
- Interventions: DRUG: Abatacept Injection|OTHER: Usual Care
- Primary Outcomes Measures: Change in Joint Count by Physician Exam (Part I), The number of affected joints involved at protocol specified visits by physician exam., Baseline, up to 18 months|Change in Joint Count by Physician Exam (Part II), The number of affected joints involved at protocol specified visits by physician exam., Baseline, up to 12 months|Change in Number of participants with active anterior uveitis (Part I), The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits, Baseline, up to 18 months|Change in Number of participants with active anterior uveitis (Part II), The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits, Baseline, up to 12 months
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
- Sponsor: Bristol-Myers Squibb
- The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
- Interventions: BIOLOGICAL: Abatacept
- Primary Outcomes Measures: Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17, Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be \>= 10 µg/mL., Day 113
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
- Sponsor: Pfizer
- Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
- Interventions: DRUG: Tofacitinib|DRUG: Tofacitinib
- Primary Outcomes Measures: Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collect to assess growth and physical development, up to 8 years
Potential Guideline That May Be Affected Includes:
- Treatment of Juvenile Idiopathic Arthritis (JIA): Therapeutic Approaches for Oligoarthritis, Temporomandibular Joint (TMJ) Arthritis and Systemic JIA
- American College of Rheumatology (ACR)
- Published: March 03, 2022
- Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non‐Systemic Polyarthritis, Sacroiliitis, and Enthesitis
- American College of Rheumatology (ACR)
- Publication: April 25, 2019
There you have it – a list of Phase 3 Clinical Trials for Juvenile Arthritis as of June 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.