Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:50 - Any
Updated:4/6/2019
Start Date:March 14, 2014
End Date:March 3, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

- 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)

Exclusion Criteria:

- Current or recent infection

- Clinically significant laboratory abnormalities

- Pregnancy
We found this trial at
157
sites
Borgess Medical Center
1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Borgess Research Institute
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
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Advanced Medical Research Center
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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Harbor UCLA Medical Center
1000 W Carson St
Torrance, California 90502
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Amarillo Center for Clinical Research
Amarillo, Texas 79124
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Arthritis and Rheumatology of GA, P.C.
Atlanta, Georgia 30342
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Austin Regional Clinic
Austin, Texas 78731
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Bronson Healthcare Group - Bronson Internal Medicine and Rheumatology
2845 Capital Avenue Southwest
Battle Creek, Michigan 49015
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Bronson Healthcare Group
485 East Columbia Avenue
Battle Creek, Michigan 49015
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University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program
Birmingham, Alabama 35294
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Birmingham, AL
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Clinical Research Services
Bismarck, North Dakota 58501
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Dorothy Sander, RPh
Bismarck, North Dakota 58501
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St. Alexius Medical Center Inpatient Pharmacy
Bismarck, North Dakota 58501
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RASF Clinical Research Center
Boca Raton, Florida
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Bay Area Arthritis and Osteoporosis
Brandon, Florida 33511
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Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York 11201
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Consultorios Reumatologicos Pampa.
C.a.b.a., Buenos Aires
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Medical Associates of North Georgia
Canton, Georgia 30114
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Trinity Universal Research Associates, Inc
Carrollton, Texas 75007
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Low Country Rheumatology
Charleston, South Carolina 29406
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Rheumatology Associates
Charleston, South Carolina 29407
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Center for Arthritis and Rheumatic Diseases
Chesapeake, Virginia 23320
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Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio 45219
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Florida Clinical Research Group
Clearwater, Florida 33759
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Arthritis and Rheumatism Associates
612 Druid Road
Clearwater, Florida 33756
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Dr.Robert W. Levin MDOffice of
1831 North Belcher Road
Clearwater, Florida 33765
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Summit Medical Group
Clifton, New Jersey 07012
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
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Arthritis Associates And Osteoporosis Center Of Colorado Springs
Colorado Springs, Colorado 80910
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Medvin Clinical Research
Covina, California 91723
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Klein & Associates, MD, PA
Cumberland, Maryland 21502
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Pioneer Research Solutions
Cypress, Texas 77429
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Arthritis Centers of Texas
Dallas, Texas
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U.T. Southwestern Medical Center
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Harold C. Simmons Comprehensive Cancer Center-University of Texas Southwestern Medical Center
2201 Inwood Road
Dallas, Texas 75390
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University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas 75390
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Baylor Scott and White Research Institute / Arthritis Care and Research Center
Dallas, Texas 75231
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STAT Research, Inc.
Dayton, Ohio 45417
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International Medical Research
Daytona Beach, Florida 32117
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Office of Jefrey D. Lieberman, MD, PC
Decatur, Georgia 30033
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Decatur, GA
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Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
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EmergeOrtho,P.A.
Durham, North Carolina 27704
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
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Med Investigations
Fair Oaks, California 95628
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Phase III Clinical Research
Fall River, Massachusetts 02720
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Centre for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida 33334
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Arthritis Treatment Center
Frederick, Maryland 21702
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Frederick, MD
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Rheumatic Disease Center
Glendale, Wisconsin 53217
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Northwell Health - merge
Great Neck, New York 11021
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Physician's East
Greenville, North Carolina 27834
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Piedmont Arthritis Clinic, PA
Greenville, South Carolina 29601
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Innovative Clinical Research
7021 Augusta Road
Greenville, South Carolina 29604
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Klein & Associates MD, PA.
Hagerstown, Maryland 21740
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PMG Research of Hickory, LLC
Hickory, North Carolina 28602
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Frycare outpatient imaging Center
1781 Tate Boulevard Southeast
Hickory, North Carolina 28602
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CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
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Accurate Clinical Management
Houston, Texas 77004
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Rheumatic Disease Clinical Research Center
Houston, Texas 77004
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Accurate Clinical Research
Houston, Texas
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Houston Institute for Clinical Research
Houston, Texas 77024
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Accurate Clinical Management
Houston, Texas 77004
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Medical Center Research, LLC
Houston, Texas 77089
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Talbert Medical Group
Huntington Beach, California 92646
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
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Rheumatology Associates of N. Alabama, PC
Huntsville, Alabama 35801
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
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West Tennessee Research Institute
Jackson, Tennessee 38305
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University of Florida College of Medicine, Jacksonville - Rheumatology Research
Jacksonville, Florida 32207
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University of Florida, Rheumatology at ACC
Jacksonville, Florida 32207
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UF Health-Rheumatology
4555 Hart Expressway
Jacksonville, Florida 32207
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University of Florida College of Medicine Jacksonville
Jacksonville, Florida 32209
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Arthritis And Rheumatism Associates LLC
Jonesboro, Arkansas 72401
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Jasper Clinic, Inc.
Kalamazoo, Michigan 49007
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Western Michigan University School Of Medicine
300 Portage Street
Kalamazoo, Michigan 49008
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Glacier View Research Institute
Kalispell, Montana 59901
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Glacier View Research Institute(Regulatory/Administrative)
Kalispell, Montana 59901
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Kansas City Internal Medicine
Kansas City, Missouri 64114
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
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University of California, San Diego (UCSD) - Perlman Ambulatory Clinic
La Jolla, California 92093
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NYU Langone Rheumatology Associates Long Island
Lake Success, New York 11042
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June D.O. PC
Lansing, Michigan 48910
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University of Nevada School of Medicine
Las Vegas, Nevada
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Steinberg Diagnostics
Las Vegas, Nevada 89109
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Access Health / Davis Group, Ltd.
Las Vegas, Nevada 89128
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Physician Research Collaboration
Lincoln, Nebraska 68512
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Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
Long Beach, California 90806
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ProHealth Partners
Long Beach, California 90808
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University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Los Angeles, California 90033
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Keck Medicine of USC
Los Angeles, California 90033
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
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Dr. Ramesh C. Gupta MD, Office of
6005 Park Avenue
Memphis, Tennessee 38119
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Center for Diagnostic Imaging
Mendota Heights, Minnesota 55118
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Southwest Rheumatology Research LLC
Mesquite, Texas 75150
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Mesquite, TX
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San Marcus Research Clinic
Miami, Florida 33015
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Doctors Research Institute
Miami, Florida 33145
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Center for Arthritis and Rheumatic Diseases
Miami, Florida 33173
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San Marcus Research Clinic
Miami Lakes, Florida 33014
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Trinity Health Center - Medical Arts
Minot, North Dakota 58701
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Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana 71203
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Nashua Rheumatology
Nashua, New Hampshire 03060
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Nashua Rheumatology, SNHHS
17 Prospect Street
Nashua, New Hampshire 03060
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