A Phase 3, randomized, double-blind, placebo-controlled, study of the efficacy and safety of 2 doses of Tofacitinib (CP 690,550) - Bronson Healthcare

OPAL BEYOND

A Phase 3, randomized, double-blind, placebo-controlled, study of the efficacy and safety of 2 doses of Tofacitinib (CP 690,550) in subjects with active psoriatic arthritis and inadequate response to at least one TNF inhibitor

Objective

This study is designed to examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

Eligible patients will have:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening
  • Inadequate response or lack of toleration to previously administered TNF inhibitor
ClinicalTrials.Gov Number
NCT01882439
Principal Investigator(s)
Robert Shurmur, DO
Sponsor(s)
Pfizer, Inc.
Contact
Jennifer Jenkins, LPN, CCRC at 269-979-6333
or jenkinje@bronsonhg.org
How to Participate

Participants will be randomly assigned to one of three dosing patterns for the investigational drug or placebo. The effects of the drug on the disease will be evaluated in addition to studying the safety of the drugs. About 390 patients will enroll at multiple centers. More information can be found here.

Location

  • Bronson Internal Medicine & Rheumatology (A department of Bronson Battle Creek Hospital)
    2845 Capital Ave. SW
    Suite 302
    Battle Creek, MI 49015
    Main: 269-979-6333
    Fax: 269-979-6335