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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)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Montpellier
  • CHU Nimes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control

Rheumatoid arthritis patients

Arm Description

Outcomes

Primary Outcome Measures

Dosage of cytokines between groups
Concentration measured by ELISA and flow cytometry

Secondary Outcome Measures

Creation of biobank
Storage of blood samples

Full Information

First Posted
September 11, 2017
Last Updated
January 24, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03280797
Brief Title
Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Title
Rheumatoid arthritis patients
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
2ml blood taken into TruCulture tube
Primary Outcome Measure Information:
Title
Dosage of cytokines between groups
Description
Concentration measured by ELISA and flow cytometry
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Creation of biobank
Description
Storage of blood samples
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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