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

Rheumatoid Arthritis Clinical Trial

Official title:

DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164214
• Other study ID #: 2011-002954-29
• Secondary ID: 2011-14
• Status: Completed
• Phase: Phase 3
• First received: July 4, 2013
• Last updated: September 9, 2015
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Collagen Diseases
• Inflammatory Rheumatism
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis

Intervention

Drug:
• etanercept Treatment

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum levels of soluble TWEAK	samples blood before and after etanercept Treatment	42 months	Yes