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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Device: Xrays; Device: Ultrasound (B mode ); Device: Ultrasound (D mode)

Study type: Interventional

Funder types: Other

Identifiers

NCT02410304

BCD 29BRC14.0097

Details and patient eligibility

About

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).

Full 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.

Enrollment: 561 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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561 participants in 3 patient groups

Arm C (Clinical)

Other group

Description:

No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation.

Treatment:

Device: Xrays

Arm B (Clinical + Ultrasound)

Other group

Description:

No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode).

Treatment:

Device: Xrays

Device: Ultrasound (B mode )

Arm D (Ultrasound)

Other group

Description:

No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode.

Treatment:

Device: Ultrasound (D mode)