A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2007

Study Completion Date

September 30, 2009

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Golimumab

2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes

DRUG

Methotrexate

Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.

DRUG

Placebo

Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.

Trial Locations (72)

Unknown

Peoria

Aventura

Orlando

Tampa

Atlanta

Lincoln

Omaha

Voorhees Township

Albany

Roslyn

Charlotte

Oklahoma City

Duncansville

Norristown

West Reading

Willow Grove

Amarillo

Fort Worth

Lubbock

Spokane

Buenos Aires

Córdoba

Rosario

San Juan

San Miguel de Tucumán

Santa Fe

Fitzroy

Heidelberg

Maroochydore

Melbourne

Perth

Woodville

Barranquilla

Bogotá

Bucaramanga

Floridablanca

Erlangen

Hamburg

Magdeburg

München

Budapest

Szolnok

Daugavpils

Riga

Kaunas

Klaipėda

Šiauliai

Vilnius

Ipoh

Kuching

Precinct 7

Selangor Darul Ehasan

Msd06 Gwardiamangia

Colonia del Valle

Guadalajara

Guadalajara Jalisco

Monterrey

Christchurch

Dunedin

Rotorua

Takapuna Auckland

Timaru

Lima

Bialystok

Elblag

Krakow

Warsaw

Włoszczowa

Kiev

Kyiv

Symferpol

Zhaporizhzhya

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Centocor, Inc.

INDUSTRY

NCT00361335 - A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Biotech Hunter | Biotech Hunter