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

NCT03216928 | Completed

• 1 other identifier: 15 7735 02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Reverse Signaling; Anti-TNF

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0

Secondary Outcomes (2)

• Monocytes

  Day 0

• Nuclear translocation of NRF2

  Day 0

Study Arms (2)

Group 1

EXPERIMENTAL

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

Diagnostic Test: Blood test

Group 2

EXPERIMENTAL

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

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jean-Frédéric Boyer, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: July 13, 2017
• Study Start: January 1, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)