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



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:50 - Any
Updated:2/8/2019
Start Date:March 14, 2014
End Date:March 3, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

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.


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
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1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
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2201 Inwood Rd
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1521 Gull Rd
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