Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

Inclusion Criteria:

- Subjects must be adults with a history of moderate to severe Rheumatoid Arthritis;

- Subjects must be in very good Rheumatoid Arthritis disease control for ≥ 6 months and
be in remission as defined by a Simplified Disease Activity Index ≤ 3.3 at screening
and at the end of the run-in period.

- Subjects must be on etanercept 50 mg per week plus methotrexate therapy for ≥ 6 months
prior to the start of the run-in period. The methotrexate dose must be 10 to 25 mg per
week for ≥ 6 months prior to the start of the run-in period and the dose must be
stable for ≥ 8 weeks prior to the start of the run-in period.

- Subject has no known history of active tuberculosis, and has a negative test for
tuberculosis during screening.

Exclusion Criteria:- Subject has used biologic disease modifying antirheumatic drug other
than etanercept OR has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit
1

- Subject has any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 4 weeks prior to run-in visit 1.

- Subject has known alcohol addiction or dependency or uses alcohol daily.

- Subject has one or more significant concurrent medical conditions per investigator
judgment, including the following:

- poorly controlled diabetes

- chronic kidney disease stage IIIb, IV, or V

- symptomatic heart failure (New York Heart Association class II, III, or IV)

- myocardial infarction or unstable angina pectoris within the past 12 months prior
to randomization

- uncontrolled hypertension

- severe chronic pulmonary disease (eg, requiring oxygen therapy)

- multiple sclerosis or any other demyelinating disease

- major chronic inflammatory disease or connective tissue disease other than
Rheumatoid Arthritis (eg, systemic lupus erythematosus with the exception of
secondary Sjögren's syndrome)