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

Primary Purpose

Inflammatory Rheumatism, Psoriatic Arthritis, Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
etanercept Treatment
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Rheumatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients PSORIATIC ARTHRITIS

patients RHEUMATOID ARTHRITIS

Arm Description

etanercept Treatment

etanercept Treatment

Outcomes

Primary Outcome Measures

serum levels of soluble TWEAK
samples blood before and after etanercept Treatment

Secondary Outcome Measures

Full Information

First Posted
July 4, 2013
Last Updated
September 9, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02164214
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Rheumatism, Psoriatic Arthritis, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients PSORIATIC ARTHRITIS
Arm Type
Experimental
Arm Description
etanercept Treatment
Arm Title
patients RHEUMATOID ARTHRITIS
Arm Type
Active Comparator
Arm Description
etanercept Treatment
Intervention Type
Drug
Intervention Name(s)
etanercept Treatment
Primary Outcome Measure Information:
Title
serum levels of soluble TWEAK
Description
samples blood before and after etanercept Treatment
Time Frame
42 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27338143
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.
Results Reference
derived

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

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