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

Rheumatoid Arthritis Clinical Trial

— BCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410304
• Other study ID #: BCD 29BRC14.0097
• Status: Completed
• Phase: N/A
• Start date: October 6, 2015
• Est. completion date: November 25, 2022

Study information

• Verified date: December 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: November 25, 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Xrays
Clinical evaluation
• Ultrasound (B mode )

• Ultrasound (D mode)

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHRU Brest	Brest
France	CHU La Roche sur Yon	La Roche sur Yon
France	CH Le Mans	Le Mans
France	CH de Lorient	Lorient
France	CHU Nantes	Nantes
France	CHR Orléans	Orléans
France	CHU SUD Rennes	Rennes
France	CHU Tours	Tours
France	CH Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the proportion of rheumatoid arthristis in remission according to the method used		at 3 month, 6 month, 9 month and 1 year
Secondary	Assessement of the Xrays evolution at 2 years		2 years