Pain Evaluation in Rheumatoid Arthritis (Douleur-PR)
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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) |
- 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
- 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 2014 |
| Estimated Primary Completion Date: | October 2013 (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 |
Patients are selected from those coming to the Department of Rheumatology of each partcipating center.
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| Contact: Pascale Vergne-Salle, MD | 0555058831 | pascale.vergne-salle@chu-limoges.fr |
| 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 | |
| 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: | February 27, 2013 |
| 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 May 19, 2013