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
Medvin Clinical Research
Covina, California 91723
1952
mi
from 43215
Covina, CA
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
673
mi
from 43215
Jacksonville, FL
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AARDS Research, Inc
Aventura, Florida 33180
982
mi
from 43215
Aventura, FL
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Arthritis and Rheumatic Disease Specialties
Aventura, Florida 33180
981
mi
from 43215
Aventura, FL
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Ochsner Clinic - Baton Rouge
Baton Rouge, Louisiana 70809
802
mi
from 43215
Baton Rouge, LA
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Accurate Clinical Management, LLC
Baytown, Texas 77521
972
mi
from 43215
Baytown, TX
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Joao M. A. Nascimento
Bridgeport, Connecticut 06606
?
mi
from 43215
Bridgeport, CT
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Atencion Integral en Reumatologia (AIR)
Caba, Buenos Aires
5386
mi
from 43215
Caba,
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Low Country Rheumatology
Charleston, South Carolina 29406
525
mi
from 43215
Charleston, SC
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
1748
mi
from 43215
Coeur D'Alene, ID
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
911
mi
from 43215
Dallas, TX
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Metroplex Clinical Research Center
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
244
mi
from 43215
Duncansville, PA
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Riverside Clinical Research
Edgewater, Florida 32132
767
mi
from 43215
Edgewater, FL
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Arthritis and Osteoporosis Treatment and Research Center
Flowood, Mississippi 39232
660
mi
from 43215
Flowood, MS
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Centre for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida 33334
966
mi
from 43215
Fort Lauderdale, FL
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Arthritis Treatment Center
Frederick, Maryland 21702
300
mi
from 43215
Frederick, MD
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St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California 92835
1959
mi
from 43215
Fullerton, CA
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ArthroCare, Arthritis Care Research
Gilbert, Arizona 85234
1648
mi
from 43215
Gilbert, AZ
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Accurate Clinical Management
Houston, Texas 77004
993
mi
from 43215
Houston, TX
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Rheumatology Clinic of Houston
Houston, Texas 77070
988
mi
from 43215
Houston, TX
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Houston Institute for Clinical Research
Houston, Texas 77024
996
mi
from 43215
Houston, TX
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HealthCare Partners Medical Group
Huntington Beach, California 92646
1969
mi
from 43215
Huntington Beach, CA
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
411
mi
from 43215
Huntsville, AL
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Institute of Arthritis Research
Idaho Falls, Idaho 83404
1506
mi
from 43215
Idaho Falls, ID
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
166
mi
from 43215
Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
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Jasper Clinic, Inc.
Kalamazoo, Michigan 49007
209
mi
from 43215
Kalamazoo, MI
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Keck Medicine of USC - Division of Rheumatology
Los Angeles, California 90033
1970
mi
from 43215
Los Angeles, CA
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University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Los Angeles, California 90033
1970
mi
from 43215
Los Angeles, CA
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Ronald Reagan UCLA Medical Center - Drug Information Center
Los Angeles, California 90095
1982
mi
from 43215
Los Angeles, CA
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UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California 90095
1982
mi
from 43215
Los Angeles, CA
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
1134
mi
from 43215
Lubbock, TX
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Southwest Rheumatology Research LLC
Mesquite, Texas 75150
901
mi
from 43215
Mesquite, TX
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Trinity Health Center - Medical Arts
Minot, North Dakota 58701
1067
mi
from 43215
Minot, ND
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Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana 71203
717
mi
from 43215
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...
849
mi
from 43215
Oklahoma City, OK
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Omega Research Consultants, Llc
Orlando, Florida 32804
792
mi
from 43215
Orlando, FL
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The Arthritis Center
Palm Harbor, Florida 34684
821
mi
from 43215
Palm Harbor, FL
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Gulf Region Clinical Research Institute Llc
Pensacola, Florida 32514
700
mi
from 43215
Pensacola, FL
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Arthritis Group
Philadelphia, Pennsylvania 19152
416
mi
from 43215
Philadelphia, PA
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Medvin Clinical Research
Placentia, California 92870
1957
mi
from 43215
Placentia, CA
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Dr. Prem C. Chatpar M.D.,LLC
Plainview, New York 11803
505
mi
from 43215
Plainview, NY
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St. Louis Center For Clinical Research Barbara Caciolo, MD
Saint Louis, Missouri 63128
?
mi
from 43215
Saint Louis, MO
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Pmg Research Of Salisbury
Salisbury, North Carolina 28144
328
mi
from 43215
Salisbury, NC
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Rowan Diagnostic Clinic, PA
Salisbury, North Carolina 28144
327
mi
from 43215
Salisbury, NC
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Accurate Clinical Research, Inc.
San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
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Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas 78232
1128
mi
from 43215
San Antonio, TX
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San Diego Arthritis Medical Clinic
San Diego, California 92108
1951
mi
from 43215
San Diego, CA
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Arthritis Northwest
Spokane, Washington 99204
1779
mi
from 43215
Spokane, WA
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Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri 65807
585
mi
from 43215
Springfield, MO
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West Broward Rheumatology Associates, Inc.
Tamarac, Florida 33321
963
mi
from 43215
Tamarac, FL
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BayCare Medical Group, Inc.
Tampa, Florida 33614
830
mi
from 43215
Tampa, FL
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Inland Rheumatology Clinical Trials, Inc.
Upland, California 91786
1939
mi
from 43215
Upland, CA
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Medvin Clinical Research
Van Nuys, California 91405
1979
mi
from 43215
Van Nuys, CA
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Deerbrook Medical Associates
Vernon Hills, Illinois 60061
301
mi
from 43215
Vernon Hills, IL
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The Center for Arthritis and Rheumatism
Vero Beach, Florida 32960
864
mi
from 43215
Vero Beach, FL
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The Office of Alastair C. Kennedy, MD
Vero Beach, Florida 32960
864
mi
from 43215
Vero Beach, FL
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Medvin Clinical Research
Whittier, California 90606
1965
mi
from 43215
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...
484
mi
from 43215
Wilmington, NC
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Advanced Clinical Research of Orlando, Inc.
Winter Garden, Florida 34787
791
mi
from 43215
Winter Garden, FL
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