Clinical trial NCT02618954: Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission
Official title: Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis in Remission
Keywords: Rheumatoid arthritis
Articular ultrasound
Synovitis
Relapse risk
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: 1 year pejorative evolution
timeFrame: 1 year after inclusion
Secondary outcomes:
measure: Structural progression
timeFrame: 1 year after inclusion
measure: RA (Rheumatoid Arthritis) remission duration
timeFrame: At each follow-up (3,6,9 and 12 months after inclusion)
measure: RA ultrasound remission duration
timeFrame: At each follow-up (3,6,9 and 12 months after inclusion)
measure: RA clinical remission duration
timeFrame: At each follow-up (3,6,9 and 12 months after inclusion)
measure: Clinical relapse at one year
timeFrame: 1 year after inclusion
measure: Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)
timeFrame: At baseline
measure: Radiographic progression at 1 year
timeFrame: 1 year after inclusion
measure: Intra-observator reproductibility
timeFrame: 1 year after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
state: Herault
Study officials:
affiliation: Montpellier University Hospital
name: Gaël Mouterde, MD
role: PRINCIPAL_INVESTIGATOR
References: