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

Completed · Phase 4

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT02092467

Run by

Pfizer

People needed

4372

Starts

2014-03-14

Expected to finish

2020-07-22

Last updated by the study team

2021-08-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States
• Clinical and Translational Research Center of Alabama, PC — Tuscaloosa, Alabama, United States
• Southern Arizona VA Health Care System (SAVAHCS) — Tucson, Arizona, United States
• University of Arizona Clinical and Translational Science Research Center — Tucson, Arizona, United States
• CHI St. Vincent Medical Group Hot Springs — Hot Springs, Arkansas, United States
• Arthritis And Rheumatism Associates LLC — Jonesboro, Arkansas, United States
• Medvin Clinical Research — Covina, California, United States
• Med Investigations, Inc. — Fair Oaks, California, United States
• Talbert Medical Group — Huntington Beach, California, United States
• University of California, San Diego (UCSD)- Perlman Ambulatory Clinic — La Jolla, California, United States
• Valerius Medical Group And Research Center Of Greater Long Beach, Inc. — Long Beach, California, United States
• ProHealth Partners — Long Beach, California, United States
• Keck Medicine of USC — Los Angeles, California, United States
• California Medical Research Associates Inc — Northridge, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Medvin Clinical Research — Placentia, California, United States
• Sierra Rheumatology, Inc. — Roseville, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Dr. Orrin M. Troum, Md And Medical Associates — Santa Monica, California, United States
• Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center — Torrance, California, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• Robin K. Dore M.D., Inc. — Tustin, California, United States
• Medvin Clinical Research — Van Nuys, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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