Pain Evaluation in Rheumatoid Arthritis (Douleur-PR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01706029
First received: October 10, 2012
Last updated: July 14, 2014
Last verified: July 2014
  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: March 2015
Estimated Primary Completion Date: October 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

Contacts
Contact: Pascale Vergne-Salle, MD 0555058831 pascale.vergne-salle@chu-limoges.fr

Locations
France
CHU Bordeaux- Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Christophe Richez, MD    0556795556    Christophe.richez@chu-bordeaux.fr   
Principal Investigator: Christophe Richez, MD         
CHU Gabriel Montpied Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: MS Soubrier, MD    04 73 75 14 88    msoubrier@chu-clermontferrand.fr   
Principal Investigator: MS Soubrier, MD         
CHU Hôpital R. Salengro Recruiting
Lille, France, 59037
Contact: RM Flipo, MD    03 20 44 60 62    rmflipo@chru-lille.fr   
Principal Investigator: RM Flipo, MD         
Service de Rhumatologie Recruiting
Limoges, France, 87000
Contact: Pascale Vergne-Salle, MD    05 55 05 64 69    pascale.vergne-salle@chu-limoges.fr   
Principal Investigator: Pascale Vergne-Salle, MD         
CHU Hôtel-Dieu Not yet recruiting
Paris, France, 75004
Contact: Serge Perrot, MD    01 42 34 84 49    serge.perrot@htd.aphp.fr   
Principal Investigator: Serge Perrot, MD         
CHU Bois-Guillaume Recruiting
Rouen, France, 76230
Contact: Olivier Vittecoq, MD    02 32 88 90 19    olivier.vittecoq@chu-rouen.fr   
Principal Investigator: Olivier vittecoq, MD         
CHU Hautepierre Recruiting
Strasbourg, France, 67092
Contact: Jean Sibilia, MD    03 88 12 79 55    jean.sibilia@wanadoo.fr   
Principal Investigator: Jean Sibilia, MD         
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: July 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 20, 2014