Summary

for people ages 50 years and up (full criteria)
at UCLA UCSD
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
    La Jolla California 92037 United States
  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
    Torrance California 90502 United States
  • Harbor UCLA Medical Center
    Torrance California 90509 United States
  • The Lundquist Institute at Harbor-UCLA Medical Center
    Torrance California 90509 United States
  • Dr. Orrin M. Troum, Md And Medical Associates
    Santa Monica California 90404 United States
  • Robin K. Dore M.D., Inc.
    Tustin California 92780 United States
  • Talbert Medical Group
    Huntington Beach California 92646 United States
  • San Diego Arthritis Medical Clinic
    San Diego California 92108 United States
  • Medvin Clinical Research
    Van Nuys California 91405 United States

Details

Status
in progress, not 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