Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?

Phase 3

Completed

• Conditions: Inflammatory Rheumatism; Psoriatic Arthritis; Rheumatoid Arthritis
• Interventions: Drug: etanercept Treatment

• Registration Number: NCT02164214
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation to cell death when it binds to its main receptor, Fn 14. Our team has been the first to describe pro-inflammatory effects of TWEAK during central nervous system inflammation. Various data support the possibility that TWEAK produced by synovial macrophages may contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing anti-TNF autoantibodies referred as "beneficial autoimmunity to pro-inflammatory mediators". In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy. The role of TNF-alpha in the regulation of TWEAK expression remains unclear.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Primary Completion: 2015-03
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• · Group RhPso :

• Fill(Perform) the criteria CASPAR of the Rheumatism psoriasic (Taylor W, on 2006)

• rheumatoid Absence of factor and antibody anti-CCP(anti-post office account) (cyclic citrulline peptide) in the serum

• Indication established to begin a treatment with etanercept

  · Group PR

• Fill(Perform) the criteria of the ACR (American College of Rheumatology) for PR (revised in 1987) (Arneth FC, on 1988)

• Presence of antibody anti-CCP(anti-post office account) in the serum

• Indication established to begin a treatment with etanercept

Exclusion Criteria

• Minors(Miners)
• pregnant or breast-feeding Women
• Adults under guardianship
• Nobody staying in a sanitary or social establishment
• Persons in emergency situation and/or not beneficiaries of a national insurance scheme
• Private persons of freedom
• Arthritis or not labelled polyarthritis
• Contraindication established in the treatment(processing) by etanercept
• PUVAthérapie or cyclosporine or high dose of corticosteroid therapy (except intra-articular infiltration) or other anti-TNF treatment(processing) in two months preceding the inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients PSORIATIC ARTHRITIS	etanercept Treatment	etanercept Treatment
patients RHEUMATOID ARTHRITIS	etanercept Treatment	etanercept Treatment

Primary Outcome Measures

Name	Time	Method
serum levels of soluble TWEAK	42 months	samples blood before and after etanercept Treatment

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France