Clinical trial NCT02164214: Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?
Official title: DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Rheumatism
Psoriatic Arthritis
Rheumatoid Arthritis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: serum levels of soluble TWEAK
timeFrame: 42 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
citation: Guis S, Berbis P, Stephan D, Bertin D, Amatore F, Balandraud N, Lesavre N, Desplat-Jego S. TWEAK-binding autoantibodies are generated during psoriatic arthritis and are not influenced by anti-TNF therapy. J Transl Med. 2016 Jun 23;14(1):185. doi: 10.1186/s12967-016-0923-8.