A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX

Last updated: November 30, 2017
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT01855789
ML28776
  • Ages > 18
  • All Genders

Study Summary

This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (

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

Total Participants: 718
Study Start date:
November 07, 2013
Estimated Completion Date:
October 14, 2016

Connect with a study center

  • Pinnacle Research Group; Llc, Central

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Uni Of Alabama,Birmingham; Medicine - Rheumatology

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Clnical & Translational Reseach Center for Alabama, PC

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, Pllc

    Mesa, Arizona 85202
    United States

    Site Not Available

  • Arizona Arthritis and Rheuma

    Mesa, Arizona 85202
    United States

    Site Not Available

  • empty

    Paradise Valley, Arizona 85253
    United States

    Site Not Available

  • empty

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Valley Arthritis Care

    Phoenix, Arizona 85027
    United States

    Site Not Available

  • Advanced Arthritis Care & Research

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • empty

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Fort Smith Rheumatology, PC

    Fort Smith, Arkansas 72903
    United States

    Site Not Available

  • CHI St. Vincent Medical Group Hot Springs

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • NEA Baptist Clinic

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Medvin Clinical Research

    Covina, California 91723
    United States

    Site Not Available

  • TriWest Research Associates, LLC

    El Cajon, California 92020
    United States

    Site Not Available

  • St. Jude Hospital Yorba Linda DBA St. Joseph

    Fullerton, California 92835
    United States

    Site Not Available

  • CV Mehta MD Medical Corp

    Hemet, California 92543
    United States

    Site Not Available

  • empty

    Long Beach, California 90806
    United States

    Site Not Available

  • Valerius Medical Group

    Los Alamitos, California 90720
    United States

    Site Not Available

  • NRC Research Institute

    Orange, California 92868
    United States

    Site Not Available

  • San Diego Arthritis Med Clnc

    San Diego, California 92108
    United States

    Site Not Available

  • C Michael Neuwelt MD Inc

    San Leandro, California 94578
    United States

    Site Not Available

  • Inland Rheumatology; Clinical Trials, Inc.

    Upland, California 91785-1141
    United States

    Site Not Available

  • Medvin Clinical Research

    Whittier, California 90606
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

    Colorado Springs, Colorado 80920
    United States

    Site Not Available

  • Denver Arthritis Clinic

    Denver, Colorado 80230-7127
    United States

    Site Not Available

  • Joao Nascimento

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Clinical Research Center of Ct/Ny

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Arthritis & Osteoporosis Center Pc

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • New England Research Associates

    Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Rheumatolgy Consultants of Deleware

    Lewes, Delaware 19958
    United States

    Site Not Available

  • Javed Rheumatology Associates, Inc.

    Newark, Delaware 19713
    United States

    Site Not Available

  • Arthritis & Rheumatism; Disease Specialities

    Aventura, Florida 33180
    United States

    Site Not Available

  • Robert Levin, Md; Research Dept

    Dunedin, Florida 34698
    United States

    Site Not Available

  • South Coast Research Center, Inc.

    Miami, Florida 33136
    United States

    Site Not Available

  • Suncoast Research Group LLC

    Miami, Florida 33135
    United States

    Site Not Available

  • Precision Research Organization

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Jeffrey Alper M.D Research

    Naples, Florida 34102
    United States

    Site Not Available

  • Arthritis and Rheumatology Clinic

    Orlando, Florida 32836
    United States

    Site Not Available

  • Rheumatology Associates of Central Florida

    Orlando, Florida 32806
    United States

    Site Not Available

  • empty

    Palm Habor, Florida 34684
    United States

    Site Not Available

  • Arthritis Center Palm Harbor

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Arthritis Rsrch of Florida, Inc.

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Pinellas Medical Research - Allegry & Rheumatology Associates, LLC

    Saint Petersburg, Florida 33708
    United States

    Site Not Available

  • Sarasota Arthritis Res Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • empty

    St. Petersburg, Florida 33708
    United States

    Site Not Available

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Burnette & Silverfield, MDS

    Tampa, Florida 33614
    United States

    Site Not Available

  • McIlwain Medical Group

    Tampa, Florida 33613
    United States

    Site Not Available

  • Advanced Clinical Research of Orlando, Inc.

    Winter Garden, Florida 34787
    United States

    Site Not Available

  • North Georgia Rheumatology

    Duluth, Georgia 30096
    United States

    Site Not Available

  • Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Institute of Arthritis Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois 62703
    United States

    Site Not Available

  • Diagnostic Rheumatology & Research

    Indianapolis, Indiana 46227
    United States

    Site Not Available

  • Indiana Uni Medical Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Kansas City Internal Medicine

    Overland Park, Kansas 66209
    United States

    Site Not Available

  • empty

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Bluegrass Comm Research, Inc.

    Lexington, Kentucky 40515
    United States

    Site Not Available

  • Arthritis & Diabetes Clinic, Inc

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • empty

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • New England Medical Center; Dept. of Medicine, Div. of Rheumatology

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Phase Iii Clinical Research

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • Mansfield Medical Center

    Mansfield, Massachusetts 02048
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01610
    United States

    Site Not Available

  • Reliant Medical Group, Inc; Rheumatology

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Advanced Rheumatology, PC

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Fiechtner Research Inc

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Nisus Research/Northern Michigan Hospital

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • Shores Rheumatology

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • empty

    St. Claire Shores, Michigan 48081
    United States

    Site Not Available

  • St. Luke's Hospital Association of Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • St. Paul Rheumatology

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • Arthritis and Osteoporosis; Treatment and Research Center

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Jackson Arthritis Clinic

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • David S Rosenberg

    Florissant, Missouri 63031
    United States

    Site Not Available

  • Clinical Research Consultants,LLC

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • empty

    Lee's Summit, Missouri 64086
    United States

    Site Not Available

  • Arthritis Consultants

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Clayton Medical Research

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • G. T. Kelly, MD

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • empty

    Lebabon, New Hampshire 03756
    United States

    Site Not Available

  • Rheumatology Research Group

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Nashua Rheumatology - Foundation Medical Partners

    Nashua, New Hampshire 03060
    United States

    Site Not Available

  • empty

    Clifton, New Jersey 07012
    United States

    Site Not Available

  • Arthritis and Osteoporosis Associates

    Manalapan, New Jersey 07726
    United States

    Site Not Available

  • Atlantic Coast Rheumatology

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Ocean Rheumatology

    Toms River, New Jersey 08775
    United States

    Site Not Available

  • Arthritis Rheumatic & Back Disease Associates

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Cooper Cancer Institute

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico 88011
    United States

    Site Not Available

  • The Center for Rheumatology

    Albany, New York 12203
    United States

    Site Not Available

  • Arthritis & Osteoporosis Center

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Manhasset Rheumatology

    Manhasset, New York 11030
    United States

    Site Not Available

  • Manhattan Medical Reserach

    New York, New York 10016
    United States

    Site Not Available

  • Buffalo Rheumatology Associates

    Orchard Park, New York 14127
    United States

    Site Not Available

  • Office of Premier Chatpar Md

    Plainview, New York 11803
    United States

    Site Not Available

  • Rheumatology Associates of Long Island

    Smithtown, New York 11787
    United States

    Site Not Available

  • Arthritis Health Associates

    Syracuse, New York 13210
    United States

    Site Not Available

  • Asheville Arthritis & Osteoporosis Center, PA

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Carolina Bone & Joint P.A.

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • empty

    Delco, North Carolina 28436
    United States

    Site Not Available

  • Triangle Orthopaedics Associates, P.A.

    Durham, North Carolina 27704
    United States

    Site Not Available

  • Medication Management

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PMG Research of Hickory LLC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Cape Fear Arthritis Care

    Leland, North Carolina 28451
    United States

    Site Not Available

  • Shanahan Rheumatology & Immunology, PLLC

    Raleigh, North Carolina 27617
    United States

    Site Not Available

  • Odyssey Research Services; Main Medical Building

    Bismarck, North Dakota 58507
    United States

    Site Not Available

  • St. Alexius Medical Center; Arthritis Clinic

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • empty

    Bismark, North Dakota 58507
    United States

    Site Not Available

  • Crystal Arthritis Center, Inc.

    Akron, Ohio 44333
    United States

    Site Not Available

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Columbus Arthritis Center

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Ohio State University; Rheumatology; Immun/Rheum

    Columbus, Ohio 43203
    United States

    Site Not Available

  • STAT Research Inc

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Paramount Medical Research

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Clinical Research Source, Inc.

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Arthritis Care Center Oklahoma

    Ardmore, Oklahoma 73401
    United States

    Site Not Available

  • Arthritis and Rheumatology; Center of Oklahoma PLLC

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Health Research of Oklahoma, Llc

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Lynn Health Science Inst.

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Healthcare Research Consultants

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • empty

    Portland, Oregon 97225
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Arthritis Associates

    Erie, Pennsylvania 16508
    United States

    Site Not Available

  • Arthritis Group

    Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • empty

    Pittsburgh, Pennsylvania 15237
    United States

    Site Not Available

  • Advanced Rheumatology & Arthritis Research Center

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Emkey Arthritis & Osteoporosis

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Low Country Rheumatology, PA

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Columbia Arthritis Center (Partnership Practice)

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Piedmont Arthritis Clinic

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Ramesh Gupta - PP

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Amarillo Center For Clinical Research

    Amarillo, Texas 79124
    United States

    Site Not Available

  • Austin Regional Clinic

    Austin, Texas 78731
    United States

    Site Not Available

  • Lovelace Scientific Resources Inc.

    Austin, Texas 78758
    United States

    Site Not Available

  • empty

    Baytown, Texas 77521
    United States

    Site Not Available

  • Diagnostic Group

    Beaumont, Texas 77701
    United States

    Site Not Available

  • AOCBV

    College Station, Texas 77845
    United States

    Site Not Available

  • Adriana Pop-Moody MD Clinic PA

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Arthritis Care & Diagnostic Center

    Dallas, Texas 75231-4406
    United States

    Site Not Available

  • Metroplex Clinical Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • Accurate Clinical Research

    Houston, Texas 77089
    United States

    Site Not Available

  • Houston Inst. For Clinical Research

    Houston, Texas 77074
    United States

    Site Not Available

  • IntraFusion Researh Network

    Houston, Texas 77007
    United States

    Site Not Available

  • Rheumatic Disease Clin Res Ctr

    Houston, Texas 77004
    United States

    Site Not Available

  • Southwest Rheumatology

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Accurate Clinical Management

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Arthiritis & Osteoporosis Centre of South Texas

    San Antonio, Texas 78232
    United States

    Site Not Available

  • NextGen Clinical Research Inc

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Arthritis Clinic Of Central Texas

    San Marcos, Texas 78666
    United States

    Site Not Available

  • Crossroads Clinical Research, LLC

    Victoria, Texas 77901
    United States

    Site Not Available

  • Arthritis & Osteoporosis Clinic

    Waco, Texas 76710
    United States

    Site Not Available

  • South Puget Sound Clinical Research

    Olympia, Washington 98502
    United States

    Site Not Available

  • Arthritis Northwest, Spokane

    Spokane, Washington 99204
    United States

    Site Not Available

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Mountain State Clinical Research

    Clarksburg, West Virginia 26301
    United States

    Site Not Available

  • Rheumatic Disease Center

    Glendale, Wisconsin 53217
    United States

    Site Not Available

  • Lakeshore Orthopedics

    Manitowoc, Wisconsin 54220
    United States

    Site Not Available

  • Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

    Onalaska, Wisconsin 54605
    United States

    Site Not Available

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