PoC in Rheumatoid Arthritis With Methotrexate

Inclusion Criteria:

- Must have a diagnosis of RA for at least 6 months

- Must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg
weekly) for 4 weeks before dosing with study medication

- Must have at least 6 swollen and at least 8 tender joints

- CRP above upper limit of normal or ESR > 28 mm/hr

- Must wash-out (stop taking) other immunosuppressant medications to treat RA (except
for methotrexate) before dosing with study medication

Exclusion Criteria:

- Any infection including TB, HIV, Hepatitis B or C

- Recent infection requiring antibiotics within 4 weeks

- History of gastrointestinal disease (such as GERD, gastrointestinal ulcers,
heartburn) requiring medical or surgical treatment within 3 months

- Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2
blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta,
Maalox)