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Select Ongoing Trials Currently Enrolling Patients with Juvenile Idiopathic Arthritis

Rheumatology Practice Management December 2017 Vol 5 No 6 - Clinical Trials Tracker

 

The following clinical trials represent a selection of key studies that are currently recruiting patients with juvenile idiopathic arthritis (JIA) for inclusion in investigations of new therapies and new regimens of existing treatments for individuals with the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1. Pharmacokinetics, Safety, and Efficacy of Sarilumab in Patients with Polyarticular Juvenile Idiopathic Arthritis

The objective of this open-label, single-group, phase 2 clinical trial is to define the pharmacodynamics and assess the safety and efficacy of using subcutaneous sarilumab for the treatment of children and adolescents with polyarticular JIA. Patients aged 2 to 17 years with a diagnosis of polyarticular JIA or oligoarticular-extended JIA according to the International League of Associations for Rheumatology (ILAR) 2001 Juvenile Idiopathic Arthritis classification criteria and a body weight of 60 kg may be eligible for enrollment if other criteria are met. Eligible patients will receive 1 of 3 ascending doses of sarilumab, depending on body weight.

The primary outcome measure is the pharmacokinetic profile of saril­umab. The secondary outcome measures include adverse events, local-site reactions, and JIA American College of Rheumatology 30 (ACR 30) response rates. This study plans to enroll 36 patients at multiple locations across the United States or abroad. For more information, e-mail contact-us@sanofi.com. The NLM Identifier is NCT02776735.

2. Safety and Efficacy of Tofacitinib in Patients with Systemic Juvenile Idiopathic Arthritis

This randomized, sequential-assignment phase 3 clinical trial will determine the safety and efficacy of using tofacitinib for the treatment of patients with systemic JIA. Patients aged 2 to 17 years who have active systemic JIA diagnosed in accordance with ILAR criteria for ≥6 weeks before screening and who have not received previous treatment with tofacitinib may be eligible for enrollment if other criteria are met. All eligible patients will be given tofacitinib or placebo.

The primary outcome measure is time to systemic JIA disease flare. The secondary outcome measures include the occurrence of disease flares, achievement of corticosteroid tapering, and time to first adapted JIA ACR30 response. This study expects to enroll 100 patients at centers in New York and Ohio. For more information, contact the Pfizer CT.gov Call Center at 800-718-1021 or clinicaltrials.gov_inquiries@pfizer.com. The NLM Identifier is NCT03000439.

3. Efficacy, Safety, and Pharmacokinetics of Reduced-Dose Tocilizumab

The objective of this parallel-assignment, open-label, phase 4 clinical trial is to assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of using reduced-dose tocilizumab in the treatment of patients with adequately controlled systemic JIA who had a laboratory abnormality with twice-weekly dosing that has since been resolved.

Patients aged 2 to 17 years with systemic JIA diagnosed in accordance with ILAR 2001 classification criteria who have a Juvenile Arthritis Disease Activity Score (JADAS)-71 ≤3.8 and no systemic JIA–related fever at screening and baseline may be eligible for enrollment if other criteria are met. Eligible patients will receive tocilizumab in a reduced-dose frequency.

The primary outcome measures are the number of patients with fever during part 2 of the study, the number of patients who have adverse events, JADAS-71 scores at the end of part 2 of the study, and the number of patients with JIA disease flares.

The secondary outcome measures include maximum and minimum observed plasma trough concentrations, soluble interleukin-6 receptor protein concentrations, and C-reactive protein concentrations during part 2 of the study. This study plans to enroll 65 patients at multiple locations across the United States or abroad. For more information, contact 888-662-6728 or global.roche genentechtrials@roche.com. The NLM Identifier is NCT01734382.

4. Efficacy and Safety of Canakinumab Dose Reduction or Dose Interval Prolongation

This nonrandomized, open-label, parallel-assignment phase 3 clinical trial will determine the efficacy and safety of using canakinumab at a reduced dose or prolonged dose interval in the first-line treatment of patients with systemic JIA. Patients aged 2 to 20 years with systemic JIA diagnosed in accordance with ILAR criteria may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive canakinumab at a reduced dose or prolonged dose interval.

The primary outcome measure is the proportion of patients who achieve clinical remission with canakinumab and who can remain at an initial reduced dose or prolonged dose interval. The secondary outcome measure is percentage of patients who have adverse events. This study expects to enroll 180 patients at multiple locations across the United States or abroad. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT02296424.

5. Pharmacokinetics of Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis

The objective of this multicenter, single-group, open-label phase 3 clinical trial is to assess the pharmacokinetics of intravenous golimu­mab in pediatric patients with polyarticular JIA that includes ≥5 joints with active arthritis despite treatment with methotrexate for ≥2 months. Patients aged 2 to 17 years with polyarticular JIA diagnosed in accordance with ILAR classification criteria whose disease was unresponsive or inadequately responded to treatment with methotrexate for ≥2 months may be eligible for enrollment if other criteria are met. Eligible patients will receive golimumab plus methotrexate.

The primary outcome measures are the serum trough concentration of golimumab at week 28, and the Bayesian area under the curve at a steady state over the course of 1 dosing interval of 8 weeks. The secondary outcome measures are the serum trough concentration of golimumab and the Bayesian area under the curve at a steady state at week 52. This study plans to enroll 120 patients at multiple locations across the United States or abroad. For more information, e-mail JNJ.CT@sylogent.com. The NLM Identifier is NCT02277444.

6. Use of Denosumab in Patients with Rheumatic Disorders Treated with Glucocorticoids

This randomized, parallel-assignment, phase 1/2 clinical trial will evaluate the use of denosumab for the treatment of bone loss in patients with rheumatic disorders, including JIA, who are receiving glucocorticoids. Patients aged 4 to 16 years who are diagnosed with JIA or another specified rheumatic disorder who have been receiving treatment with glucocorticoids for up to 1 month may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive denosumab or no drug intervention.

The primary outcome measures are the changes in bone turnover marker. The secondary outcome measures include changes in bone-specific alkaline phosphorus, changes in the polar strength-strain index, and dose-limiting toxicities. This study expects to enroll 24 patients at the Indiana University School of Medicine, Indianapolis. For more information, contact Marian Hart at 317-948-8346 or marihart@iu.edu, or Connie Sullivan at 317-944-8431. The NLM Identifier is NCT02418273.

7. Long-Term Safety and Tolerability of Tofacitinib in Patients with Juvenile Idiopathic Arthritis

The objective of this single-group, open-label, phase 3 clinical trial is to assess the long-term safety and tolerability of using tofacitinib in patients with JIA who participated in previous clinical trials of tofacitinib. Patients aged 2 to 18 years with JIA whose disease activity warrants the use of tofacitinib as a disease-modifying antirheumatic drug and who do not have chronic infections may be eligible for enrollment if other criteria are met. Eligible patients will receive tofacitinib.

The primary outcome measures are standard laboratory safety data and reports of adverse events. The secondary outcome measures include the number of joints with active arthritis or limitation of motion at each visit, index of inflammation at each visit, and Parent’s Assessment of Physical Function via the Childhood Health Assessment Questionnaire (CHAQ)-Disability Index at each visit. This study plans to enroll 340 patients at multiple locations across the United States or abroad. For more information, contact the Pfizer CT.gov Call Center at 800-718-1021 or clinicaltrials.gov_inquiries@pfizer.com. The NLM Identifier is NCT01500551.

8. Pharmacokinetics of Sarilumab for Patients with Systemic Juvenile Idiopathic Arthritis

This single-group, open-label, dose-finding, phase 2 clinical trial will determine the pharmacokinetic profile of sarilumab use in patients with systemic JIA, with the goal of identifying the dose and regimen for continued development in this patient population. Patients aged 1 to 17 years with systemic JIA diagnosed in accordance with ILAR 2001 classification criteria may be eligible for enrollment if other criteria are met. Eligible patients will receive sarilumab.

The primary outcome measure is the pharmacokinetic profile of saril­umab in patients with systemic JIA. The secondary outcome measures are the pharmacodynamics, efficacy, and long-term safety of sarilumab in this patient population. This study expects to enroll 36 patients at multiple locations across the United States or abroad. For more information, e-mail contact-us@sanofi.com. The NLM Identifier is NCT02991469.

9. Safety and Efficacy of Subcutaneous Tocilizumab

The objective of this single-group, open-label, phase 1 clinical trial is to evaluate the safety and efficacy of using subcutaneous tocilizumab for the treatment of patients with polyarticular JIA and systemic JIA. Patients aged 2 to 18 years who took part in and completed either of the JIGSAW trials, trial WA28117 (for patients with polyarticular JIA), or trial WA28118 (for patients with systemic JIA), and whose disease is adequately controlled with the use of subcutaneous tocilizumab may be eligible for enrollment if other criteria are met. Eligible patients will receive subcutaneous tocilizumab.

The primary outcome measures are JADAS-71 scores, and the percentage of patients who have adverse events. The secondary outcome measures are CHAQ scores, and the percentage of patients who have protocol-defined inactive disease or clinical remission. This study plans to enroll 96 patients at multiple locations across the United States or abroad. For more information, contact 888-662-6728 or global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02165345.

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Last modified: February 23, 2018
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