Evaluation of The Efficacy And Safety of Intra-Articular Etanercept in Patients With Refractory Knee Joint Synovitis

Summary

To assess the therapeutic efficacy, of the clinical response of intraarticular (IA) etanercept (E) 12.5 mg or placebo (P: NaCl) injections into single knee arthritic joint of patients with refractory knee joint synovitis (KJS), administered once every two week, for eight weeks, with cross over after 2 weeks, in two groups of randomly assigned patients, for whom traditional systemic disease-modifying antirheumatic drugs (DMARDs) is insufficient or inappropriate. The primary outcome measure is the Thompson articular index of KJS disease activity.

Timeline

Start

2005-04

Primary completion

2007-12

Completion

2007-12

Publications

• Fiocco U, Sfriso P, Oliviero F, Lunardi F, Calabrese F, Scagliori E, Cozzi L, Di Maggio A, Nardacchione R, Molena B, Felicetti M, Gazzola K, Stramare R, Rubaltelli L, Accordi B, Costa L, Roux-Lombard P, Punzi L, Dayer JM. Blockade of intra-articular TNF in peripheral spondyloarthritis: its relevance to clinical scores, quantitative imaging and synovial fluid and synovial tissue biomarkers. Joint Bone Spine. 2013 Mar;80(2):165-70. doi: 10.1016/j.jbspin.2012.06.016. Epub 2012 Aug 3.
• Fiocco U, Oliviero F, Sfriso P, Calabrese F, Lunardi F, Scagliori E, Rubaltelli L, Stramare R, Di Maggio A, Nardacchione R, Cozzi L, Molena B, Felicetti M, Gazzola K, Lo Nigro A, Accordi B, Roux-Lombard P, Dayer JM, Punzi L. Synovial biomarkers in psoriatic arthritis. J Rheumatol Suppl. 2012 Jul;89:61-4. doi: 10.3899/jrheum.120246.

Drugs

Indications