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Clinical Trial Summary

Osteoarthritis is a degenerative, chronic, and progressive joint disease considered as the most common joint disorder worldwide. In healthy joints, there is a continuous process of natural breakdown and repair of cartilage. This process becomes disrupted in OA, leading to degeneration and loss of articular cartilage, along with other joint changes, including subchondral bone remodeling, osteophyte formation, thickening of the capsule and sometimes inflammation of the synovia. JTA-004 is a plasma protein solution supplemented with HA and clonidine developed as a single IA injection for the treatment of knee OA. Local administration of JTA-004 into the joint cavity is intended to relieve chronic pain in subjects suffering from knee OA and discomfort associated with the IA administration. The JTA-004 Phase III study is a placebo and active-controlled, randomized, double-blind study to evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee at 3 months compared to placebo or active comparator. The study is expected to enrol 742 patients with mild to moderate symptomatic knee osteoarthritis in 22 centres in 6 European countries and Hong Kong SAR.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04333160
Study type Interventional
Source Bone Therapeutics S.A
Contact
Status Completed
Phase Phase 3
Start date March 10, 2020
Completion date December 9, 2021

See also
  Status Clinical Trial Phase
Withdrawn NCT02995083 - Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial Early Phase 1