Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

PHASE2CompletedINTERVENTIONAL
Enrollment

465

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Rituximab

Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.

DRUG

Methotrexate

Participants will receive methotrexate 10-25 mg/week orally or parenterally.

DRUG

Methylprednisolone

Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.

DRUG

Folic Acid

Participants will receive folic acid \>= 5 mg/week or equivalent.

Trial Locations (92)

2025

Auckland

3168

Melbourne

4558

Maroochydore

6979

Perth

9000

Ghent

10700

Mexico City

11021

Great Neck

11787

Smithtown

11803

Plainview

14618

Rochester

15706

Santiago de Compostela

16132

Genoa

16635

Duncansville

18120

Heinola

20157

Milan

27157

Winston-Salem

27834

Greenville

28006

Madrid

28007

Madrid

28046

Madrid

33100

Udine

33143

South Miami

33180

Aventura

33334

Fort Lauderdale

33486

Boca Raton

33773

Largo

35294

Birmingham

38320

San Cristóbal de La Laguna

40882

Ratingen

41014

Seville

41100

Modena

44122

Beachwood

44143

Mayfield

44620

México

45402

Dayton

46260

Indianapolis

50924

Cologne

53217

Glendale

54401

Wausau

55416

Minneapolis

60611

Chicago

60637

Chicago

63141

St Louis

64460

Monterrey

72205

Little Rock

74104

Tulsa

74135

Tulsa

75231

Dallas

77074

Houston

80920

Colorado Springs

83702

Boise

84132

Salt Lake City

85381

Peoria

92037

La Jolla

92108

San Diego

92270

Rancho Mirage

92813

Long Beach

93053

Regensburg

97080

Würzburg

97239

Portland

98104

Seattle

3109601

Haifa

3339419

Haifa

46202-5149

Indianapolis

02215

Boston

03756

Lebanon

08043

Voorhees Township

80030-110

Curtiba

13083-888

Campinas

04026-000

São Paulo

T2N 4Z6

Calgary

V5Z 1L7

Vancouver

A1A 5E8

St. John's

N6A 4V2

London

128 50

Prague

00290

Helsinki

04103

Leipzig

06726

Mexico City

0620

Auckland

15-351

Bialystok

20-022

Lublin

61-545

Poznan

02-637

Warsaw

50-556

Wroclaw

06800

Mérida

413 45

Gothenburg

171 76

Stockholm

B29 6JD

Birmingham

CB2 2QQ

Cambridge

WS11 5XY

Cannock

LS7 4SA

Leeds

ST6 7AG

Stoke-on-Trent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

NCT02093026 - Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) | Biotech Hunter | Biotech Hunter