An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

May 31, 2012

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Golimumab 100 mg

Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.

DRUG

Golimumab 50 mg

Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.

DRUG

Methotrexate

Participants will receive methotrexate capsules weekly.

DRUG

Placebo injection

Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.

DRUG

Placebo capsules

Participants will receive placebo capsules weekly

Trial Locations (50)

Unknown

Mobile

Palo Alto

Pasadena

Upland

Ormond Beach

Palm Harbor

Moline

Kansas City

St Louis

Lincoln

Omaha

Duncansville

Richmond

Buenos Aires

Córdoba

Rosario

S.M. de Tucuman

San Miguel de Tucumán

Clayton

Maroochydore

Melbourne

Victoria

St. John's

Ottawa

Toronto

Sainte-Foy

Hamilton Ontario

Rancagua

Santiago

Temuco IX

Berlin

Cologne

Hamburg

Hanover

Leipzig

Rostock

Budepest

Monterrey

Auckland

Rotorua

Timaru

Elblag

Kalisz

Szczecin

Warsaw

Anyang

Daegu

Pusan

Seoul

Kaohsiung County

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Centocor, Inc.

INDUSTRY