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

Pilot Study Investigating a New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216928

Acronym

TNF-RS-PR

Enrollment

Registered

2017-07-13

Start date

2017-01-31

Completion date

2020-03-12

Last updated

2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Reverse Signaling, Anti-TNF

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.

Interventions

DIAGNOSTIC_TESTBlood test

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026