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

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.

Inclusion Criteria:

1. Patient and guardian are willing to consent to undergo up to 24 weeks of treatment
with 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, polyarthritis
rheumatoid factor (RF) +, polyarthritis RF-, psoriatic arthritis, enthesitis-related
arthritis, or undifferentiated and systemic arthritis without systemic features in
the 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 and
level of disease activity, it is determined appropriate for the patient to undergo up
to 24 weeks of treatment with DUEXIS (ibuprofen 800 mg/famotidine 26.6 mg) oral
tablet three times daily. The investigator will use his/her clinical judgment in
determining the duration of treatment for the patient based on the standard of care
up to 24 weeks of treatment.

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

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

8. For the single dose pharmacokinetic (PK) subset, patients and guardians must be
willing 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 use
medically acceptable methods of contraception, including abstinence, throughout the
entire study period.

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

Exclusion Criteria:

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

- NSAID-associated and/or primary peptic ulcer disease-associated serious
gastrointestinal complications such as perforation of ulcers, gastric outlet
obstruction 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 study
Day 0

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

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

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

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

4. 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.

5. Active uveitis.

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

7. Presence at screening or history of any disease other than JIA that requires the use
of 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 the
patient 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 patient
participated in an investigational drug study within the 30 days (or < 5 terminal
half-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 positive
urine pregnancy test at Study Day 0.

14. 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