Pain Evaluation in Rheumatoid Arthritis

NCT ID: NCT01706029

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-12

Brief Summary

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Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .

Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.

So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.

On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.

The aim of this study is:

* to assess the multidimensional origin of the pain in RA patients by means of questionnaires
* to look for a possible correlation between the serum level of cytokines and pain.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults with RA treated with DMARDs and/or biotherapy,
* Capable of providing written consent

Exclusion Criteria

* Patients affected by a painful disease other one than RA,
* Fibromyalgia,
* A malignancy disease,
* An hemopathy,
* Psychiatric disorders or dementia and
* Acute infectious diseases and
* Receive or had received anti-IL6 therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascale Vergne-Salle, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges

Locations

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CHU Bordeaux- Pellegrin

Bordeaux, , France

Site Status

CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

CHU Hôpital R. Salengro

Lille, , France

Site Status

Service de Rhumatologie

Limoges, , France

Site Status

CHU Hôtel-Dieu

Paris, , France

Site Status

CHU Bois-Guillaume

Rouen, , France

Site Status

CHU Hautepierre

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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I11013/

Identifier Type: -

Identifier Source: org_study_id

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