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Pain Evaluation in Rheumatoid Arthritis (Douleur-PR)

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ClinicalTrials.gov Identifier: NCT01706029
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Limoges.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2012
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief 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.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)
Study Start Date : October 2012
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Sampling of blood for dosage of IL-6, IL-17 and IL-33 serum level


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients are selected from those coming to the Department of Rheumatology of each partcipating center.
Criteria

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

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): NCT01706029


Locations
France
CHU Bordeaux- Pellegrin
Bordeaux, France, 33000
CHU Gabriel Montpied
Clermont-Ferrand, France, 63003
CHU Hôpital R. Salengro
Lille, France, 59037
Service de Rhumatologie
Limoges, France, 87000
CHU Hôtel-Dieu
Paris, France, 75004
CHU Bois-Guillaume
Rouen, France, 76230
CHU Hautepierre
Strasbourg, France, 67092
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Pascale Vergne-Salle, MD CHU Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01706029     History of Changes
Other Study ID Numbers: I11013/
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases