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

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.