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Completed

NCT Number: NCT01706029

Pain Evaluation in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux- Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of the pain

    Time frame: At day 1

    Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria

Secondary outcomes

  1. Patients pain care

    Time frame: At day 1

    Estimate the satisfaction of the patients towards the coverage (care) of their pain by means of VAS and verbal scale of satisfaction

  2. Correlation

    Time frame: At day 1

    Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)

Acronym: Douleur-PR

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Oct 15, 2012
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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