Rheumatoid Arthritis Clinical Trial
Official title:
Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy
Verified date | October 2018 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 29, 2017 |
Est. primary completion date | November 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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, |
Country | Name | City | State |
---|---|---|---|
France | HCL - Hôpital EdouarD Herriot | Lyon | |
France | CHU Saint-Etienne | Saint-Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in volume of erosion | 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®). | baseline from 1 year | |
Secondary | Change in width of erosion | 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®). | baseline from 1 year | |
Secondary | Change in density parameter of bone microarchitecture | 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 | baseline from 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |