Phase
Condition
Rheumatoid Arthritis
Dermatomyositis (Connective Tissue Disease)
Musculoskeletal Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body weight
Active moderate to severe rheumatoid arthritis (DAS28 >/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1)
Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of atleast 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the followingexception: a stable dose of at least 10 mg/week is allowed for participants with abody weight <50 kg or calculated glomerular filtration rate (or creatinine clearance) <60 milliliters per minute (mL/min)
History of parenteral (SC or intramuscular [IM]) MTX is allowed, but not within 6weeks prior to treatment (Day 1). Participants must not have a documented, clinicallysignificant intolerance to oral MTX and must be receiving oral MTX at a dose of 15mg/week for at least 6 weeks prior to treatment (Day 1)
Participants who have received one prior anti-tumor necrosis factor (TNF) must havediscontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for atleast 6 months prior to screening
Oral corticosteroids must have been
Participants receiving treatment on an outpatient basis
Exclusion
Exclusion Criteria:
Documented medical history of significant intolerance to oral MTX >/=15 mg/week
Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs)within 8 weeks of screening
Previous treatment with abatacept, rituximab, tofacitinib, or anakinra
Treatment with parenteral corticosteroids within 4 weeks prior to treatment
Previous treatment with cell-depleting therapies or alkylating agents
Previous treatment with TCZ
Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery during the study
Rheumatic autoimmune disease other than rheumatoid arthritis
Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases,psoriasis, multiple sclerosis)
Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Functional Class IV according to the revised (1987) ACR criteria for rheumatoidarthritis
History of severe allergic or anaphylactic reactions to human, humanized, or murinemonoclonal antibodies
Evidence of significant uncontrolled concomitant diseases; uncontrolled disease stateswhere flares are commonly treated with oral or parenteral corticosteroids
Active current or history of recurrent infection, or any major episode of infectionrequiring hospitalization or treatment with intravenous antibiotics within 4 weeksprior to screening or oral antibiotics within 2 weeks prior to screening
Active tuberculosis requiring treatment within the previous 3 years
History of or currently active primary or secondary immunodeficiency
Pregnant or breast-feeding women
Positive for hepatitis B or hepatitis C infection
For potential MRI substudy participants: the presence of any metal-containing deviceor object in the body
Study Design
Connect with a study center
Pinnacle Research Group; Llc, Central
Anniston, Alabama 36207
United StatesSite Not Available
Uni Of Alabama,Birmingham; Medicine - Rheumatology
Birmingham, Alabama 35294
United StatesSite Not Available
Rheumatology Associates of North Alabama
Huntsville, Alabama 35801
United StatesSite Not Available
Clnical & Translational Reseach Center for Alabama, PC
Tuscaloosa, Alabama 35406
United StatesSite Not Available
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona 85306
United StatesSite Not Available
Arizona Arthritis & Rheumatology Research, Pllc
Mesa, Arizona 85202
United StatesSite Not Available
Arizona Arthritis and Rheuma
Mesa, Arizona 85202
United StatesSite Not Available
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Paradise Valley, Arizona 85253
United StatesSite Not Available
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Peoria, Arizona 85381
United StatesSite Not Available
Valley Arthritis Care
Phoenix, Arizona 85027
United StatesSite Not Available
Advanced Arthritis Care & Research
Scottsdale, Arizona 85258
United StatesSite Not Available
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Tucson, Arizona 85712
United StatesSite Not Available
Fort Smith Rheumatology, PC
Fort Smith, Arkansas 72903
United StatesSite Not Available
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
United StatesSite Not Available
NEA Baptist Clinic
Jonesboro, Arkansas 72401
United StatesSite Not Available
Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
United StatesSite Not Available
Medvin Clinical Research
Covina, California 91723
United StatesSite Not Available
TriWest Research Associates, LLC
El Cajon, California 92020
United StatesSite Not Available
St. Jude Hospital Yorba Linda DBA St. Joseph
Fullerton, California 92835
United StatesSite Not Available
CV Mehta MD Medical Corp
Hemet, California 92543
United StatesSite Not Available
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Long Beach, California 90806
United StatesSite Not Available
Valerius Medical Group
Los Alamitos, California 90720
United StatesSite Not Available
NRC Research Institute
Orange, California 92868
United StatesSite Not Available
San Diego Arthritis Med Clnc
San Diego, California 92108
United StatesSite Not Available
C Michael Neuwelt MD Inc
San Leandro, California 94578
United StatesSite Not Available
Inland Rheumatology; Clinical Trials, Inc.
Upland, California 91785-1141
United StatesSite Not Available
Medvin Clinical Research
Whittier, California 90606
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado 80920
United StatesSite Not Available
Denver Arthritis Clinic
Denver, Colorado 80230-7127
United StatesSite Not Available
Joao Nascimento
Bridgeport, Connecticut 06606
United StatesSite Not Available
Clinical Research Center of Ct/Ny
Danbury, Connecticut 06810
United StatesSite Not Available
Arthritis & Osteoporosis Center Pc
Hamden, Connecticut 06518
United StatesSite Not Available
New England Research Associates
Trumbull, Connecticut 06611
United StatesSite Not Available
Rheumatolgy Consultants of Deleware
Lewes, Delaware 19958
United StatesSite Not Available
Javed Rheumatology Associates, Inc.
Newark, Delaware 19713
United StatesSite Not Available
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida 33180
United StatesSite Not Available
Robert Levin, Md; Research Dept
Dunedin, Florida 34698
United StatesSite Not Available
South Coast Research Center, Inc.
Miami, Florida 33136
United StatesSite Not Available
Suncoast Research Group LLC
Miami, Florida 33135
United StatesSite Not Available
Precision Research Organization
Miami Lakes, Florida 33016
United StatesSite Not Available
Jeffrey Alper M.D Research
Naples, Florida 34102
United StatesSite Not Available
Arthritis and Rheumatology Clinic
Orlando, Florida 32836
United StatesSite Not Available
Rheumatology Associates of Central Florida
Orlando, Florida 32806
United StatesSite Not Available
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Palm Habor, Florida 34684
United StatesSite Not Available
Arthritis Center Palm Harbor
Palm Harbor, Florida 34684
United StatesSite Not Available
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida 34684
United StatesSite Not Available
Pinellas Medical Research - Allegry & Rheumatology Associates, LLC
Saint Petersburg, Florida 33708
United StatesSite Not Available
Sarasota Arthritis Res Center
Sarasota, Florida 34239
United StatesSite Not Available
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St. Petersburg, Florida 33708
United StatesSite Not Available
West Broward Rheumatology Associates, Inc.
Tamarac, Florida 33321
United StatesSite Not Available
Burnette & Silverfield, MDS
Tampa, Florida 33614
United StatesSite Not Available
McIlwain Medical Group
Tampa, Florida 33613
United StatesSite Not Available
Advanced Clinical Research of Orlando, Inc.
Winter Garden, Florida 34787
United StatesSite Not Available
North Georgia Rheumatology
Duluth, Georgia 30096
United StatesSite Not Available
Arthritis Center of North Georgia
Gainesville, Georgia 30501
United StatesSite Not Available
North Georgia Rheumatology Group, PC
Lawrenceville, Georgia 30046
United StatesSite Not Available
Institute of Arthritis Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Springfield Clinic
Springfield, Illinois 62703
United StatesSite Not Available
Diagnostic Rheumatology & Research
Indianapolis, Indiana 46227
United StatesSite Not Available
Indiana Uni Medical Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Kansas City Internal Medicine
Overland Park, Kansas 66209
United StatesSite Not Available
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Wichita, Kansas 67208
United StatesSite Not Available
Bluegrass Comm Research, Inc.
Lexington, Kentucky 40515
United StatesSite Not Available
Arthritis & Diabetes Clinic, Inc
Monroe, Louisiana 71203
United StatesSite Not Available
Klein & Associates, M.D., P.A.
Hagerstown, Maryland 21740
United StatesSite Not Available
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Wheaton, Maryland 20902
United StatesSite Not Available
New England Medical Center; Dept. of Medicine, Div. of Rheumatology
Boston, Massachusetts 02111
United StatesSite Not Available
Phase Iii Clinical Research
Fall River, Massachusetts 02720
United StatesSite Not Available
Mansfield Medical Center
Mansfield, Massachusetts 02048
United StatesSite Not Available
Clinical Pharmacology Study Group
Worcester, Massachusetts 01610
United StatesSite Not Available
Reliant Medical Group, Inc; Rheumatology
Worcester, Massachusetts 01605
United StatesSite Not Available
UMass Memorial Medical Center
Worcester, Massachusetts 01605
United StatesSite Not Available
Advanced Rheumatology, PC
Lansing, Michigan 48910
United StatesSite Not Available
Fiechtner Research Inc
Lansing, Michigan 48910
United StatesSite Not Available
Nisus Research/Northern Michigan Hospital
Petoskey, Michigan 49770
United StatesSite Not Available
Shores Rheumatology
Saint Clair Shores, Michigan 48081
United StatesSite Not Available
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St. Claire Shores, Michigan 48081
United StatesSite Not Available
St. Luke's Hospital Association of Duluth
Duluth, Minnesota 55805
United StatesSite Not Available
St. Paul Rheumatology
Eagan, Minnesota 55121
United StatesSite Not Available
Arthritis and Osteoporosis; Treatment and Research Center
Flowood, Mississippi 39232
United StatesSite Not Available
Jackson Arthritis Clinic
Flowood, Mississippi 39232
United StatesSite Not Available
David S Rosenberg
Florissant, Missouri 63031
United StatesSite Not Available
Clinical Research Consultants,LLC
Kansas City, Missouri 64111
United StatesSite Not Available
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Lee's Summit, Missouri 64086
United StatesSite Not Available
Arthritis Consultants
Saint Louis, Missouri 63141
United StatesSite Not Available
Clayton Medical Research
Saint Louis, Missouri 63117
United StatesSite Not Available
G. T. Kelly, MD
Las Vegas, Nevada 89128
United StatesSite Not Available
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Lebabon, New Hampshire 03756
United StatesSite Not Available
Rheumatology Research Group
Lebanon, New Hampshire 03756
United StatesSite Not Available
Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire 03060
United StatesSite Not Available
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Clifton, New Jersey 07012
United StatesSite Not Available
Arthritis and Osteoporosis Associates
Manalapan, New Jersey 07726
United StatesSite Not Available
Atlantic Coast Rheumatology
Toms River, New Jersey 08755
United StatesSite Not Available
Ocean Rheumatology
Toms River, New Jersey 08775
United StatesSite Not Available
Arthritis Rheumatic & Back Disease Associates
Voorhees, New Jersey 08043
United StatesSite Not Available
Cooper Cancer Institute
Voorhees, New Jersey 08043
United StatesSite Not Available
Albuquerque Clinical Trials
Albuquerque, New Mexico 87102
United StatesSite Not Available
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico 88011
United StatesSite Not Available
The Center for Rheumatology
Albany, New York 12203
United StatesSite Not Available
Arthritis & Osteoporosis Center
Brooklyn, New York 11201
United StatesSite Not Available
Manhasset Rheumatology
Manhasset, New York 11030
United StatesSite Not Available
Manhattan Medical Reserach
New York, New York 10016
United StatesSite Not Available
Buffalo Rheumatology Associates
Orchard Park, New York 14127
United StatesSite Not Available
Office of Premier Chatpar Md
Plainview, New York 11803
United StatesSite Not Available
Rheumatology Associates of Long Island
Smithtown, New York 11787
United StatesSite Not Available
Arthritis Health Associates
Syracuse, New York 13210
United StatesSite Not Available
Asheville Arthritis & Osteoporosis Center, PA
Asheville, North Carolina 28803
United StatesSite Not Available
Carolina Bone & Joint P.A.
Charlotte, North Carolina 28210
United StatesSite Not Available
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Delco, North Carolina 28436
United StatesSite Not Available
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina 27704
United StatesSite Not Available
Medication Management
Greensboro, North Carolina 27408
United StatesSite Not Available
PMG Research of Hickory LLC
Hickory, North Carolina 28602
United StatesSite Not Available
Cape Fear Arthritis Care
Leland, North Carolina 28451
United StatesSite Not Available
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina 27617
United StatesSite Not Available
Odyssey Research Services; Main Medical Building
Bismarck, North Dakota 58507
United StatesSite Not Available
St. Alexius Medical Center; Arthritis Clinic
Bismarck, North Dakota 58501
United StatesSite Not Available
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Bismark, North Dakota 58507
United StatesSite Not Available
Crystal Arthritis Center, Inc.
Akron, Ohio 44333
United StatesSite Not Available
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio 45219
United StatesSite Not Available
University Hospitals Case Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
Columbus Arthritis Center
Columbus, Ohio 43215
United StatesSite Not Available
Ohio State University; Rheumatology; Immun/Rheum
Columbus, Ohio 43203
United StatesSite Not Available
STAT Research Inc
Dayton, Ohio 45417
United StatesSite Not Available
Paramount Medical Research
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Clinical Research Source, Inc.
Toledo, Ohio 43606
United StatesSite Not Available
Arthritis Care Center Oklahoma
Ardmore, Oklahoma 73401
United StatesSite Not Available
Arthritis and Rheumatology; Center of Oklahoma PLLC
Oklahoma City, Oklahoma 73103
United StatesSite Not Available
Health Research of Oklahoma, Llc
Oklahoma City, Oklahoma 73103
United StatesSite Not Available
Lynn Health Science Inst.
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Healthcare Research Consultants
Tulsa, Oklahoma 74135
United StatesSite Not Available
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma 74104
United StatesSite Not Available
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Portland, Oregon 97225
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Arthritis Associates
Erie, Pennsylvania 16508
United StatesSite Not Available
Arthritis Group
Philadelphia, Pennsylvania 19152
United StatesSite Not Available
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Pittsburgh, Pennsylvania 15237
United StatesSite Not Available
Advanced Rheumatology & Arthritis Research Center
Wexford, Pennsylvania 15090
United StatesSite Not Available
Clinical Research Center of Reading
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Emkey Arthritis & Osteoporosis
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Low Country Rheumatology, PA
Charleston, South Carolina 29406
United StatesSite Not Available
Columbia Arthritis Center (Partnership Practice)
Columbia, South Carolina 29204
United StatesSite Not Available
Piedmont Arthritis Clinic
Greenville, South Carolina 29601
United StatesSite Not Available
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
Ramesh Gupta - PP
Memphis, Tennessee 38119
United StatesSite Not Available
Amarillo Center For Clinical Research
Amarillo, Texas 79124
United StatesSite Not Available
Austin Regional Clinic
Austin, Texas 78731
United StatesSite Not Available
Lovelace Scientific Resources Inc.
Austin, Texas 78758
United StatesSite Not Available
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Baytown, Texas 77521
United StatesSite Not Available
Diagnostic Group
Beaumont, Texas 77701
United StatesSite Not Available
AOCBV
College Station, Texas 77845
United StatesSite Not Available
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas 78404
United StatesSite Not Available
Arthritis Care & Diagnostic Center
Dallas, Texas 75231-4406
United StatesSite Not Available
Metroplex Clinical Research
Dallas, Texas 75231
United StatesSite Not Available
Accurate Clinical Research
Houston, Texas 77089
United StatesSite Not Available
Houston Inst. For Clinical Research
Houston, Texas 77074
United StatesSite Not Available
IntraFusion Researh Network
Houston, Texas 77007
United StatesSite Not Available
Rheumatic Disease Clin Res Ctr
Houston, Texas 77004
United StatesSite Not Available
Southwest Rheumatology
Mesquite, Texas 75150
United StatesSite Not Available
Accurate Clinical Management
San Antonio, Texas 78229
United StatesSite Not Available
Arthiritis & Osteoporosis Centre of South Texas
San Antonio, Texas 78232
United StatesSite Not Available
NextGen Clinical Research Inc
San Antonio, Texas 78229
United StatesSite Not Available
Arthritis Clinic Of Central Texas
San Marcos, Texas 78666
United StatesSite Not Available
Crossroads Clinical Research, LLC
Victoria, Texas 77901
United StatesSite Not Available
Arthritis & Osteoporosis Clinic
Waco, Texas 76710
United StatesSite Not Available
South Puget Sound Clinical Research
Olympia, Washington 98502
United StatesSite Not Available
Arthritis Northwest, Spokane
Spokane, Washington 99204
United StatesSite Not Available
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington 98801
United StatesSite Not Available
Mountain State Clinical Research
Clarksburg, West Virginia 26301
United StatesSite Not Available
Rheumatic Disease Center
Glendale, Wisconsin 53217
United StatesSite Not Available
Lakeshore Orthopedics
Manitowoc, Wisconsin 54220
United StatesSite Not Available
Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
Onalaska, Wisconsin 54605
United StatesSite Not Available
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