Rheumatoid ArthritisBCDNCT02410304
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
A study testing Xrays, Ultrasound (B mode ) and Ultrasound (D mode) in people with Rheumatoid Arthritis, run by University Hospital, Brest at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Xrays, Ultrasound (B mode ) and Ultrasound (D mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 10 sitesFrance
- Study dates
- 6 Oct 2015to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Angers
Angers, 49100
CHRU Brest
Brest, 29609
CHU La Roche sur Yon
La Roche-sur-Yon, 85925
CH Le Mans
Le Mans, 72037
CH de Lorient
Lorient, 56322
CHU Nantes
Nantes, 44093
CHR Orléans
Orléans, 45067
CHU SUD Rennes
Rennes, 35203
CHU Tours
Tours, 37044
CH Vannes
Vannes, 56017
About this study
Official title: Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment
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).
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Xrays, Ultrasound (B mode ), Ultrasound (D mode)
- Keywords
- Rheumatoid arthritis / ultrasonography / synovitis
- Medical subject headings
- Arthritis, Rheumatoid, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XraysDevice
Clinical evaluation
Ultrasound (B mode )Device
Ultrasound (D mode)Device
| Study group | Role | What they receive |
|---|---|---|
| Arm C (Clinical) | Other | No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation. Receives: 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). Receives: 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. Receives: Device: Ultrasound (D mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (2)
Evaluation of the proportion of rheumatoid arthristis in remission according to the method used
Measured: at 3 month, 6 month, 9 month and 1 year
Assessement of the Xrays evolution at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start6 Oct 2015
- Primary completionNov 2021
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410304
- Sponsor's protocol ID
- BCD 29BRC14.0097
- Acronym
- BCD
- Status last verified
- Dec 2023
- First submitted
- 2 Apr 2015
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment
- ClinicalTrials.gov ID
- NCT02410304
- Acronym / sponsor ID
- BCD / BCD 29BRC14.0097
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis / ultrasonography / synovitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm C (Clinical) | Other | Device: XraysNo drug and no placebo were used in this arm. Patients were followed only by clinical évaluation. |
| Arm B (Clinical + Ultrasound) | Other | Device: Xrays, Device: Ultrasound (B mode )No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode). |
| Arm D (Ultrasound) | Other | Device: Ultrasound (D mode)No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XraysClinical evaluation | Device | Arm B (Clinical + Ultrasound), Arm C (Clinical) |
| Ultrasound (B mode ) | Device | Arm B (Clinical + Ultrasound) |
| Ultrasound (D mode) | Device | Arm D (Ultrasound) |
Primary outcome
Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.
Time frame: 1 year
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).
2 secondary outcomes
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
Assessement of the Xrays evolution at 2 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xrays, Ultrasound (B mode ) and Ultrasound (D mode) in people with Rheumatoid Arthritis, run by University Hospital, Brest at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.