OSM105196 GSK315234 Phase II Rheumatoid Arthritis Patient Biopsy Study

• Research type

  Research Study

• Full title

  A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis

• IRAS ID

  43998

• Contact name

  Jacob M van Laar

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-012055-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  What are the effects of a new drug (GSK315234) on the tissue between joints and bones of people with rheumatoid arthritis (RA)? This study is sponsored by GlaxoSmithKline (GSK), and will be performed at research sites in the UK and Europe. GSK315234 is a monoclonal antibody in development for the treatment of RA. The majority of RA patients continue to suffer with the disease which causes pain, inflammation (swelling) and joint destruction. As such, there is a need for new, safe treatments. Changes in cells found in the synovial tissue (tissue in between the joints) may be predictive of potential clinical effects of treatment with GSK315234. This study is being conducted in RA patients to find out what changes occur in the synovial tissue of joints and if changes occur in bones after receiving GSK315234. The study will also evaluate any side effects of GSK315234; how much GSK315234 gets into the bloodstream and how long it takes the body to get rid of it; and if antibodies (protein that the body produces for defense) against GSK315234 are made after taking GSK315234. Subjects will receive an infusion of either GSK315234 (3 mg/kg) or placebo (liquid with no drug in it), and then return to the research facility for regular visits over the next 16 weeks. Synovial tissue will be collected by a biopsy (approximately 20 small samples of the tissue are removed from an inflamed joint) and magnetic resonance imaging (MRI) of joints will be performed on two occasions (once before and once after dosing). Biomarkers (e.g., cells, proteins) will be measured in the synovial tissue, blood and urine. Blood samples will be collected for pharmacokinetics (measurement of how much drug is in the blood) and immunogenicity (measurement of any antibodies to GSK315234). Safety will be monitored throughout the study.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  10/H0906/31

• Date of REC Opinion

  24 Jun 2010

• REC opinion

  Further Information Favourable Opinion