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

This is an interventional treatment trial for Rheumatoid Arthritis Read More

Inclusion Criteria (Part 1, Run-In Period):

• 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 (Part 1, Run-In Period):

• 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)

Inclusion Criteria (Part 2, Treatment Period):

• SDAI ≤ 3.3 at run-in visit 3
• Subject if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative urine pregnancy test at baseline (day 1).

Exclusion Criteria (Part 2, Treatment Period):

• Any clinically significant change in the Part 1 eligibility criteria during the run-in period
• SDAI > 3.3 and ≤ 11 on two consecutive visits at least two weeks apart OR SDAI > 3.3 and ≤ 11 on two or more separate visits OR SDAI > 11 at any time during the run-in period
• Subject has a clinically significant laboratory abnormality during run-in period which in the opinion of the investigator poses a safety risk, will prevent the subject from completing the study, or will interfere with the interpretation of the study results during the run-in period.

NOTE: Other inclusion/exclusion criteria may apply per protocol.