Clinical trial NCT02410304: Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
Official title: Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis / ultrasonography / synovitis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Detailed 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.

Eligibility criteria: * Inclusion Criteria:

  * Both gender patients aged 18 -to 80 years old
  * Patients will be eligible if they fulfill ACR/EULAR 2010 rheumatoid arthritis
  * All the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, ARAVA or biologics treatment: Enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion
  * Patients would be able to understand and be agree with the protocole
  * Patients would be able to consent
* Exclusion Criteria:

  * Patient unable to cooperate patient and who refuse to sign consent form
  * Patient unable to understand the study,under administrative supervision or legal guardianship
  * Signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral
  * Scheduled surgery procedure during the study on the estimated joint.
  * Patient non-affiliated to social security
  * Pregnant and nursing mothers

Primary outcomes:
measure: Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the proportion of rheumatoid arthristis in remission according to the method used
timeFrame: at 3 month, 6 month, 9 month and 1 year
measure: Assessement of the Xrays evolution at 2 years
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHRU Brest
city: La Roche sur Yon
country: France
facility: CHU La Roche sur Yon
city: Le Mans
country: France
facility: CH Le Mans
city: Lorient
country: France
facility: CH de Lorient
city: Nantes
country: France
facility: CHU Nantes
city: Orléans
country: France
facility: CHR Orléans
city: Rennes
country: France
facility: CHU SUD Rennes
city: Tours
country: France
facility: CHU Tours
city: Vannes
country: France
facility: CH Vannes
Study officials:
References: