Pain Evaluation in Rheumatoid Arthritis (Douleur-PR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01706029
First received: October 10, 2012
Last updated: March 8, 2015
Last verified: March 2015
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Evaluation of the pain [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria


Secondary Outcome Measures:
  • Patients pain care [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    Estimate the satisfaction of the patients towards the coverage (care) of their pain by means of VAS and verbal scale of satisfaction

  • Correlation [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01706029     History of Changes
Other Study ID Numbers: I11013/
Study First Received: October 10, 2012
Last Updated: March 8, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 01, 2015