Knee Osteoarthritis Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Primary Osteoarthritis of the Knee Who Are Not Expected to Require Knee Surgery Within One Year
Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those
that are weight bearing such as the knees. OA is considered to be a disease of the cartilage
in the joints even though it involves the whole joint, including the bone and synovium (thin
lining of the joints which produces synovial fluid). With time, more and more of the
cartilage is destroyed by the disease with inflammation commonly occurring.
AS902330 is expected to increase the production and development of specific bone cells:
chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is
expected to lead to repair and generation of the cartilage, and a narrowing of the space
width between the knee joints in a selected region of the knee cartilage. The purpose of
this study is to see how safe treatment with AS902330 is, and to evaluate its effect on the
knee cartilage. In addition, the study will also measure the effects of AS902330 in the
blood, which reflect disease activity.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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