A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor patient knows the treatment that the patient receives), multicenter,
placebo-controlled (an inactive substance that is compared with a drug to test whether the
drug has a real effect in a clinical trial), parallel-group (each group of patients will be
treated at the same time), dose range finding study of JNJ-38518168 in patients with active
RA despite concomitant MTX therapy. The study will consist a screening period, a 24-week
placebo-controlled period and a 4-week follow-up period between the last dose and the last
visit. The duration of participation in the study for an individual patient will be up to 34
weeks (including screening). The patients will be assigned to 1 of 4 treatment groups in a
1:1:1:1 ratio to placebo and JNJ-38518168 (3 mg or 10 mg or 30 mg). Safety assessments and
evaluations to determine the efficacy of JNJ-38518168 to reduce the signs and symptoms of RA
will be performed at study visits. Safety will be monitored throughout the study.

Inclusion Criteria:

- Has had rheumatoid arthritis for at least 6 months prior to the date of signing the
informed consent at screening

- Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid
factor in serum at screening

- Must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a
66/68 joint count at the time of screening and at baseline and Serum C reactive
protein greater than or equal to 0.80 mg/dL at the time of screening

- Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25
mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks
prior to the date of signing the informed consent at screening

Exclusion Criteria:

- Has inflammatory diseases other than rheumatoid arthritis, including but not limited
to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic
lupus erythematosus, and Lyme disease that might confound the evaluation of the
benefit of study agent therapy

- Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular,
pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or
metabolic disturbances that are severe, progressive or uncontrolled

- Has ever received any approved or investigational biologic agent for a rheumatoid
indication

- Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4
weeks prior to the first administration of study agent