Knee Osteoarthritis AS902330 First in Man,Proof of Concept,SAD & MAD

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, multicentre, single and multiple ascending dose study of AS902330 (rhFGF-18) administered intra-articularly in patients with knee primary osteoarthritis who are candidates for total knee replacement.

• IRAS ID

  1884

• Contact name

  andrew ostor

• Sponsor organisation

  Merck Serono International S.A.

• Eudract number

  2007-000127-18

• ISRCTN Number

  n/a

• Research summary

  Osteoarthritis is the most common form of joint disease and one of the most frequent morbidities in the elderly. According to the World Health Organization, approximately 25% of individuals over 60 years of age experience significant pain and disability as a result of osteoarthritis. Currently there is no disease modifying therapy and patients are treated for symptom management with pain killers and if this fails, eventually joint replacement surgery with its inherent costs and complications. This phase 1 study uses AS902330 a non glycosylated fibroblast growth factor 18 (FGF 18) injected straight into the joint. This is an anabolic agent (promoting constructive metabolism) and would hope to regrow some of the cartilage which is damaged and lost in osteoarthritis. This study will be performed in subjects on the waiting list for a total knee replacement. The agent will be injected into the joint and then the patient will be followed for up to 6 months (or sooner if surgery is performed) with an MRI scan and urine tests for markers of joint metabolism. (MRI to be performed only if planned date of Total Knee Replacement in the target knee is > 8 weeks after first injection of study drug). After their surgery their joint will be examined histologically. As this is a Phase 1 study, dose ranging will be formed starting at very low doses.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  08/H0605/107

• Date of REC Opinion

  22 Oct 2008

• REC opinion

  Further Information Favourable Opinion