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

NCT ID: NCT03216928

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-03-12

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

patients with good response to anti-TNF had a blood test

Group Type EXPERIMENTAL

Blood test

Intervention Type DIAGNOSTIC_TEST

Group 2

patients with moderate or non-response to anti-TNF had a blood test

Group Type EXPERIMENTAL

Blood test

Intervention Type DIAGNOSTIC_TEST

Interventions

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Blood test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Frédéric Boyer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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15 7735 02

Identifier Type: -

Identifier Source: org_study_id

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