Study of the Functional Status Neutrophils in Rheumatoid Arthritis Patients to Identify New Biomarkers of Response to Anti-TNFalpha Therapy

NCT05802719 | Unknown

• 1 other identifier: RECHMPL22_0150
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional pathophysiological exploratory, cohort, prospective, with a 6-month follow-up study is to characterize phenotypic and functional alterations of PolyMorphonuclear Neutrophils as well as monocytes/macrophages and dendritic cells in blood samples from rheumatoid arthritis patients. Investigators will perform prospective characterization of these myeloid cells before and after treatment to assess how the functional status of PMNs/myeloid cells affects the response to anti-TNFα (tumor necrosis factor alpha) in rheumatoid arthritis. This will identify key immune components potentially involved in the activation and/or recruitment of PolyMorphonuclear Neutrophils (PMN) (and other myeloid cells) that may play a role in the pathogenesis of Rheumatoid Arthritis and may help predict the response to anti-TNFα agents, thus guiding the decision-making of therapeutic strategies.

Conditions

Rheumatoid Arthritis

Keywords

Immunology and Immunotherapy; neutrophils; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• The difference in numbers/functional status of PMN (frequency)

  The difference in numbers/functional status of PMN between baseline and 3 months post-treatment and related to the DAS28 EULAR response. The biomarkers of interest is frequency of PNM after stimulation by inflammatory factors.

  Between baseline and 3 months after the initiation of anti TNFa

• The difference in numbers/functional status of PMN (phenotypic properties/activation)

  The difference in numbers/functional status of PMN between baseline and 3 months post-treatment and related to the DAS28 EULAR response. The biomarkers of interest is phenotypic properties/activation of PMN after stimulation by inflammatory factors.

  Between baseline and 3 months after the initiation of anti TNFa

• The difference in numbers/functional status of PMN (in vitro PMN secretory profile)

  The difference in numbers/functional status of PMN between baseline and 3 months post-treatment and related to the DAS28 EULAR response. The biomarkers of interest is in vitro PMN secretory profile after stimulation by inflammatory factors.

  Between baseline and 3 months after the initiation of anti TNFa

Secondary Outcomes (7)

• To assess how the frequency and activation of myeloid cell subpopulations in the peripheral blood affects the 3-months clinical response to anti-TNFa therapy

  3 months after the initiation of anti TNFa

• To assess how the frequency and activation of myeloid cell subpopulations in the peripheral blood affects the 6-months clinical response to anti-TNFa therapy

  6 months after the initiation of anti TNFa

• To assess if the PMN profile varies between baseline and 3 months after initiation of anti-TNFa therapy

  between baseline and 3 months after initiation of anti-TNFa therapy

• To assess if the PMN profile varies between baseline and 6 months after initiation of anti-TNFa therapy

  between baseline and 6 months after initiation of anti-TNFa therapy

• To assess if the myeloid cell subpopulations varies between baseline and 3 months after initiation of anti-TNFa therapy

  between baseline and 3 months after initiation of anti-TNFa therapy

Study Arms (1)

rheumatoid arthritis patient

EXPERIMENTAL

patient with an active Rheumatoid arthritis and an indication to start an anti-TNFa treatment

Other: Blood sampling

Interventions

Blood sampling OTHER

The procedure consists of collecting 4 additional tubes of blood (20mL) at each visit for research purposes, in order to perform the immunological assays. Blood samples at the inclusion, 3 month and 6 month after initiation of anti-TNF therapy

rheumatoid arthritis patient

Eligibility Criteria

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

You may qualify if:

• Established RA patients fulfilling 2010 ACR/EULAR (American College of Rheumatology / European League Against Rheumatism) definition Active disease (DAS28 score (Disease Activity Score) \> 3.2)
• Indication to start an anti-TNFalpha treatment : adalimumab or etanercept
• years old or older

You may not qualify if:

• Contra-indication to TNF inhibitors (active infections, cancer in the last 5 years, active tuberculosis, hepatitis B or C or HIV positive except for hepatitis B vaccination)
• Severe intercurrent inflammatory disease
• Patient unable to give consent : under guardianship, curators or safeguard of justice;
• Pregnant, parturient or nursing woman.
• Participation in an interventional clinical trial
• Patient refusing to give oral informed consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

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)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christian JORGENSEN, MD PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Christian JORGENSEN, MD PhD

CONTACT

04 67 33 77 98; c-jorgensen@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory pathophysiological cohort study, with a prospective 6-months follow-up

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: September 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)