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, RheumatoidPost-marketingPhase 4Open-labelSafety SurveillanceCP690550Xeljanzoral treatmentArthritisNecrosisAdalimumabEtanerceptTofacitinib

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 JollaCalifornia92037United States
  • San Diego Arthritis Medical Clinic in progress, not accepting new patients
    San DiegoCalifornia92108United 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