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

NCT02410304 | Completed

• 1 other identifier: BCD 29BRC14.0097
• Study Type: interventional
• Target: 561
• Locations: 1 country
• Sites: 10

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).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis / ultrasonography / synovitis

Outcome Measures

Primary Outcomes (1)

• Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.

  The primary outcome 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 rheumatoid arthritis patients (ACR/EULAR 2010) according to remission defined by modified SDAI in order to evaluate in all cases the same number of joints \[Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and practitioner with VAS, and PCR ≤ 3.3mg/l\] (mode C), with 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) or an ultrasound approach (remission défined 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).

  1 year

Secondary Outcomes (2)

• Evaluation of the proportion of rheumatoid arthristis in remission according to the method used

  at 3 month, 6 month, 9 month and 1 year

• Assessement of the Xrays evolution at 2 years

  2 years

Study Arms (3)

Arm C (Clinical)

OTHER

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

Device: Xrays

Arm B (Clinical + Ultrasound)

OTHER

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

Device: Xrays; Device: Ultrasound (B mode )

Arm D (Ultrasound)

OTHER

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

Device: Ultrasound (D mode)

Interventions

Xrays DEVICE

Clinical evaluation

Arm B (Clinical + Ultrasound); Arm C (Clinical)

Ultrasound (B mode ) DEVICE

Arm B (Clinical + Ultrasound)

Ultrasound (D mode) DEVICE

Arm D (Ultrasound)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both gender patients aged 18 -to 80 years old
• Patients will be eligible if they fulfill ACR/EULAR 2010 rheumatoid arthritis
• Patients would be able to understand and be agree with the protocole
• Patients would be able to consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (10)

CHU Angers

Angers, 49100, France

Location

CHRU Brest

Brest, 29609, France

Location

CHU La Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

CH Le Mans

Le Mans, 72037, France

Location

CH de Lorient

Lorient, 56322, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHR Orléans

Orléans, 45067, France

Location

CHU SUD Rennes

Rennes, 35203, France

Location

CHU Tours

Tours, 37044, France

Location

CH Vannes

Vannes, 56017, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Synovitis

Interventions

Diagnostic Imaging; Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 7, 2015
• Study Start: October 6, 2015
• Primary Completion: November 1, 2021
• Study Completion: November 25, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

FR (10)