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

PHASE3CompletedINTERVENTIONAL
Enrollment

718

Participants

Timeline

Start Date

November 7, 2013

Primary Completion Date

October 14, 2016

Study Completion Date

October 14, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Tocilizumab (TCZ)

TCZ will be administered at a dose of 162 milligrams (mg) via SC injection weekly (if body weight is greater than or equal to \[\>/=\] 100 kilograms \[kg\]) or every 2 weeks (if body weight was less than \[\<\] 100 kg).

DRUG

Methotrexate (MTX)

MTX will be administered at a stable dose (15 mg to 25 mg per week) orally.

DRUG

Placebo (PBO)

PBO matching to MTX will be administered orally.

Trial Locations (155)

10016

Manhattan Medical Reserach, New York

11030

Manhasset Rheumatology, Manhasset

11201

Arthritis & Osteoporosis Center, Brooklyn

11787

Rheumatology Associates of Long Island, Smithtown

11803

Office of Premier Chatpar Md, Plainview

12203

The Center for Rheumatology, Albany

13210

Arthritis Health Associates, Syracuse

14127

Buffalo Rheumatology Associates, Orchard Park

15090

Advanced Rheumatology & Arthritis Research Center, Wexford

16508

Arthritis Associates, Erie

16635

Altoona Center For Clinical Research, Duncansville

19152

Arthritis Group, Philadelphia

19610

Clinical Research Center of Reading, Wyomissing

Emkey Arthritis & Osteoporosis, Wyomissing

19713

Javed Rheumatology Associates, Inc., Newark

19958

Rheumatolgy Consultants of Deleware, Lewes

21740

Klein & Associates, M.D., P.A., Hagerstown

26301

Mountain State Clinical Research, Clarksburg

27408

Medication Management, Greensboro

27617

Shanahan Rheumatology & Immunology, PLLC, Raleigh

27704

Triangle Orthopaedics Associates, P.A., Durham

28210

Carolina Bone & Joint P.A., Charlotte

28451

Cape Fear Arthritis Care, Leland

28602

PMG Research of Hickory LLC, Hickory

28803

Asheville Arthritis & Osteoporosis Center, PA, Asheville

29204

Columbia Arthritis Center (Partnership Practice), Columbia

29406

Low Country Rheumatology, PA, Charleston

29601

Piedmont Arthritis Clinic, Greenville

30046

North Georgia Rheumatology Group, PC, Lawrenceville

30096

North Georgia Rheumatology, Duluth

30501

Arthritis Center of North Georgia, Gainesville

32806

Rheumatology Associates of Central Florida, Orlando

32836

Arthritis and Rheumatology Clinic, Orlando

33016

Precision Research Organization, Miami Lakes

33135

Suncoast Research Group LLC, Miami

33136

South Coast Research Center, Inc., Miami

33180

Arthritis & Rheumatism; Disease Specialities, Aventura

33321

West Broward Rheumatology Associates, Inc., Tamarac

33613

McIlwain Medical Group, Tampa

33614

Burnette & Silverfield, MDS, Tampa

33708

Pinellas Medical Research - Allegry & Rheumatology Associates, LLC, St. Petersburg

34102

Jeffrey Alper M.D Research, Naples

34239

Sarasota Arthritis Res Center, Sarasota

34684

Arthritis Center Palm Harbor, Palm Harbor

Arthritis Rsrch of Florida, Inc., Palm Harbor

34698

Robert Levin, Md; Research Dept, Dunedin

34787

Advanced Clinical Research of Orlando, Inc., Winter Garden

35294

Uni Of Alabama,Birmingham; Medicine - Rheumatology, Birmingham

35406

Clnical & Translational Reseach Center for Alabama, PC, Tuscaloosa

35801

Rheumatology Associates of North Alabama, Huntsville

36207

Pinnacle Research Group; Llc, Central, Anniston

38119

Ramesh Gupta - PP, Memphis

38305

West Tennessee Research Institute, Jackson

39232

Arthritis and Osteoporosis; Treatment and Research Center, Flowood

Jackson Arthritis Clinic, Flowood

40515

Bluegrass Comm Research, Inc., Lexington

43203

Ohio State University; Rheumatology; Immun/Rheum, Columbus

43215

Columbus Arthritis Center, Columbus

43606

Clinical Research Source, Inc., Toledo

44109

University Hospitals Case Medical Center, Cleveland

44130

Paramount Medical Research, Middleburg Heights

44333

Crystal Arthritis Center, Inc., Akron

45219

Cincinnati Rheumatic Disease Study Group, Cincinnati

45417

STAT Research Inc, Dayton

46202

Indiana Uni Medical Center, Indianapolis

46227

Diagnostic Rheumatology & Research, Indianapolis

48081

Shores Rheumatology, Saint Clair Shores

48910

Advanced Rheumatology, PC, Lansing

Fiechtner Research Inc, Lansing

49770

Nisus Research/Northern Michigan Hospital, Petoskey

53217

Rheumatic Disease Center, Glendale

54220

Lakeshore Orthopedics, Manitowoc

54605

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

55121

St. Paul Rheumatology, Eagan

55805

St. Luke's Hospital Association of Duluth, Duluth

58501

St. Alexius Medical Center; Arthritis Clinic, Bismarck

58507

Odyssey Research Services; Main Medical Building, Bismarck

62703

Springfield Clinic, Springfield

63031

David S Rosenberg, Florissant

63117

Clayton Medical Research, St Louis

63141

Arthritis Consultants, St Louis

64111

Clinical Research Consultants,LLC, Kansas City

66209

Kansas City Internal Medicine, Overland Park

71203

Arthritis & Diabetes Clinic, Inc, Monroe

71913

CHI St. Vincent Medical Group Hot Springs, Hot Springs

72205

Little Rock Diagnostic Clinic, Little Rock

72401

NEA Baptist Clinic, Jonesboro

72903

Fort Smith Rheumatology, PC, Fort Smith

73103

Arthritis and Rheumatology; Center of Oklahoma PLLC, Oklahoma City

Health Research of Oklahoma, Llc, Oklahoma City

73112

Lynn Health Science Inst., Oklahoma City

73401

Arthritis Care Center Oklahoma, Ardmore

74104

Oklahoma Center For Arthritis Therapy & Research, Tulsa

74135

Healthcare Research Consultants, Tulsa

75150

Southwest Rheumatology, Mesquite

75231

Metroplex Clinical Research, Dallas

76710

Arthritis & Osteoporosis Clinic, Waco

77004

Rheumatic Disease Clin Res Ctr, Houston

77007

IntraFusion Researh Network, Houston

77074

Houston Inst. For Clinical Research, Houston

77089

Accurate Clinical Research, Houston

77701

Diagnostic Group, Beaumont

77845

AOCBV, College Station

77901

Crossroads Clinical Research, LLC, Victoria

78229

Accurate Clinical Management, San Antonio

NextGen Clinical Research Inc, San Antonio

78232

Arthiritis & Osteoporosis Centre of South Texas, San Antonio

78404

Adriana Pop-Moody MD Clinic PA, Corpus Christi

78666

Arthritis Clinic Of Central Texas, San Marcos

78731

Austin Regional Clinic, Austin

78758

Lovelace Scientific Resources Inc., Austin

79124

Amarillo Center For Clinical Research, Amarillo

80045

University of Colorado Hospital, Aurora

80920

Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs, Colorado Springs

83404

Institute of Arthritis Research, Idaho Falls

85027

Valley Arthritis Care, Phoenix

85202

Arizona Arthritis & Rheumatology Research, Pllc, Mesa

Arizona Arthritis and Rheuma, Mesa

85258

Advanced Arthritis Care & Research, Scottsdale

85306

Arizona Arthritis & Rheumatology Associates, P.C., Glendale

87102

Albuquerque Clinical Trials, Albuquerque

88011

Arthritis and Osteoporosis Associates of New Mexico, Las Cruces

89128

G. T. Kelly, MD, Las Vegas

90606

Medvin Clinical Research, Whittier

90720

Valerius Medical Group, Los Alamitos

91723

Medvin Clinical Research, Covina

92020

TriWest Research Associates, LLC, El Cajon

92108

San Diego Arthritis Med Clnc, San Diego

92543

CV Mehta MD Medical Corp, Hemet

92835

St. Jude Hospital Yorba Linda DBA St. Joseph, Fullerton

92868

NRC Research Institute, Orange

94578

C Michael Neuwelt MD Inc, San Leandro

98502

South Puget Sound Clinical Research, Olympia

98801

Wenatchee Valley Hospital & Clinics, Wenatchee

99204

Arthritis Northwest, Spokane, Spokane

91785-1141

Inland Rheumatology; Clinical Trials, Inc., Upland

80230-7127

Denver Arthritis Clinic, Denver

06606

Joao Nascimento, Bridgeport

06810

Clinical Research Center of Ct/Ny, Danbury

06518

Arthritis & Osteoporosis Center Pc, Hamden

06611

New England Research Associates, Trumbull

02111

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

02720

Phase Iii Clinical Research, Fall River

02048

Mansfield Medical Center, Mansfield

01605

Reliant Medical Group, Inc; Rheumatology, Worcester

UMass Memorial Medical Center, Worcester

01610

Clinical Pharmacology Study Group, Worcester

03756

Rheumatology Research Group, Lebanon

03060

Nashua Rheumatology - Foundation Medical Partners, Nashua

07726

Arthritis and Osteoporosis Associates, Manalapan

08755

Atlantic Coast Rheumatology, Toms River

08775

Ocean Rheumatology, Toms River

08043

Arthritis Rheumatic & Back Disease Associates, Voorhees Township

Cooper Cancer Institute, Voorhees Township

75231-4406

Arthritis Care & Diagnostic Center, Dallas

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01855789 - A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX | Biotech Hunter | Biotech Hunter