An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate



Status:Completed
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:6/29/2018
Start Date:August 2014
End Date:December 2016

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as
compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy
compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes
measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.
To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or
adalimumab.


Inclusion Criteria:

- Have moderate to severe rheumatoid arthritis

- On methotrexate but inadequately controlled

- Subjects must not have active tuberculosis or an inadequately treated tuberculosis
infection

- Subjects must use contraception

Exclusion Criteria:

- Subjects who have been previously treated with adalimumab or Tofacitinib

- Subjects with any current malignancy or a history of malignancy, with the exception of
adequately treated or excised non metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

- Subjects with specific laboratory test abnormalities

- Subjects with specific types of infections
We found this trial at
61
sites
West Broward Rheumatology Associates, Inc.
Tamarac, Florida 33321
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Tamarac, FL
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
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Jacksonville, FL
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AARDS Research, Inc
Aventura, Florida 33180
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Aventura, FL
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Arthritis and Rheumatic Disease Specialties
Aventura, Florida 33180
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Aventura, FL
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Ochsner Clinic - Baton Rouge
Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Accurate Clinical Management, LLC
Baytown, Texas 77521
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Baytown, TX
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Joao M. A. Nascimento
Bridgeport, Connecticut 06606
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Bridgeport, CT
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Atencion Integral en Reumatologia (AIR)
Caba, Buenos Aires
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Caba,
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Low Country Rheumatology
Charleston, South Carolina 29406
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Charleston, SC
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
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Coeur D'Alene, ID
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Medvin Clinical Research
Covina, California 91723
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Covina, CA
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
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Dallas, TX
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Metroplex Clinical Research Center
Dallas, Texas 75231
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Dallas, TX
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Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
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Duncansville, PA
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Riverside Clinical Research
Edgewater, Florida 32132
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Edgewater, FL
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Arthritis and Osteoporosis Treatment and Research Center
Flowood, Mississippi 39232
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Flowood, MS
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Centre for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida 33334
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Fort Lauderdale, FL
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Arthritis Treatment Center
Frederick, Maryland 21702
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Frederick, MD
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St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California 92835
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Fullerton, CA
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ArthroCare, Arthritis Care Research
Gilbert, Arizona 85234
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Gilbert, AZ
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Accurate Clinical Management
Houston, Texas 77004
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Houston, TX
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Rheumatology Clinic of Houston
Houston, Texas 77070
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Houston, TX
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Houston Institute for Clinical Research
Houston, Texas 77024
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Houston, TX
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HealthCare Partners Medical Group
Huntington Beach, California 92646
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Huntington Beach, CA
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
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Huntsville, AL
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Institute of Arthritis Research
Idaho Falls, Idaho 83404
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Idaho Falls, ID
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
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Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
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Jackson, TN
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Jasper Clinic, Inc.
Kalamazoo, Michigan 49007
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Kalamazoo, MI
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Keck Medicine of USC - Division of Rheumatology
Los Angeles, California 90033
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Los Angeles, CA
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University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Los Angeles, California 90033
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Los Angeles, CA
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Ronald Reagan UCLA Medical Center - Drug Information Center
Los Angeles, California 90095
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Los Angeles, CA
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UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California 90095
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Los Angeles, CA
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
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Lubbock, TX
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Southwest Rheumatology Research LLC
Mesquite, Texas 75150
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Mesquite, TX
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Trinity Health Center - Medical Arts
Minot, North Dakota 58701
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Minot, ND
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Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana 71203
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Monroe, LA
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Lynn Health Science Institute
3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, OK
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Omega Research Consultants, Llc
Orlando, Florida 32804
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Orlando, FL
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The Arthritis Center
Palm Harbor, Florida 34684
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Palm Harbor, FL
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Gulf Region Clinical Research Institute Llc
Pensacola, Florida 32514
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Pensacola, FL
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Arthritis Group
Philadelphia, Pennsylvania 19152
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Philadelphia, PA
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Medvin Clinical Research
Placentia, California 92870
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Placentia, CA
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Dr. Prem C. Chatpar M.D.,LLC
Plainview, New York 11803
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Plainview, NY
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St. Louis Center For Clinical Research Barbara Caciolo, MD
Saint Louis, Missouri 63128
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Saint Louis, MO
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Pmg Research Of Salisbury
Salisbury, North Carolina 28144
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Salisbury, NC
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Rowan Diagnostic Clinic, PA
Salisbury, North Carolina 28144
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Salisbury, NC
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Accurate Clinical Research, Inc.
San Antonio, Texas 78229
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San Antonio, TX
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Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas 78232
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San Antonio, TX
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San Diego Arthritis Medical Clinic
San Diego, California 92108
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San Diego, CA
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Arthritis Northwest
Spokane, Washington 99204
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Spokane, WA
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Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri 65807
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Springfield, MO
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BayCare Medical Group, Inc.
Tampa, Florida 33614
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Tampa, FL
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Inland Rheumatology Clinical Trials, Inc.
Upland, California 91786
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Upland, CA
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Medvin Clinical Research
Van Nuys, California 91405
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Van Nuys, CA
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Deerbrook Medical Associates
Vernon Hills, Illinois 60061
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Vernon Hills, IL
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The Center for Arthritis and Rheumatism
Vero Beach, Florida 32960
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Vero Beach, FL
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The Office of Alastair C. Kennedy, MD
Vero Beach, Florida 32960
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Vero Beach, FL
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Medvin Clinical Research
Whittier, California 90606
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Whittier, CA
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PMG Research of Wilmington
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Advanced Clinical Research of Orlando, Inc.
Winter Garden, Florida 34787
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Winter Garden, FL
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