A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

PHASE3CompletedINTERVENTIONAL
Enrollment

637

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

April 30, 2008

Study Completion Date

June 30, 2012

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Placebo injections

SC injections

DRUG

Placebo capsules

Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).

DRUG

Methotrexate capsules

Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.

BIOLOGICAL

Golimumab 50 mg injections

SC injections

BIOLOGICAL

Golimumab 100 mg injections

SC injections

Trial Locations (75)

Unknown

Birmingham

Mobile

Upland

Jacksonville

Miami

Coeur d'Alene

Moline

Springfield

Kansas City

Witchita

Saint Paul

Kansas City

Lincoln

Charlotte

Duncansville

Dallas

Fort Worth

Lubbock

Buenos Aires

Córdoba

Rosario

S.M. de Tucuman

San Miguel de Tucumán

Maroochydore

Melbourne

Vienna

Brussels

Liège

Winnipeg

St. John's

Rancagua

Santiago

Budapest

Gyula

Szombathely

Bangalore

Lucknow Gpo

Secunderabad

Precinct 7

Saemban

Selayang Baru Utara

Auckland

Timaru

Cebu

Manila

Quezon

Bialystok

Elblag

Kalisz

Szczecin

Warsaw

Moscow

Saratov

Yaroslavl

Singapore

Daejeon

Incheon

Seoul

Suwon

Madrid

Santander

Seville

Valencia

Kaohsiung City

Taichung

Taipei

Tiachung

Bangkok

Chiang Mai

Dnipropetrovsk

Donetsk

Kharkiv

Kiev

Leeds

London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Centocor, Inc.

INDUSTRY