Summary

for people ages 50 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Arthritis, Rheumatoid Post-marketing Phase 4 Open-label Safety Surveillance CP690550 Xeljanz oral treatment Arthritis Necrosis Adalimumab Etanercept Tofacitinib

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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 CAN'T join if...

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

Locations

  • University of California, San Diego (UCSD)- Perlman Ambulatory Clinic in progress, not accepting new patients
    La Jolla California 92037 United States
  • San Diego Arthritis Medical Clinic in progress, not accepting new patients
    San Diego California 92108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02092467
Phase
Phase 4
Study Type
Interventional
Last Updated
October 2, 2018