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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: tofacitinib; Biological: adalimumab; Biological: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02092467

A3921133

2013-003177-99 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 4,372 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,372 participants in 3 patient groups

Treatment Arm 1

Experimental group

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Treatment Arm 2

Experimental group

Treatment:

Drug: tofacitinib

Drug: tofacitinib

Treatment Arm 3

Active Comparator group

Description:

TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.

Treatment:

Biological: etanercept

Biological: adalimumab