A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis

PHASE3CompletedINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

March 31, 2007

Study Completion Date

January 31, 2012

Conditions
Spondylitis, Ankylosing
Interventions
BIOLOGICAL

golimumab

100 mg sc injections every 4 wks from wk 0 up to 5 yrs

BIOLOGICAL

Golimumab (CNTO 148); placebo

SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg

BIOLOGICAL

golimumab

50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg

Trial Locations (39)

Unknown

Paradise Valley

Los Angeles

San Francisco

Ormond Beach

Portland

Duncansville

Houston

Edmonds

Seattle

Brookfield

La Crosse

Brussels

Diepenbeek

Leuven

Edmonton

Vancouver

Victoria

Winnipeg

St. John's

Toronto

Sainte-Foy

Helsinki

Rauma

Nantes Cedex 01 N/A

Bad Nauheim

Baden-Baden

Berlin

Erlangen

Hanover

Herne

München

Maastricht

Nijmegen

Busan

Pusan

Seoul

Kaohsiung City

Taichung

Taoyuan District

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Centocor, Inc.

INDUSTRY