Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis

This is a prospective, noninterventional (no treatment medication provided by the study),
observational (study in which the investigators/ physicians observe the patients and measure
their outcomes), multicenter (study conducted at multiple sites) study of Golimumab IV and
Infliximab in RA patients. The study allows for an anticipated 2-year enrollment period and a
3-year study duration for each patient. No interventions will be given to patients as a part
of this study. This study will be conducted in the US, at rheumatology-based clinical
practices and will enroll adult RA patients who meet all entry criteria. The primary endpoint
of this study is the proportion of patients with an infusion reaction through week 52.
Patients will be enrolled in a 1:1 ratio to initiate treatment with either Golimumab IV or
Infliximab. Patients' safety will be monitored throughout the study.

Inclusion Criteria:

- Patient must be a male or female 18 years of age or older as the study is intended to
assess Golimumab intravenous (IV) and Infliximab in adult RA patients

- Patient must sign an informed consent form (ICF) indicating that he or she understands
the purpose of and procedures required for the study and is willing to participate in
the study

- Patient has a confirmed diagnosis of Rheumatoid arthritis (RA) and is medically
eligible for treatment with Golimumab IV or Infliximab in accordance with standard of
care (example, screening for tuberculosis [TB], vaccinations, etc.)

- At the time of enrollment the patient will be initiating treatment with Golimumab IV
or Infliximab. The patient may or may not have previously received treatment with a
biologic. Patients with previous exposure to subcutaneously administered Simponi may
enroll in the study

- Patient must be willing to complete Patient reported outcomes (PRO) forms during the
study and agree to return completed forms to the site if receiving an infusion of
Golimumab IV or Infliximab at a location remote from the study site

Exclusion Criteria:

- Patient is less than 18 years of age

- Patient is pregnant or planning a pregnancy

- Patient is currently enrolled in an interventional study

- Patient has received an investigational drug (including investigational vaccines) or
used an invasive investigational medical device within 28 days, as appropriate, before
the planned first dose of Golimumab IV or Infliximab

- Patient previously received Golimumab IV if planning to receive Golimumab IV in this
study or the patient previously received Infliximab if planning to receive Infliximab
or BI in this study. Patient previously receive BI if planning to receive BI or
Remicade in this study

- Patient has any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the patient (example, compromise the patient's
well-being) or that could prevent, limit, or confound the protocol-specified
assessments