Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

Inclusion Criteria:

1. Patient and guardian are willing to consent to undergo up to 24 weeks of treatmentwith DUEXIS (ibuprofen 800 mg/famotidine 26.6 mg) oral tablet three times daily.

2. Patient is male or female, aged 10 years to 16 years, 11 months.

3. Patient is diagnosed with JIA for > 1 month including oligoarthritis, polyarthritisrheumatoid factor (RF) +, polyarthritis RF-, psoriatic arthritis, enthesitis-relatedarthritis, or undifferentiated and systemic arthritis without systemic features inthe past 6 months.

4. Patient must have currently active articular disease as defined by > 1 active joint (i.e., presence of swelling, or if no swelling is present, limitation of motion [LOM] accompanied by pain, tenderness, or both).

5. Based upon investigator judgment, given current treatment patient is receiving andlevel of disease activity, it is determined appropriate for the patient to undergoup to 24 weeks of treatment with DUEXIS (ibuprofen 800 mg/famotidine 26.6 mg) oraltablet three times daily. The investigator will use his/her clinical judgment indetermining the duration of treatment for the patient based on the standard of careup to 24 weeks of treatment.

6. Weight > 48 kg and body mass index (BMI) > 5th percentile using the Centers forDisease Control (CDC) BMI percentile calculator for child and teen at the screeningvisit.

7. Patient is able to swallow a DUEXIS tablet whole.

8. For the single dose pharmacokinetic (PK) subset, patients and guardians must bewilling to participate in the serial blood sample collections at Day 0 and Week 4.

9. Female patients of childbearing potential and male patients must agree to usemedically acceptable methods of contraception, including abstinence, throughout theentire study period.

10. Patient is willing and able to comply with the prescribed treatment protocol andevaluations.

Exclusion Criteria:

1. Patient has a history of or experienced any of the following:

• NSAID-associated and/or primary peptic ulcer disease-associated seriousgastrointestinal complications such as perforation of ulcers, gastric outletobstruction due to ulcers, and/or acute gastrointestinal bleeding

• NSAID-induced asthma exacerbation, acute renal failure, interstitial nephritis,and/or hepatitis

• Malignant disease of the gastrointestinal tract

• Erosive esophagitis

• Coronary artery bypass graft (CABG) surgery within the 14 days prior to studyDay 0

• Uncontrolled diabetes mellitus as evidenced by Hemoglobin A1c > 7%

• Known history of human immunodeficiency virus (HIV), hepatitis B, and/orhepatitis C.

2. Current symptoms of severe, progressive, or uncontrolled renal, hepatic,hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebraldisease.

3. JIA disease is severe as defined by either physician's or parent's globalassessments > 90 on a 100 point scale.

4. Systemic JIA with any of the following manifestations within the last 6 months priorto enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly,pleuritis, pericarditis, or macrophage activation syndrome.

5. Active uveitis.

6. Presence of any other rheumatic disease or major chronic infectious, inflammatory,immunologic disease (e.g., inflammatory bowel disease, hypogammaglobulinemia, orsystemic lupus erythematosus, etc.).

7. Presence at screening or history of any disease other than JIA that requires the useof chronic systemic corticosteroids.

8. History of clinically significant drug or alcohol abuse.

9. Presence at screening of any of the following laboratory values:

• Hemoglobin < 9.0 g/dL

• White blood cells < 2000/mm^3 (2 x 109/L)

• Platelets < 150,000/mm^3 (150 x 109/L)

• Serum creatinine > 1.5 times upper limit of normal

• Serum ALT or AST > 2.0 times upper limit of normal

• H. pylori positive

• Any other lab value that in the opinion of the investigator might place thepatient at unacceptable risk for participation in this study.

10. Methotrexate > 20 mg/M^2/week or > 40 mg/week.

11. Patient currently is participating in an investigational drug study, or patientparticipated in an investigational drug study within the 30 days (or < 5 terminalhalf-lives of elimination) prior to study entry.

12. Females who are pregnant or breast feeding.

13. Female patient has a positive serum pregnancy test at Screening and/or a positiveurine pregnancy test at Study Day 0.

14. Patient has a concomitant disease or condition that, in the opinion of theInvestigator, could interfere with the conduct of the study or could put the patientat unacceptable risk