NCT03280797

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 24, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

3.2 years

First QC Date

September 11, 2017

Last Update Submit

January 24, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Dosage of cytokines between groups

    Concentration measured by ELISA and flow cytometry

    Day 0

Secondary Outcomes (1)

  • Creation of biobank

    Day 0

Study Arms (2)

Control

OTHER
Procedure: Blood sample

Rheumatoid arthritis patients

OTHER
Procedure: Blood sample

Interventions

Blood samplePROCEDURE

2ml blood taken into TruCulture tube

ControlRheumatoid arthritis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

November 24, 2017

Primary Completion

February 8, 2021

Study Completion

January 12, 2022

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

FR(2)