An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

PHASE3CompletedINTERVENTIONAL
Enrollment

2,067

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Tocilizumab

For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.

DRUG

Disease-modifying anti-rheumatic drugs

Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.

DRUG

Non-steroidal anti-inflammatory drugs

Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.

DRUG

Oral corticosteroids

Oral corticosteroids (≤ 10 mg/day) were permitted during the study.

Trial Locations (295)

11

Lima

13

Lima

108

Reykjavik

852

Hong Kong

Tuenmen

1000

Ljubljana

1011

Lausanne

1862

Diepkloof

2000

Maribor

2040

Radiokop

2050

Sydney

2170

Merksem

2609

Lillehammer

2900

Hellerup

3144

Malvern

3500

Hasselt

4001

Cape Town

Durban

4102

Woolloongabba

6008

Shenton Park

7000

Hobart

7405

Pinelands

7500

Cape Town

7600

Levanger

10021

New York

10103

San José

10117

Berlin

10330

Bangkok

10400

Bangkok

11000

Belgrade

11020

Great Neck

11803

Plainview

12206

Albany

13210

Syracuse

13285

Marseille

13905

Binghamton

14050

Mexico City

14127

Orchard Park

14642

Rochester

15261

Pittsburgh

15706

Santiago de Compostela

16132

Genova

16635

Duncansville

17176

Stockholm

17822

Danville

18015

Bethlehem

18103

Allentown

18250

Niška Banja

19090

Willow Grove

19152

Philadelphia

19610

Wyomissing

19713

Newark

20157

Milan

20902

Wheaton

21702

Frederick

22320

Tijuana

23320

Chesapeake

23502

Norfolk

25123

Brescia

27100

Pavia

27609

Raleigh

27704

Durham

28046

Madrid

28210

Charlotte

28602

Hickory Grove

28803

Asheville

29010

Málaga

29204

Columbia

29406

Charleston

29601

Greenville

29609

Brest

30342

Atlanta

31048

Haifa

31059

Toulouse

31134

Hildesheim

32400

Panama City

33076

Bordeaux

33100

Udine

33180

Aventura

33334

Fort Lauderdale

33407

West Palm Beach

33484

Delray Beach

33609

Tampa

33614

Tampa

34239

Sarasota

34295

Montpellier

34354

Haifa

34684

Palm Habor

Palm Harbor

35128

Padua

35144

Panevezys

35203

Rennes

35801

Huntsville

36001

Pontevedra

37000

León

37203

Nashville

37343

Hixson

38042

Grenoble

38305

Jackson

38802

Tupelo

39232

Flowood

39245

Gommern

40202

Louisville

40515

Lexington

40620

Jyväskylä

42102

Bowling Green

42277

Saint-Priest-en-Jarez

44035

Nantes

44109

Cleveland

44340

Guadalajara

44620

Guadalajara

44652

Herne

44718

Canton

45219

Cincinnati

45235

Guadalajara

45239

Essen

45408

Dayton

48324

Sendenhorst

48903

Barakaldo

48910

Lansing

49048

Kalamazoo

49074

Osnabrück

49546

Grand Rapids

50009

Kaunas

50200

Chiang Mai

50322

Des Moines

50924

Cologne

52064

Aachen

52401

Cedar Rapids

53100

Siena

53217

Glendale

54601

La Crosse

55121

Eagan

55426

Saint Louis Park

56100

Pisa

56303

Saint Cloud

58501

Bismarck

59037

Lille

60053

Morton Grove

60061

Vernon Hills

62704

Springfield

63117

St Louis

63128

St Louis

63131

St Louis

63141

St Louis

65191

Wiesbaden

65807

Springfield

67098

Strasbourg

68516

Lincoln

69437

Lyon

69495

Pierre-Bénite

70300

Rishon LeZiyyon

70458

Slidell

70808

Baton Rouge

71103

Shreverport

72205

Little Rock

73103

Oklahoma City

73109

Oklahoma City

73112

Oklahoma City

74104

Tulsa

74135

Tulsa

75150

Mesquite

75181

Paris

75231

Dallas

75679

Paris

76031

Rouen

76231

Šiauliai

77074

Houston

78306

Ashkelon

78705

Austin

78749

Austin

79124

Amarillo

80045

Willow Grove

80054

Amiens

80335

München

80910

Colorado Springs

81541

München

83404

Idaho Falls

83642

Meridian

83702

Boise

85208

Mesa

85251

Scottsdale

85253

Paradise Valley

85258

Scottsdale

85381

Peoria

85723

Tucson

85724

Tucson

87131

Albuquerque

89502

Reno

90045

Los Angeles

90095

Los Angeles

90185

Umeå

90505

Torrance

90806

Long Beach

90808

Long Beach

91786

Upland

92101

San Diego

92104

Boulogne-Billancourt

92108

San Diego

92260

Palm Desert

92262

Palm Springs

92288

Klaipėda

92801

Anaheim

93454

Santa Maria

94270

Le Kremlin-Bicêtre

94304

Palo Alto

94578

San Leandro

95126

San Jose

97080

Würzburg

97401

Eugene

97504

Medford

98043

Mountlake Terrace

98104

Seattle

98195

Seattle

98405

Tacoma

98502

Olympia

99204

Spokane

100032

Beijing

100044

Beijing

105203

Moscow

115522

Moscow

117049

Moscow

190068

Saint Petersburg

191015

Saint Petersburg

200127

Shanghai

200433

Shanghai

230022

Hefei Anhui

250012

Jinan

300053

Tula

390026

Ryazan

510630

Guangzhou

20551030

Rio de Janeiro

35294-7201

Birmingham

46202-5149

Indianapolis

04102

Portland

02111

Boston

01201

Pittsfield

59107-5100

Billings

03820

Dover

08035

Haddon Heights

Barcelona

08903

New Brunswick

07055

Passaic

27599-7280

Chapel Hill

02919

Johnston

75231-4406

Dallas

05401

Burlington

C1015ABO

Buenos Aires

C1428DQG

Buenos Aires

S2000PBJ

Rosario

B1878DVB

San Juan Bautista

13060-803

Campinas

74653-050

Goiânia

T2V 1P9

Calgary

T5H 3V9

Edmonton

V8V 3P9

Victoria

R3A 1M3

Winnipeg

A1A 5E8

St. John's

L7R 1E2

Burlington

L8N 2B6

Hamilton

N2M 5N6

Kitchener

N6A 4V2

London

L5M 2V8

Mississauga

K1H 1A2

Ottawa

M5T 3L9

Toronto

H2L 1S6

Montreal

G1V 3M7

Québec

G1W 4R4

Sainte-Foy

S7N 0W8

Saskatoon

500 05

Hradec Králové

128 50

Prague

140 59

Prague

00290

Helsinki

06202

Nice

01067

Dresden

LT-08661

Vilnius

06700

Mexico City

07760

Mexico City

6525 GA

Nijmegen

1349-019

Lisbon

00716

Ponce

0002

Pretoria

RG24 9NA

Basingstoke

B29 6JD

Birmingham

WS11 5XY

Cannock

DE1 2QY

Derby

LS7 4SA

Leeds

SE1 9RT

London

M13 9WL

Manchester

M41 5SL

Manchester

TS4 3BW

Middlesbrough

NE1 4LP

Newcastle upon Tyne

OX3 7LD

Oxford

SO16 6YD

Southampton

ST6 7AG

Stoke-on-Trent

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00720798 - An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies | Biotech Hunter | Biotech Hunter