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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Esomeprazole; Naproxen

Criteria

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.