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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 (BCD)

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ClinicalTrials.gov Identifier: NCT02410304
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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).


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Xrays Device: Ultrasound (B mode ) Device: Ultrasound (D mode) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment
Actual Study Start Date : October 6, 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Arm C (Clinical)
No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation.
Device: Xrays
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).
Device: Xrays
Clinical evaluation

Device: Ultrasound (B mode )
Arm D (Ultrasound)
No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode.
Device: Ultrasound (D mode)



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]
  2. Assessement of the Xrays evolution at 2 years [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410304


Contacts
Contact: Sandrine Jousse-Joulin, Dr +33298347267 sandrine.jousse-joulin@chu-brest.fr

Locations
France
CHU Angers Recruiting
Angers, France, 49100
Contact: Emmanuel Hoppé, Dr         
Principal Investigator: Emmanuel Hoppé, Dr         
CHRU Brest Recruiting
Brest, France, 29609
Contact: Sandrine Jousse-Joulin, Dr    33298347267    sandrine.jousse-joulin@chu-brest.fr   
Principal Investigator: Sandrine Jousse-Joulin, Dr         
CHU La Roche sur Yon Recruiting
La Roche sur Yon, France, 85925
Contact: Grégoire Cormier, Dr         
Principal Investigator: Grégoire Cormier, Dr         
CH Le Mans Recruiting
Le Mans, France, 72037
Contact: Emmanuel Dernis, Dr         
Principal Investigator: Emmanuel Dernis, Dr         
CH de Lorient Recruiting
Lorient, France, 56322
Contact: José Le Noach, Dr         
Principal Investigator: José Le Noach, Dr         
CHU Nantes Recruiting
Nantes, France, 44093
Contact: Benoît Le Goff, Dr         
Principal Investigator: Benoît Le Goff, Dr         
CHR Orléans Recruiting
Orléans, France, 45067
Contact: Carine Salliot, Dr         
Principal Investigator: Carine Salliot, Dr         
CHU SUD Rennes Recruiting
Rennes, France, 35203
Contact: Aleth Perdriger, Dr         
Principal Investigator: Aleth Perdriger, Dr         
CHU Tours Recruiting
Tours, France, 37044
Contact: Saloua MRAGHNI, Dr         
Principal Investigator: Saloua MRAGHNI, Dr         
CH Vannes Recruiting
Vannes, France, 56017
Contact: Sylvie Hoang, Dr         
Principal Investigator: Sylvie Hoang, Dr         
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02410304     History of Changes
Other Study ID Numbers: BCD RB 14.097
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Keywords provided by University Hospital, Brest:
Rheumatoid arthritis / ultrasonography / synovitis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases