Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment (BCD)
Primary Purpose
Rheumatoid Arthritis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Xrays
Ultrasound (B mode )
Ultrasound (D mode)
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis / ultrasonography / synovitis
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
Sites / Locations
- CHU Angers
- CHRU Brest
- CHU La Roche sur Yon
- CH Le Mans
- CH de Lorient
- CHU Nantes
- CHR Orléans
- CHU SUD Rennes
- CHU Tours
- CH Vannes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Arm C (Clinical)
Arm B (Clinical + Ultrasound)
Arm D (Ultrasound)
Arm Description
No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation.
No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode).
No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Evaluation of the proportion of rheumatoid arthristis in remission according to the method used
Assessement of the Xrays evolution at 2 years
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02410304
Brief Title
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2015 (Actual)
Primary Completion Date
November 2021 (Actual)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis / ultrasonography / synovitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
561 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm C (Clinical)
Arm Type
Other
Arm Description
No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation.
Arm Title
Arm B (Clinical + Ultrasound)
Arm Type
Other
Arm Description
No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode).
Arm Title
Arm D (Ultrasound)
Arm Type
Other
Arm Description
No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode.
Intervention Type
Device
Intervention Name(s)
Xrays
Intervention Description
Clinical evaluation
Intervention Type
Device
Intervention Name(s)
Ultrasound (B mode )
Intervention Type
Device
Intervention Name(s)
Ultrasound (D mode)
Primary Outcome Measure Information:
Title
Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of the proportion of rheumatoid arthristis in remission according to the method used
Time Frame
at 3 month, 6 month, 9 month and 1 year
Title
Assessement of the Xrays evolution at 2 years
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU La Roche sur Yon
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
CH de Lorient
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
CHU SUD Rennes
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CH Vannes
City
Vannes
ZIP/Postal Code
56017
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
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