Golimumab in Rheumatoid Arthritis Patients With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

The main purpose of this study is to assess the effects (good and bad) of golimumab for
rheumatoid arthritis (RA) in patients previously treated with another tumor necrosis factor
(TNF) inhibitor. Golimumab is a type of TNF inhibitor. TNF is a naturally occurring
substance in the body and this substance may cause long-term inflammation. Golimumab may
help fight your disease by blocking the activity of TNF in your body. This study will assess
the safety of golimumab and determine if there is a reduction of the pain and swelling in
the joints of patients with rheumatoid arthritis treated with golimumab. The effect of
golimumab on physical function, and the quality of life in patients with rheumatoid
arthritis will also be assessed. Golimumab will be given by a subcutaneous injection (SC)
every 4 weeks at doses of 50 mg and possibly by intravenous injection (IV) every 8 weeks at
2 mg/kg. Golimumab is given by a SC injection with a needle inserted under your skin in the
back of your upper arm, your upper thigh, stomach area or by IV in your arm. If you are
eligible to take part in this study, you will initiate treatment with open-label golimumab
SC injections every 4 weeks. During the first 12 weeks you and your doctor will know what
medication you are receiving, this is called open-label. Starting at Week 16, depending on
how your RA has improved, you will be put into one of three groups where each group gets a
different treatment. If your study doctor sees an improvement of in your disease you can
continue to receive an injection of golimumab 50 mg SC every 4 weeks through Week 48. If
your disease has not improved you will be randomly placed into one of two study groups. You
will have approximately a one in three chance of being put in the group receiving golimumab
50mg SC every four weeks along with placebo drug IV every eight weeks and a two in three
chance of being put in the group receiving 2mg/kg IV every eight weeks along with placebo SC
every four weeks. Starting with Week 16 if you are placed in Group 1, the study will remain
open labeled. If you are randomized to Groups 2a or 2b, the study is "blinded." This means
that neither you nor your study doctor will know in which group you are placed. However, if
needed for safety or health reasons, your study doctor can find out your treatment at any
time. Placebo is an inactive treatment that looks the same as the study drug golimumab, but
does not contain any active medication. Your disease will be measured by your physician
using standards called American College of Rheumatology (ACR) 20 and Disease Activity Score
(DAS) 28. For example, if a study reported that 55% of patients achieved ACR20, that means
55% of patients in the study achieved a 20% improvement in tender or swollen joint counts as
well as 20% improvement in three of the other five criteria. DAS28 is based on counts of
the number of painful joints and the number of swollen joints you have out of 28 joints.
All patients will receive golimumab 50 mg subcutaneous injection every 4 weeks +
methotrexate for 16 weeks. Patients whose disease shows pronounced improvement will continue
to receive this therapy every 4 weeks for 36 more weeks. Patients who do not achieve a
DAS-28 "good" response, as defined by EULAR criteria, will receive either golimumab 50 mg
subcutaneous injection every 4 weeks + methotrexate for 36 more weeks OR golimumab 2 mg/kg
IV every 8 weeks + methotrexate for 34 more weeks.