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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164214
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Inflammatory Rheumatism Psoriatic Arthritis Rheumatoid Arthritis Drug: etanercept Treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?
Study Start Date : September 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: patients PSORIATIC ARTHRITIS
etanercept Treatment
Drug: etanercept Treatment
Active Comparator: patients RHEUMATOID ARTHRITIS
etanercept Treatment
Drug: etanercept Treatment



Primary Outcome Measures :
  1. serum levels of soluble TWEAK [ Time Frame: 42 months ]
    samples blood before and after etanercept Treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164214


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02164214    
Other Study ID Numbers: 2011-002954-29
2011-14 ( Other Identifier: AP HM )
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Rheumatic Fever
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Rheumatic Diseases
Collagen Diseases
Inflammation
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents