Back to resultsA New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis (TNF-RS-PR)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Reverse Signaling, Anti-TNF
Eligibility Criteria
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
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
patients with good response to anti-TNF had a blood test
patients with moderate or non-response to anti-TNF had a blood test
Outcomes
Primary Outcome Measures
CD36 expression
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
Monocytes
Phenotype of freshly isolated monocytes before cell-culture
Nuclear translocation of NRF2
Nuclear translocation of Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induced by anti-TNF ex vivo
Full Information
NCT ID
NCT03216928
First Posted
June 12, 2017
Last Updated
July 28, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03216928
Brief Title
A New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis
Acronym
TNF-RS-PR
Official Title
Pilot Study Investigating a New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Reverse Signaling, Anti-TNF
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
patients with good response to anti-TNF had a blood test
Arm Title
Group 2
Arm Type
Experimental
Arm Description
patients with moderate or non-response to anti-TNF had a blood test
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test
Primary Outcome Measure Information:
Title
CD36 expression
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Monocytes
Description
Phenotype of freshly isolated monocytes before cell-culture
Time Frame
Day 0
Title
Nuclear translocation of NRF2
Description
Nuclear translocation of Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induced by anti-TNF ex vivo
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Frédéric Boyer, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis
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