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

University Hospital Center (CHU)

Status: Completed

Conditions: Rheumatoid Arthritis in Remission

Treatments: Other: Articular ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02618954

9186

Details and patient eligibility

About

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.

Full 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

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Study patient

Other group

Description:

Articular ultrasound at each study follow-up

Treatment:

Other: Articular ultrasound