NCT02164214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
12 months until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

3.5 years

First QC Date

July 4, 2013

Last Update Submit

September 9, 2015

Conditions

Inflammatory RheumatismPsoriatic ArthritisRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • serum levels of soluble TWEAK

    samples blood before and after etanercept Treatment

    42 months

Study Arms (2)

patients PSORIATIC ARTHRITIS

EXPERIMENTAL

etanercept Treatment

Drug: etanercept Treatment

patients RHEUMATOID ARTHRITIS

ACTIVE COMPARATOR

etanercept Treatment

Drug: etanercept Treatment

Interventions

etanercept TreatmentDRUG
patients PSORIATIC ARTHRITISpatients RHEUMATOID ARTHRITIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • 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.

    PMID: 27338143DERIVED

MeSH Terms

Conditions

Rheumatic FeverArthritis, PsoriaticArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

June 16, 2014

Study Start

September 1, 2011

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

FR(1)