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

PHASE3TerminatedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

July 31, 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 IV infusion taken 14 days apart. A total of 8 infusion cycles given over a 144 week period

DRUG

Placebo

1000 mL sterile, pyrogen free 0.9% NaCl. A treatment cycle consisting of two IV infusion taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period

Trial Locations (60)

2000

GSK Investigational Site, Rosario

2609

GSK Investigational Site, Lillehammer

2730

GSK Investigational Site, Herlev

4000

GSK Investigational Site, San Miguel de Tucumán

5000

GSK Investigational Site, Córdoba

7006

GSK Investigational Site, Trondheim

7600

GSK Investigational Site, Levanger

8600

GSK Investigational Site, Silkeborg

10559

GSK Investigational Site, Berlin

14129

GSK Investigational Site, Berlin

14467

GSK Investigational Site, Potsdam

16132

GSK Investigational Site, Genoa

20132

GSK Investigational Site, Milan

20157

GSK Investigational Site, Milan

20162

GSK Investigational Site, Milan

21100

GSK Investigational Site, Varese

22081

GSK Investigational Site, Hamburg

22415

GSK Investigational Site, Hamburg

28007

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28905

GSK Investigational Site, Getafe/Madrid

30625

GSK Investigational Site, Hanover

31059

GSK Investigational Site, Toulouse

35121

GSK Investigational Site, Padua

38434

GSK Investigational Site, Échirolles

39008

GSK Investigational Site, Santander

39112

GSK Investigational Site, Magdeburg

41071

GSK Investigational Site, Seville

46005

GSK Investigational Site, Cahors

46017

GSK Investigational Site, Valencia

49074

GSK Investigational Site, Osnabrück

59100

GSK Investigational Site, Prato

67098

GSK Investigational Site, Strasbourg

69120

GSK Investigational Site, Heidelberg

80054

GSK Investigational Site, Amiens

80131

GSK Investigational Site, Napoli

82100

GSK Investigational Site, Telese Terme (BN)

91054

GSK Investigational Site, Erlangen

91106

GSK Investigational Site, Corbeil-Essonnes

AAL1426

GSK Investigational Site, Ciudad Autónoma de Buenos Aires

04109

GSK Investigational Site, Leipzg

00161

GSK Investigational Site, Rome

1056 AB

GSK Investigational Site, Amsterdam

7511JX

GSK Investigational Site, Enschede

8011 JW

GSK Investigational Site, Zwolle

N-5528

GSK Investigational Site, Haugesund

Lima 27

GSK Investigational Site, Lima

400-711

GSK Investigational Site, Incheon

110-744

GSK Investigational Site, Seoul

120-752

GSK Investigational Site, Seoul

133-792

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

06800

GSK Investigational Site, Mérida (Badajoz)

SE-313 92

GSK Investigational Site, Oskarström

SE-171 76

GSK Investigational Site, Stockholm

ML2 0DP

GSK Investigational Site, Wishaw

NE1 4LP

GSK Investigational Site, Newcastle

WS11 5XY

GSK Investigational Site, Cannock

DD1 9SY

GSK Investigational Site, Dundee

E11 1NR

GSK Investigational Site, Leytonstone, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00603525 - Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy | Biotech Hunter | Biotech Hunter