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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280797
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Procedure: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : November 24, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control Procedure: Blood sample
2ml blood taken into TruCulture tube

Rheumatoid arthritis patients Procedure: Blood sample
2ml blood taken into TruCulture tube




Primary Outcome Measures :
  1. Dosage of cytokines between groups [ Time Frame: Day 0 ]
    Concentration measured by ELISA and flow cytometry


Secondary Outcome Measures :
  1. Creation of biobank [ Time Frame: Day 0 ]
    Storage of blood samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280797


Locations
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France
CHU de Montpellier Not yet recruiting
Montpellier, France, 34295
Contact: Christian Jorgensen, MD       rhumato-jorgensen@chu-montpellier.fr   
Principal Investigator: Christian Jorgensen         
CHU Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Tu-Anh Tran, MD         
Sub-Investigator: Anne Filleron, MD         
Sub-Investigator: Cécile Gaujoux-Viala, MD         
Sub-Investigator: Françoise F Barchechath, MD         
Sub-Investigator: Anaiz Nutz, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03280797    
Other Study ID Numbers: LOCAL/2016/TAT01
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases