A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis

Summary

Osteoarthritis (OA) is the most common joint disease affecting millions of people around the world, for which there is unfortunately no cure. Among existing therapies, viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an established place in the symptomatic treatment of knee OA. The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in two phases. With results obtained in the first phase the best dose of JTA-004 is determined, and the efficacy of the selected dose will then be confirmed in the second phase.

Timeline

Start

2016-02

Primary completion

2018-04-27

Completion

2018-04-27

Outcome

Missed primary endpoint

registry analysis (superiority test); JTA-004 100 (2 mL) vs Reference Product; p = 0.141; NCT02740231 ↗

paper statistical superiority of JTA-200/2 over the reference was not demonstrated. PMID 34666767 ↗

Publications

• Bettonville M, Leon M, Margaux J, Urbin-Choffray D, Theunissen E, Besse-Hammer T, Fortems Y, Verlinden S, Godeaux O, Delmarcelle AS, Kaux JF. Safety and efficacy of a single intra-articular injection of a novel enhanced protein solution (JTA-004) compared to hylan G-F 20 in symptomatic knee osteoarthritis: a randomized, double-blind, controlled phase II/III study. BMC Musculoskelet Disord. 2021 Oct 19;22(1):888. doi: 10.1186/s12891-021-04750-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JTA-004	Protein / enzyme biologic	50 ug/ml	Other
Subject	JTA-004	Protein / enzyme biologic	100 ug/ml	Other
Subject	JTA-004	Protein / enzyme biologic	2 ml	Other
Subject	JTA-004	Protein / enzyme biologic	4 ml	Other

Indications