A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

619

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

March 31, 2011

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Tocilizumab

Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.

DRUG

Placebo

Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.

DRUG

Permitted DMARDs

As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.

Trial Locations (157)

10003

New York

10029

New York

10451

The Bronx

10817

Bethlehem

11501

Mineola

11787

Smithtown

14127

Orchard Park

15090

Wexford

15261

Pittsburgh

19102

Philadelphia

19152

Philadelphia

20006

Washington D.C.

20902

Wheaton

22015

Burke

22102

Reston

24153

Salem

25801

Beckley

26301

Clarksburg

27408

Greensboro

27704

Durham

27834

Greenville

28012

Belmont

28209

Charlotte

28210

Charlotte

28601

Hickory

29204

Columbia

29407

Charleston

29506

Florence

29572

Myrtle Beach

29601

Greenville

29732

Rock Hill

30342

Atlanta

30513

Blue Ridge

31030

Fort Valley

32073

Orange Park

32746

Lake Mary

32804

Orlando

32901

Melbourne

33133

Miami

33317

Plantation

33321

Tamarac

33334

Fort Lauderdale

33609

Tampa

34239

Sarasota

34474

Ocala

34684

Palm Harbor

34698

Dunedin

35205

Birmingham

35215

Birmingham

36111

Montgomery

37073

Hendersonville

37203

Nashville

37909

Knoxville

38119

Memphis

38305

Jackson

38555

Crossville

38802

Tupelo

39232

Flowood

40515

Lexington

42102

Bowling Green

43551

Perrysburg

43701

Zanesville

44122

Beechwood

44130

Middleburg Heights

44143

Mayfield

44333

Akron

46321

Munster

46601

South Bend

47714

Evansville

48080

Saint Clair Shores

49009

Kalamazoo

53209

Milwaukee

54401

Wausau

54605

Onalaska

55121

Eagan

57105

Sioux Falls

57201

Watertown

57701

Rapid City

57702

Rapid City

59101

Billings

59802

Missoula

59907

Kalispell

60515

Downers Grove

62704

Springfield

63031

Florissant

63141

St Louis

66209

Leawood

68803

Grand Island

70112

New Orleans

70808

Baton Rouge

70810

Baton Rouge

71203

Monroe

72401

Jonesboro

73069

Norman

73103

Oklahoma City

73104

Oklahoma City

75007

Carrollton

75150

Mesquite

75231

Dallas

76107

Fort Worth

76508

Temple

76708

Waco

77004

Houston

77034

Houston

77074

Houston

77090

Houston

77401

Bellaire

78217

San Antonio

78229

San Antonio

78258

San Antonio

79106

Amarillo

79124

Amarillo

80045

Willow Grove

80910

Colorado Springs

83404

Idaho Falls

83687

Nampa

83702

Boise

84132

Salt Lake City

85251

Scottsdale

85253

Paradise Valley

85258

Scottsdale

85381

Peoria

86403

Lake Havasu City

89106

Las Vegas

89128

Las Vegas

89502

Reno

90095

Los Angeles

90211

Beverly Hills

90404

Santa Monica

90606

Whittier

90815

Long Beach

91107

Pasadena

91405

Van Nuys

91786

Upland

92025

Escondido

92037

La Jolla

93454

Santa Maria

94598

Walnut Creek

97035

Lake Oswego

97239

Portland

97302

Salem

98133

Seattle

98195

Seattle

311794

Tifton

35294-7201

Birmingham

06611

Trumbull

02048

Mansfield

01605

Worcester

01610

Worcester

03820

Dover

07728

Freehold

08903

New Brunswick

07055

Passaic

07666

Teaneck

05401

Burlington

99204-2336

Spokane

00918

San Juan

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00531817 - A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter