Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

January 1, 2008

Primary Completion Date

June 8, 2009

Study Completion Date

July 15, 2013

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

ofatumumab

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period

DRUG

Placebo

1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Trial Locations (45)

1023

GSK Investigational Site, Budapest

1459

GSK Investigational Site, Gauteng

1878

GSK Investigational Site, Quilmes

2000

GSK Investigational Site, Rosario

2050

GSK Investigational Site, Camperdown

2170

GSK Investigational Site, Merksem

3144

GSK Investigational Site, Malvern

3168

GSK Investigational Site, Clayton

4000

GSK Investigational Site, San Miguel de Tucumán

GSK Investigational Site, Liège

4558

GSK Investigational Site, Maroochydore

5000

GSK Investigational Site, Córdoba

6008

GSK Investigational Site, Shenton Park

7505

GSK Investigational Site, Parow

9024

GSK Investigational Site, Győr

15337

GSK Investigational Site, Bialystok

18012

GSK Investigational Site, Granada

29010

GSK Investigational Site, Málaga

39008

GSK Investigational Site, Santander

41071

GSK Investigational Site, Seville

85168

GSK Investigational Site, Bydgoszcz

115522

GSK Investigational Site, Moscow

150003

GSK Investigational Site, Yaroslavl

190068

GSK Investigational Site, Saint Petersburg

410012

GSK Investigational Site, Saratov

620102

GSK Investigational Site, Yekaterinburg

2570017

GSK Investigational Site, Viña del Mar

7501126

GSK Investigational Site, Santiago

8380456

GSK Investigational Site, Santiago

C1419AHN

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

Unknown

GSK Investigational Site, Santiago

GSK Investigational Site, Santander

722 00

GSK Investigational Site, Ostrava Trebovice

128 50

GSK Investigational Site, Prague

760 01

GSK Investigational Site, Zlín

Callao 2

GSK Investigational Site, Callao

Lima 27

GSK Investigational Site, Lima

15-351

GSK Investigational Site, Bialystok

02-256

GSK Investigational Site, Warsaw

50-088

GSK Investigational Site, Wroclaw

020047

GSK Investigational Site, Bucharest

WN6 9EP

GSK Investigational Site, Wigan

WS11 5XY

GSK Investigational Site, Cannock

E11 1NR

GSK Investigational Site, Leytonstone, London

ME16 9QQ

GSK Investigational Site, Maidstone

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00611455 - Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy | Biotech Hunter | Biotech Hunter