A New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Diagnostic Test: Blood test

• Registration Number: NCT03216928
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Blood test	patients with good response to anti-TNF had a blood test
Group 2	Blood test	patients with moderate or non-response to anti-TNF had a blood test

Primary Outcome Measures

Name	Time	Method
CD36 expression	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

Name	Time	Method
Monocytes	Day 0	Phenotype of freshly isolated monocytes before cell-culture
Nuclear translocation of NRF2	Day 0	Nuclear translocation of Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induced by anti-TNF ex vivo

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France