Isolated Cartilage Injury of the Knee Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Trial to Investigate the Efficacy and Safety of Weekly Intra-articular (i.a.) Injections of 10, 30, and 100 µg of AS902330 for Three Consecutive Weeks in Patients With Acute Cartilage Injury of the Knee
Many people all over the world suffer from cartilage injuries in the knee. Symptoms include
pain, joint swelling, and loss of function. Without repair, cartilage injury may ultimately
lead to osteoarthritis (OA). Natural healing is poor, and to date treatment is available
only for deep cartilage defects involving also the underlying bone. A promising candidate
for drug treatment of cartilage injury is AS902330, a recombinant form of the human
fibroblast growth factor (FGF) 18.
So far, the drug has been used in subjects with different stages of knee OA in two ongoing
studies without emerging safety issues following single and multiple intra-articular
injections of ascending doses. However, OA represents late-stage cartilage injury, where
repair might be difficult due to diffuse damage, reduced responsiveness of the cartilage,
and/or the involvement of other joint structures.
This clinical trial is meant to provide the proof of concept and to identify an efficacious
dose of AS902330 for the treatment of adult subjects with acute cartilage injuries of the
knee. The first subject for this trial was treated on the 19th of April 2010.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment