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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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
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Idaho Falls, Idaho 83404
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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Aventura, Florida 33180
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Baton Rouge, Louisiana 70809
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Baytown, Texas 77521
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Bridgeport, Connecticut 06606
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Charleston, South Carolina 29406
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Coeur D'Alene, Idaho 83814
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Covina, California 91723
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Duncansville, Pennsylvania 16635
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Edgewater, Florida 32132
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Fort Lauderdale, Florida 33334
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Frederick, Maryland 21702
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Gilbert, Arizona 85234
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Houston, Texas 77004
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Houston, Texas 77070
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Huntington Beach, California 92646
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Indianapolis, Indiana 46227
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Jackson, Tennessee 38305
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Kalamazoo, Michigan 49007
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Los Angeles, California 90033
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Mesquite, Texas 75150
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Minot, North Dakota 58701
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Monroe, Louisiana 71203
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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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Orlando, Florida 32804
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Palm Harbor, Florida 34684
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Philadelphia, Pennsylvania 19152
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Placentia, California 92870
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Plainview, New York 11803
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Salisbury, North Carolina 28144
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Salisbury, North Carolina 28144
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San Antonio, Texas 78229
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Spokane, Washington 99204
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Springfield, Missouri 65807
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Tampa, Florida 33614
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Van Nuys, California 91405
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Vernon Hills, Illinois 60061
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Vero Beach, Florida 32960
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Vero Beach, Florida 32960
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Whittier, California 90606
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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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Winter Garden, Florida 34787
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