Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor University Hospital, Limoges
Start date October 2012
End date December 2014
Trial size 300 participants
Trial identifier NCT01706029, I11013/

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Evaluation of the pain
time frame: At day 1

Secondary Outcomes

Measure
Patients pain care
time frame: At day 1
Correlation
time frame: At day 1

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)
Principal investigator Pascale Vergne-Salle, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University Hospital, Limoges.