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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 3

Conditions: Inflammatory Rheumatism; Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Drug: etanercept Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02164214

2011-002954-29

2011-14

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

patients PSORIATIC ARTHRITIS

Experimental group

Description:

etanercept Treatment

Treatment:

Drug: etanercept Treatment

patients RHEUMATOID ARTHRITIS

Active Comparator group

Description:

etanercept Treatment

Treatment:

Drug: etanercept Treatment