A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

This is a randomized (participants assigned to treatment by chance), double-blind
(participants and study personnel will not know what treatment is being given),
placebo-controlled (a placebo appears identical to a study drug, but contains no active
ingredients), parallel-group (treatments will be given to groups of participants at the same
time) study. Participants will be randomly assigned in a 3:1 ratio to receive either
JNJ-38518168 for 52 weeks or receive matching placebo for 12 weeks, followed by JNJ-38518168
for 40 weeks. The total duration of participation will be approximately 60 weeks for all
participants, including a screening visit and follow-up visits. Safety and tolerability of
JNJ-38518168 will be evaluated by monitoring adverse events reported by participants
throughout the study . In addition, results from clinical laboratory tests,
electrocardiograms, vital signs measurements, and physical examinations performed during the
study will be monitored.

Inclusion Criteria:

- Have had rheumatoid arthritis (RA) for at least 6 months prior to the date of signing
the informed consent at screening

- Be positive for either anti-cyclic citrullinated peptide (anti-CCP) antibody or
rheumatoid factor (RF) in serum at screening

- Have active RA defined for the purpose of this study as persistent disease activity
with both of the following criteria: At least 4 swollen and 4 tender joints using a
66/68 joint count. At the time of screening, one of the tender or swollen joints or
both must include the non-prosthetic knee to be biopsied; and serum C-reactive
protein (CRP_ ≥ 0.60 mg/dL at screening

- Have been treated with and tolerated oral methotrexate (MTX) treatment at doses from
10 mg/week to 25 mg/week inclusive, for a minimum of 3 months prior to the date of
signing the informed consent at screening and must have a stable MTX dose for a
minimum of 8 weeks prior to the date of signing the informed consent at screening and
continue to receive the same MTX dose at Week 0

- If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain
relievers) regularly for RA, the participant must have been on a stable dose for at
least 2 weeks prior to the first administration of study agent. If not using NSAIDs
or other analgesics for RA at Week 0, the participant must have not received NSAIDs
or other analgesics for RA for at least 2 weeks prior to the first administration of
study agent

Exclusion Criteria:

- Has inflammatory diseases other than RA

- Has a history of juvenile idiopathic arthritis (JIA)

- 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