Methotrexate-Inadequate Response Study



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2008
End Date:September 2014

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A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept
yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in
participants with rheumatoid arthritis and an inadequate response to current methotrexate
therapy.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects who are considered methotrexate inadequate responders

- 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint
count)

Exclusion Criteria:

- Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies

- Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
erythematous)

- Subjects with active vasculitis of a major organ system (except for subcutaneous
rheumatoid nodules)

- Subjects with severe chronic or recurrent bacterial infections

- Subjects who have received treatment with rituximab

An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using
the same treatment as the Main study in order to assess the immunogenicity and safety in
the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and
participants were permitted to roll into the LT Open Label Period.
We found this trial at
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Boulder, Colorado 80304
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Albany, New York 12206
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Albuquerque, New Mexico
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Albuquerque, New Mexico 87102
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Arlington, VA
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Atlanta, Georgia 30342
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Austin, Texas 78705
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Bethlehem, Pennsylvania 18015
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Birmingham, Alabama 35205
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Bridgeport, Connecticut 06606
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Bridgeport, Connecticut 06606
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Charleston, South Carolina 29406
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Charlotte, North Carolina 28210
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Chesapeake, Virginia 23320
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Ciudad Autonoma, Buenos Aires
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Coeur D Alene, Idaho 83814
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Colorado Springs, Colorado 80910
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Columbia, South Carolina 29204
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Cumberland, Maryland 21502
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Danbury, Connecticut 06810
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Denver, Colorado 80230
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Dover, New Jersey 07801
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Durham, North Carolina 27704
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Eugene, Oregon 97401
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Greenville, North Carolina 27834
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Hot Springs, Arkansas 71913
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Huntington Beach, California 92646
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Jackson, Mississippi 39202
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Jackson, Tennessee 38305
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Knoxville, Tennessee 37909
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La Jolla, California 92037
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Lake Oswego, Oregon 97035
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Lee's Summit, Missouri 64086
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Lincoln, Nebraska 68512
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Loveland, Colorado 80538
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Memphis, Tennessee 38104
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Mobile, Alabama 36608
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Myrtle Beach, South Carolina 29572
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Nashville, Tennessee 37205
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Oklahoma City, Oklahoma 73103
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Orangeburg, South Carolina 29118
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Palm Harbor, Florida 34684
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Palo Alto, California 94304
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Providence, Rhode Island 02906
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Quincy, Illinois 62301
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Rockford, Illinois 61107
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San Diego, California 92108
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Scottsdale, Arizona 85258
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Springfield, Illinois 62704
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St. Clair Shores, Michigan 48081
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Statesville, North Carolina 28625
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Sugarland, Texas 77479
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Syracuse, New York 13210
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Tacoma, Washington 98405
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Tulsa, Oklahoma 74135
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Worcester, Massachusetts 01610
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