Rheumatoid Arthritis Clinical Trial
— Douleur-PROfficial title:
Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)
NCT number | NCT01706029 |
Other study ID # | I11013/ |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | December 12, 2017 |
Verified date | January 2019 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 12, 2017 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Bordeaux- Pellegrin | Bordeaux | |
France | CHU Gabriel Montpied | Clermont-Ferrand | |
France | CHU Hôpital R. Salengro | Lille | |
France | Service de Rhumatologie | Limoges | |
France | CHU Hôtel-Dieu | Paris | |
France | CHU Bois-Guillaume | Rouen | |
France | CHU Hautepierre | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the pain | Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria | At day 1 | |
Secondary | Patients pain care | Estimate the satisfaction of the patients towards the coverage (care) of their pain by means of VAS and verbal scale of satisfaction | At day 1 | |
Secondary | Correlation | Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire | At day 1 |
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