Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

Rheumatoid Arthritis Clinical Trial

— IL-MAI  

Official title:

Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280797
• Other study ID #: LOCAL/2016/TAT01
• Status: Completed
• Phase: N/A
• Start date: November 24, 2017
• Est. completion date: January 12, 2022

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 12, 2022
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given their free and informed consent and signed the consent form

• The patient must be a member or beneficiary of a health insurance plan

• Patient is at least 18 years old

• Subjects included as patients have rheumatoid polyarthritis according to ACR EULA 2010, DAS28>3.2 criteria

• Subjects included as controls are healthy volunteers who have no overexpression of cytokines

Exclusion Criteria:

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study

• The subject refuses to sign the consent

• It is impossible to give the subject informed information

• The patient has had at least 3 months of specific treatment that can potentially impact cytokine profile

Related Conditions & MeSH terms

• Autoimmune Diseases
• Immune System Diseases
• Rheumatoid Arthritis

Intervention

Procedure:
• Blood sample
2ml blood taken into TruCulture tube

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of cytokines between groups	Concentration measured by ELISA and flow cytometry	Day 0
Secondary	Creation of biobank	Storage of blood samples	Day 0