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

NCT02531061 | Completed

• 2 other identifiers: 12080922012-A01583-40
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; bDMARDs; biotherapy; remission; erosion

Outcome Measures

Primary Outcomes (1)

• Change in depth of the erosion

  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®).

  baseline from 1 year

Secondary Outcomes (3)

• Change in volume of erosion

  baseline from 1 year

• Change in width of erosion

  baseline from 1 year

• Change in density parameter of bone microarchitecture

  baseline from 1 year

Study Arms (2)

active erosion

EXPERIMENTAL

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

inactive erosion

EXPERIMENTAL

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

Interventions

HR-pQCT DEVICE

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.

Also known as: Xtrem CT scanco

active erosion; inactive erosion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other diagnosis than RA,
• Concomitant treatment with zoledronic acid (Aclasta) or denosumab (Prolia®)
• Refusal of blood collection,
• Pregnancy or breastfeeding women,

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Pfizer: collaborator

Study Sites (2)

HCL - Hôpital EdouarD Herriot

Lyon, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hubert Marotte, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 21, 2015
• Study Start: May 5, 2013
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)