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A New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis (TNF-RS-PR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03216928
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : September 21, 2018
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Blood test in Rheumatoid Arthritis (RA) patients with good response to anti-Tumor Necrosis Factor (anti-TNF) and in patients with moderate or non-response will be done in the month following the evaluation of clinical response to therapy. Isolation of mononuclear cells and purification of monocyte by negative selection. Cell culture of monocyte in presence or not of anti-TNF for 24 hours and analyze of CD36 (cluster of differentiation antigen 36) expression (principal outcome). For secondary outcomes analyze monocyte phenotype, NRF2 nuclear translocation, and clinical data of patients.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Diagnostic Test: Blood test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study Investigating a New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1
patients with good response to anti-TNF had a blood test
Diagnostic Test: Blood test
Experimental: Group 2
patients with moderate or non-response to anti-TNF had a blood test
Diagnostic Test: Blood test

Primary Outcome Measures :
  1. CD36 expression [ Time Frame: Day 0 ]
    Percentage of increase of CD36 (cluster of differentiation 36) expression induced by anti-TNF ex vivo after 24h of cell culture in two groups of human monocytes: monocytes providing of RA patients good responder to anti-TNF in one hand, and moderate or non-responder in the other hand.

Secondary Outcome Measures :
  1. Monocytes [ Time Frame: Day 0 ]
    Phenotype of freshly isolated monocytes before cell-culture

  2. Nuclear translocation of NRF2 [ Time Frame: Day 0 ]
    Nuclear translocation of Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induced by anti-TNF ex vivo

Information from the National Library of Medicine

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

Inclusion Criteria:

  • RA defined according to the American College of Rheumatology (ACR) 2010 criteria,
  • treated by anti-TNF + methotrexate, good responders in in one arm, and moderate or non-responders in the other arm according to EULAR (European Ligue Against Rheumatism) response criteria after three months of treatment

Exclusion Criteria:

  • contra-indication to anti-TNF
  • corticosteroid more than 10mg by a day equivalent prednisone,
  • modification of DMARD (disease-modifying antirheumatic drugs) in the last three months
  • comprehension trouble
  • Factors modifying CD36 -cluster of differentiation antigen 36- expression as diabetes mellitus, kidney disease, HIV

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 identifier (NCT number): NCT03216928

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Contact: Jean-Frédéric Boyer, MD 33-683716727

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University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Jean-Frédéric Boyer, MD         
Sponsors and Collaborators
University Hospital, Toulouse
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Principal Investigator: Jean-Frédéric Boyer, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse Identifier: NCT03216928     History of Changes
Other Study ID Numbers: 15 7735 02
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Reverse Signaling
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases