Pain Evaluation in Rheumatoid Arthritis

NCT01706029 | Completed

• 1 other identifier: I11013/
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patients pain care

  At day 1

• Correlation

  At day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are selected from those coming to the Department of Rheumatology of each partcipating center.

You may qualify if:

• Adults with RA treated with DMARDs and/or biotherapy,
• Capable of providing written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (7)

CHU Bordeaux- Pellegrin

Bordeaux, 33000, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CHU Hôpital R. Salengro

Lille, 59037, France

Location

Service de Rhumatologie

Limoges, 87000, France

Location

CHU Hôtel-Dieu

Paris, 75004, France

Location

CHU Bois-Guillaume

Rouen, 76230, France

Location

CHU Hautepierre

Strasbourg, 67092, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sampling of blood for dosage of IL-6, IL-17 and IL-33 serum level

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pascale Vergne-Salle, MD

  CHU Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 12, 2017
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (7)