Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

Completed · Phase 1 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

Key facts

Study ID

NCT00686868

Run by

GlaxoSmithKline

People needed

35

Starts

2008-06-13

Expected to finish

2011-05-02

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Anniston, Alabama, United States
• GSK Investigational Site — Miramar, Florida, United States
• GSK Investigational Site — Randwick, New South Wales, Australia
• GSK Investigational Site — Adelaide, South Australia, Australia
• GSK Investigational Site — Heidelberg, Victoria, Australia
• GSK Investigational Site — Melbourne, Victoria, Australia
• GSK Investigational Site — Brussels, Belgium
• GSK Investigational Site — Leuven, Belgium
• GSK Investigational Site — Échirolles, France
• GSK Investigational Site — Verona, Veneto, Italy
• GSK Investigational Site — Christchurch, New Zealand
• GSK Investigational Site — Bydgoszcz, Poland
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Ryazan, Russia
• GSK Investigational Site — Smolensk, Russia
• GSK Investigational Site — Yaroslavl, Russia
• GSK Investigational Site — Madrid, Spain

Full record on ClinicalTrials.gov

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