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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Inflammatory Rheumatism
• Intervention / Treatment: Drug: etanercept Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients PSORIATIC ARTHRITIS; etanercept Treatment	Drug: etanercept Treatment
Active Comparator: patients RHEUMATOID ARTHRITIS; etanercept Treatment	Drug: etanercept Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum levels of soluble TWEAK	samples blood before and after etanercept Treatment	42 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 4, 2013
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Rheumatoid; Inflammation; Arthritis, Psoriatic; Rheumatic Diseases; Collagen Diseases; Rheumatic Fever; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 2011-002954-29; 2011-14 (AP HM)