Status and phase
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About
The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks.
The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
Full description
Approximately 30 JIA patients who meet all eligibility criteria and who are expected to require daily administration of an NSAID for up to 24 weeks will be enrolled. A subset of approximately 6 patients will participate in a single dose PK study at Day 0 with an abbreviated PK profile performed at Week 4 if possible. Multiple dose PK sampling will occur in all enrolled patients.
Study with completed results acquired from Horizon in 2024
Enrollment
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Inclusion criteria
Exclusion criteria
Patient has a history of or experienced any of the following:
Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
JIA disease is severe as defined by either physician's or parent's global assessments > 90 on a 100 point scale.
Systemic JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
Active uveitis.
Presence of any other rheumatic disease or major chronic infectious, inflammatory, immunologic disease (e.g., inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus, etc.).
Presence at screening or history of any disease other than JIA that requires the use of chronic systemic corticosteroids.
History of clinically significant drug or alcohol abuse.
Presence at screening of any of the following laboratory values:
Methotrexate > 20 mg/M^2/week or > 40 mg/week.
Patient currently is participating in an investigational drug study, or patient participated in an investigational drug study within the 30 days (or < 5 terminal half-lives of elimination) prior to study entry.
Females who are pregnant or breast feeding.
Female patient has a positive serum pregnancy test at Screening and/or a positive urine pregnancy test at Study Day 0.
Patient has a concomitant disease or condition that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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