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Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy

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ClinicalTrials.gov Identifier: NCT02531061
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some criteria were already proposed and the last one was proposed in 2011.

All these criteria integrated only clinical criteria without imaging assessment. In this context, ultrasound joint is daily performed without definition of remission. A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage. A definition of remission in RA could include erosions regression in subchondral bone (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)).

The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion.

Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage (progression of radiographic lesions). Recent data showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is a new technique emerging for bone erosions assessment in RA. Erosions size and volume could be reduced with anti-TNF, but with a large interindividual variability. There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Device: HR-pQCT

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy
Actual Study Start Date : May 5, 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: active erosion
HR-pQCT for measure bone parameters in "active erosion" group. The "active erosion" group will be defined by grades 2 and 3, ie by the presence of Doppler signals confluence in less than 50% of the synovial surface (grade 2) and in over 50% of the surface synovial for grade 3
Device: HR-pQCT

The Xtrem CT scanco device is a HR-pQCT. It was initially used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body.

For the study, the device will be used to measure changes in erosion at the 2nd or 3rd metacarpal head. Only the patient's hand will be in contact with the medical device, the acquisition time will be 3 minutes.

Other Name: Xtrem CT scanco
Experimental: inactive erosion
HR-pQCT for measure bone parameters in "active erosion" group. The "inactive erosion" group will be defined by grades 0 and 1, ie the absence of Doppler signal for grade 0 and the presence of some non confluence Doppler signals for the grade 1
Device: HR-pQCT

The Xtrem CT scanco device is a HR-pQCT. It was initially used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body.

For the study, the device will be used to measure changes in erosion at the 2nd or 3rd metacarpal head. Only the patient's hand will be in contact with the medical device, the acquisition time will be 3 minutes.

Other Name: Xtrem CT scanco


Outcome Measures

Primary Outcome Measures :
  1. Change in depth of the erosion [ Time Frame: baseline from 1 year ]
    compare the change in the depth of the erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).


Secondary Outcome Measures :
  1. Change in volume of erosion [ Time Frame: baseline from 1 year ]
    compare the change in volume of erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).

  2. Change in width of erosion [ Time Frame: baseline from 1 year ]
    compare the change in width of erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).

  3. Change in density parameter of bone microarchitecture [ Time Frame: baseline from 1 year ]
    compare the change in density parameter of bone microarchitecture of erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®). Density parameter of bone microarchitecture is a composite outcome : Total mineral volumetric density (mg/ccm HA), Trabéculaire mineral volumetric density (mg/ccm HA), Cortical mineral volumetric density (mg/ccm HA), Trabecular Number (1/mm), Trabecular thickness (mm), Trabecular Separation (mm), Mean distance between trabeculae (mm), Presence of new erosions and volume


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Initial medical examination performed,
  • RA diagnosis according to the criteria of the ACR / EULAR 2010
  • Low or moderate disease activity with a DAS28 ≤ 4 since at least for 6 months
  • Patients with bDMARDs (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, ou Orencia®) since at least 6 months and no change planned by the investigator,
  • Patient with at least one erosion on the head of the 2nd or 3rd metacarpal right or left,
  • Stable corticosteroids dose since at least 3 months less than or equal to 10 mg of prednisone equivalent,
  • Medical care and monitoring in the rheumatology department of the CHU of Saint-Etienne or the Edouard Herriot Hospital in Lyon,
  • written consent of patient

Exclusion Criteria:

  • Other diagnosis than RA,
  • Intravenous or intra-articular injection at the 2nd or 3rd metacarpophalangeal left or right during the 3 months prior to inclusion,
  • Surgery provided at the 2nd or 3rd metacarpophalangeal right or left within a year of inclusion,
  • Concomitant treatment with zoledronic acid (Aclasta) or denosumab (Prolia®)
  • Refusal of blood collection,
  • Pregnancy or breastfeeding women,
Contacts and Locations

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): NCT02531061


Contacts
Contact: Hubert Marotte, PhD (0)4 77 12 76 43 ext +33 hubert.marotte@chu-st-etienne.fr
Contact: Florence Rancon, CRA (0)477120284 ext +33 florence.rancon@chu-st-etienne.fr

Locations
France
HCL - Hôpital EdouarD Herriot Not yet recruiting
Lyon, France
Contact: Roland Chapurlat, PhD         
Principal Investigator: Roland Chapurlat, PhD         
Sub-Investigator: Déborah Gensburger, MD         
Sub-Investigator: Thibaut Rolland, MD         
Sub-Investigator: Stéphanie Boutroy, MD         
Sub-Investigator: Pierre Miossec, MD         
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Hubert Marotte, PhD    (0)4 77 12 76 43 ext +33    hubert.marotte@chu-st-etienne.fr   
Principal Investigator: Hubert Marotte, PhD         
Sub-Investigator: Adamah Amouzougan, MD         
Sub-Investigator: Béatrice Pallot-Prades, MD         
Sub-Investigator: Elodie Constant, MD         
Sub-Investigator: Thierry Thomas, MD         
Sub-Investigator: Philippe Collet, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Pfizer
Investigators
Principal Investigator: Hubert Marotte, PhD CHU Saint-Etienne
More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02531061     History of Changes
Other Study ID Numbers: 1208092
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Rheumatoid Arthritis
bDMARDs
biotherapy
remission
erosion

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