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Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission (SONORE)

Primary Purpose

Rheumatoid Arthritis in Remission

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Articular ultrasound
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rheumatoid Arthritis in Remission focused on measuring Rheumatoid arthritis, Articular ultrasound, Synovitis, Relapse risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
  • Patient treated by DMARDs (disease-modifying antirheumatic drug)
  • Patient in confirmed remission for less than 6 months

Exclusion Criteria:

  • Patient participating simultaneously in another clinical study with blind treatment
  • Patient participating simultaneously in another clinical study involving decreasing of drug dose
  • Patient in post clinical study exclusion period
  • patients subject to legal protection measures
  • Patient unable to read French
  • Pregnant or breast-feeding women
  • patient treated with Rituximab

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study patient

Arm Description

Articular ultrasound at each study follow-up

Outcomes

Primary Outcome Measures

1 year pejorative evolution
Number of patient with a clinical relapse

Secondary Outcome Measures

Structural progression
Number of patient with a structural progression of the illness
RA (Rheumatoid Arthritis) remission duration
Evaluation of the remission duration (patient in both clinical and ultrasound remission)
RA ultrasound remission duration
Evaluation of the ultrasound remission duration
RA clinical remission duration
Evaluation of the clinical remission duration
Clinical relapse at one year
Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data
Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)
identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission
Radiographic progression at 1 year
Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis
Intra-observator reproductibility
Evaluating the intra-observer reliability for US synovitis through study completion

Full Information

First Posted
November 19, 2015
Last Updated
June 7, 2018
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02618954
Brief Title
Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission
Acronym
SONORE
Official Title
Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA). At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years. However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care. The investigator propose to conduct a prospective, bi-center, non randomized study.
Detailed Description
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month. The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis in Remission
Keywords
Rheumatoid arthritis, Articular ultrasound, Synovitis, Relapse risk

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study patient
Arm Type
Other
Arm Description
Articular ultrasound at each study follow-up
Intervention Type
Other
Intervention Name(s)
Articular ultrasound
Intervention Description
(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint
Primary Outcome Measure Information:
Title
1 year pejorative evolution
Description
Number of patient with a clinical relapse
Time Frame
1 year after inclusion
Secondary Outcome Measure Information:
Title
Structural progression
Description
Number of patient with a structural progression of the illness
Time Frame
1 year after inclusion
Title
RA (Rheumatoid Arthritis) remission duration
Description
Evaluation of the remission duration (patient in both clinical and ultrasound remission)
Time Frame
At each follow-up (3,6,9 and 12 months after inclusion)
Title
RA ultrasound remission duration
Description
Evaluation of the ultrasound remission duration
Time Frame
At each follow-up (3,6,9 and 12 months after inclusion)
Title
RA clinical remission duration
Description
Evaluation of the clinical remission duration
Time Frame
At each follow-up (3,6,9 and 12 months after inclusion)
Title
Clinical relapse at one year
Description
Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data
Time Frame
1 year after inclusion
Title
Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)
Description
identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission
Time Frame
At baseline
Title
Radiographic progression at 1 year
Description
Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis
Time Frame
1 year after inclusion
Title
Intra-observator reproductibility
Description
Evaluating the intra-observer reliability for US synovitis through study completion
Time Frame
1 year after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria Patient treated by DMARDs (disease-modifying antirheumatic drug) Patient in confirmed remission for less than 6 months Exclusion Criteria: Patient participating simultaneously in another clinical study with blind treatment Patient participating simultaneously in another clinical study involving decreasing of drug dose Patient in post clinical study exclusion period patients subject to legal protection measures Patient unable to read French Pregnant or breast-feeding women patient treated with Rituximab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaël Mouterde, MD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission

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