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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Trial Summary
Trial Overview
Inclusion Criteria

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
71
sites
Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
Long Beach, California 90806
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Long Beach, CA
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The Center for Rheumatology, LLP
Albany, New York 12206
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Albany, NY
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Albuquerque Clinical Trials
Albuquerque, New Mexico
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Albuquerque, NM
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Albuquerque Rehabilitation & Rheumatology, PC
Albuquerque, New Mexico 87102
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Albuquerque, NM
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The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia 22205
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from
Arlington, VA
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Asheville Rheumatology & Osteoporosis Research Asso P. A.
Asheville, North Carolina 28801
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from
Asheville, NC
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Arthritis and Rheumatology of Georgia
Atlanta, Georgia 30342
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from
Atlanta, GA
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Walter F. Chase
Austin, Texas 78705
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Austin, TX
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Arthritis and Rheumatic Disease Specialties
Aventura, Florida 33180
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from
Aventura, FL
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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
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from
Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
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from
Birmingham, AL
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Boise Rheumatology/ Intermountain Research Center, Inc
Boise, Idaho 83702
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from
Boise, ID
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Boulder Medical Center
Boulder, Colorado 80304
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Boulder, CO
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Guadagnoli, Germano
Bridgeport, Connecticut 06606
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from
Bridgeport, CT
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Joao Nascimento, MD
Bridgeport, Connecticut 06606
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from
Bridgeport, CT
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Low Country Rheumatology
Charleston, South Carolina 29406
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from
Charleston, SC
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The Arthritis Clinic & Carolina Bone & Joint
Charlotte, North Carolina 28210
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from
Charlotte, NC
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Center for Arthritis and Rheumatic Diseases
Chesapeake, Virginia 23320
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from
Chesapeake, VA
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Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio 45219
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Cincinnati, OH
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Local Institution
Ciudad Autonoma, Buenos Aires
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from
Ciudad Autonoma,
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Coeur D'Alene Arthrit Clin
Coeur D Alene, Idaho 83814
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from
Coeur D Alene, ID
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Arthritis Assoc And Osteo Ctr Of Col Sprgs
Colorado Springs, Colorado 80910
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from
Colorado Springs, CO
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Columbia Arthritis Center, P.A.
Columbia, South Carolina 29204
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from
Columbia, SC
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Klein & Associates, MD, PA
Cumberland, Maryland 21502
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from
Cumberland, MD
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Clinical Research Center of CT/NY
Danbury, Connecticut 06810
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Danbury, CT
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Denver Arthritis Clinic
Denver, Colorado 80230
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Denver, CO
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Allergy And Arthritis Associates
Dover, New Jersey 07801
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from
Dover, NJ
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Rheumatology
Durham, North Carolina 27704
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Durham, NC
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Pro Research
Eugene, Oregon 97401
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from
Eugene, OR
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Physician's East
Greenville, North Carolina 27834
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from
Greenville, NC
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St. Joseph'S Mercy Clinic
Hot Springs, Arkansas 71913
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from
Hot Springs, AR
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Rheumatic Disease Clinical Research Center
Houston, Texas 77004
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from
Houston, TX
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Accurate Clinical Research
Houston, Texas
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Houston, TX
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Talbert Medical Group
Huntington Beach, California 92646
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from
Huntington Beach, CA
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Arthritis Assoicates Of Mississippi
Jackson, Mississippi 39202
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from
Jackson, MS
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The Arthritis Clinic
Jackson, Tennessee 38305
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Jackson, TN
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
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from
Knoxville, TN
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Allergy and Rheumatology Medical Clinic Inc
La Jolla, California 92037
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from
La Jolla, CA
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Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon 97035
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from
Lake Oswego, OR
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Kansas City Internal Medicine
Lee's Summit, Missouri 64086
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from
Lee's Summit, MO
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Physician Research Collaboration
Lincoln, Nebraska 68512
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from
Lincoln, NE
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Arthritis Center Of The Rockies, Pc
Loveland, Colorado 80538
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from
Loveland, CO
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The Arthritis Group, Pc
Memphis, Tennessee 38104
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from
Memphis, TN
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Coastal Clinical Research Inc
Mobile, Alabama 36608
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Mobile, AL
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Carolina Health Specialists
Myrtle Beach, South Carolina 29572
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Myrtle Beach, SC
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St. Thomas Hospital Tower East
Nashville, Tennessee 37205
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Nashville, TN
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
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from
Oklahoma City, OK
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Southern Tier Arthritis and Rheumatism
Olean, New York 14760
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from
Olean, NY
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South Puget Sound Clinincal Research Center
Olympia, Washington 98502
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from
Olympia, WA
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Arthritis & osteoporosis treatment center,PA
Orange Park, Florida 32073
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Orange Park, FL
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Acme Research L.L.C.
Orangeburg, South Carolina 29118
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Orangeburg, SC
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Rheumatology Associates of Central Florida
Orlando, Florida 32806
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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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Stanford University School of Medicine
Palo Alto, California 94304
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Palo Alto, CA
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Rheumatology Associates
Providence, Rhode Island 02906
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from
Providence, RI
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Quincy Medical Group
Quincy, Illinois 62301
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from
Quincy, IL
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Rockford Orthopedic Associates, LTD
Rockford, Illinois 61107
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from
Rockford, IL
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San Diego Arthritis Medical Clinic
San Diego, California 92108
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from
San Diego, CA
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Sarasota Arthritis Research Center
Sarasota, Florida 34239
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from
Sarasota, FL
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Advanced Arthritis Care and Research
Scottsdale, Arizona 85258
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from
Scottsdale, AZ
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The Arthritis Center
Springfield, Illinois 62704
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Springfield, IL
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Shores Rheumatology, P. C.
St. Clair Shores, Michigan 48081
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from
St. Clair Shores, MI
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Carolina Pharmaceutical Research
Statesville, North Carolina 28625
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from
Statesville, NC
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Texas Research Center
Sugarland, Texas 77479
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from
Sugarland, TX
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Arthritis Health Associates
Syracuse, New York 13210
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from
Syracuse, NY
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Tacoma Center for Arthritis Research, PS
Tacoma, Washington 98405
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from
Tacoma, WA
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Catalina Pointe Clinical Research
Tucson, Arizona 85704
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from
Tucson, AZ
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Oklahoma Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma 74104
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from
Tulsa, OK
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Healthcare Research Consultants
Tulsa, Oklahoma 74135
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Tulsa, OK
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Carolina Arthritis Associates
Wilmington, North Carolina 28401
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from
Wilmington, NC
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Clinical Pharmacology Study Group
Worcester, Massachusetts 01610
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from
Worcester, MA
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