Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

Summary

This post-marketing study is designed to compare the safety of tofacitinib versus TNF 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 efficacy parameters will be collected and evaluated in the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Adalimumab; Etanercept; Tofacitinib

Criteria

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