A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)

A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)

A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.

Study with completed results acquired from Horizon in 2024.

Inclusion Criteria:

• Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.
• Male and female adolescents aged 12 to 16 years at the time of enrollment.
• Diagnosed with JIA, including all the International League of Associations for Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor [RF]+ and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis, and systemic arthritis.
• Based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with VIMOVO.
• Body weight > 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.

Exclusion Criteria:

• In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.
• Currently taking (ie, within 4 weeks prior to start of drug) naproxen > 20 mg/kg/day or > 1000 mg total daily dose.
• Hemoglobin ≤ 8.5 g/dL.
• Individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.
• Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.