Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment

  • STATUS
    Not Recruiting
  • End date
    Oct 23, 2022
  • participants needed
    561
  • sponsor
    University Hospital, Brest
Updated on 23 May 2022
remission
methotrexate
rituximab
hydroxychloroquine
remicade
enbrel
humira
abatacept
cimzia
tocilizumab

Summary

This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.

It could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).

Description

The aim of this study is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of patients affected by rheumatoid arthritis (ACR/EULAR 2010). The first approach is the assessment of remission defined by modified SDAI in order to evaluate in all cases the same number of joints [Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and and practitioner with VAS, and PCR 3.3mg/l] (mode C). The second one is a combined approach: clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B). The last one is an ultrasound approach (remission defined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).

This trial is a National randomized multicentre trial that compares three modes of follow to adjust the therapeutic adaptation in Rheumatoid Artritis.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric), Rheumatoid Arthritis (Pediatric)
Treatment Xrays, Xrays, Ultrasound (B mode ), Ultrasound (D mode)
Clinical Study IdentifierNCT02410304
SponsorUniversity Hospital, Brest
Last Modified on23 May 2022

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