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

January 24, 2022 updated by: Centre Hospitalier Universitaire de Nīmes
This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Nîmes, France, 30029
        • CHU Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Procedure: Blood sample
2ml blood taken into TruCulture tube
Other: Rheumatoid arthritis patients
Procedure: Blood sample
2ml blood taken into TruCulture tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosage of cytokines between groups
Time Frame: Day 0
Concentration measured by ELISA and flow cytometry
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of biobank
Time Frame: Day 0
Storage of blood samples
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2017

Primary Completion (Actual)

February 8, 2021

Study Completion (Actual)

January 12, 2022

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2016/TAT01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe