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

NCT ID: NCT02410304

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-06

Study Completion Date

2022-11-25

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid arthritis / ultrasonography / synovitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm C (Clinical)

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

Group Type OTHER

Xrays

Intervention Type DEVICE

Clinical evaluation

Arm B (Clinical + Ultrasound)

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

Group Type OTHER

Xrays

Intervention Type DEVICE

Clinical evaluation

Ultrasound (B mode )

Intervention Type DEVICE

Arm D (Ultrasound)

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

Group Type OTHER

Ultrasound (D mode)

Intervention Type DEVICE

Interventions

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Xrays

Clinical evaluation

Intervention Type DEVICE

Ultrasound (B mode )

Intervention Type DEVICE

Ultrasound (D mode)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status

CHRU Brest

Brest, , France

Site Status

CHU La Roche sur Yon

La Roche-sur-Yon, , France

Site Status

CH Le Mans

Le Mans, , France

Site Status

CH de Lorient

Lorient, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

CHU SUD Rennes

Rennes, , France

Site Status

CHU Tours

Tours, , France

Site Status

CH Vannes

Vannes, , France

Site Status

Countries

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France

Other Identifiers

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BCD 29BRC14.0097

Identifier Type: -

Identifier Source: org_study_id