A Study Comparing the Safety of Tofacitinib versus Tumor Necrosis Factor Inhibitor in Patients with Rheumatoid Arthritis


About this study

The purpose of this post-marketing study is to compare the safety of tofacitinib versus tumor necrosis factor inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers, when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and effectiveness parameters will be collected and evaluated in the study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Moderate to severe rheumatoid arthritis
  • Taking methotrexate without adequate control of symptoms
  • Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)


Exclusion Criteria

  • Current or recent infection
  • Clinically significant laboratory abnormalities
  • Pregnancy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

John Davis, M.D.

Closed for enrollment

More information


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