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
  • Robin K. Dore M.D., Inc. in progress, not accepting new patients
    Tustin, California, 92780, United States
  • Talbert Medical Group in progress, not accepting new patients
    Huntington Beach, California, 92646, United States
  • Advances In Medicine in progress, not accepting new patients
    Rancho Mirage, California, 92270, United States
  • Medvin Clinical Research in progress, not accepting new patients
    Placentia, California, 92870, United States
  • ProHealth Partners in progress, not accepting new patients
    Long Beach, California, 90808, United States
  • Valerius Medical Group And Research Center Of Greater Long Beach, Inc. terminated
    Long Beach, California, 90806, United States
  • Medvin Clinical Research in progress, not accepting new patients
    Whittier, California, 90602, United States
  • Investigational Drug Service in progress, not accepting new patients
    Torrance, California, 90502, United States
  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center in progress, not accepting new patients
    Torrance, California, 90502, United States
  • Harbor UCLA Medical Center in progress, not accepting new patients
    Torrance, California, 90509, United States
  • Medvin Clinical Research in progress, not accepting new patients
    Covina, California, 91722, United States
  • Keck Medicine of USC terminated
    Los Angeles, California, 90033, United States
  • University of Southern California (USC) Norris Comprehensive Cancer Center terminated
    Los Angeles, California, 90033, United States
  • Dr. Orrin M. Troum, Md And Medical Associates in progress, not accepting new patients
    Santa Monica, California, 90404, United States
  • Desert Valley Medical Group in progress, not accepting new patients
    Victorville, California, 92395, United States
  • Medvin Clinical Research in progress, not accepting new patients
    Van Nuys, California, 91405, United States
  • California Medical Research Associates Inc in progress, not accepting new patients
    Northridge, California, 91324, United States
  • Ventura Clinical Trials in progress, not accepting new patients
    Ventura, California, 93003, United States
  • University of Nevada School of Medicine in progress, not accepting new patients
    Las Vegas, Nevada, 89102, United States
  • Steinberg Diagnostics in progress, not accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Access Health / Davis Group, Ltd. in progress, not accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Access Health in progress, not accepting new patients
    Las Vegas, Nevada, 89128, 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
May 24, 2018