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NCT Number: NCT02618954

Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission

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.

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Key information

Conditions

Rheumatoid Arthritis in Remission Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Synovitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital

Montpellier, Herault, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Articular ultrasound

Other

(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint

Primary outcomes

  1. 1 year pejorative evolution

    Time frame: 1 year after inclusion

    Number of patient with a clinical relapse

Secondary outcomes

  1. Structural progression

    Time frame: 1 year after inclusion

    Number of patient with a structural progression of the illness

  2. RA (Rheumatoid Arthritis) remission duration

    Time frame: At each follow-up (3,6,9 and 12 months after inclusion)

    Evaluation of the remission duration (patient in both clinical and ultrasound remission)

  3. RA ultrasound remission duration

    Time frame: At each follow-up (3,6,9 and 12 months after inclusion)

    Evaluation of the ultrasound remission duration

  4. RA clinical remission duration

    Time frame: At each follow-up (3,6,9 and 12 months after inclusion)

    Evaluation of the clinical remission duration

  5. Clinical relapse at one year

    Time frame: 1 year after inclusion

    Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data

  6. Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)

    Time frame: At baseline

    identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission

  7. Radiographic progression at 1 year

    Time frame: 1 year after inclusion

    Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis

  8. Intra-observator reproductibility

    Time frame: 1 year after inclusion

    Evaluating the intra-observer reliability for US synovitis through study completion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study

Acronym: SONORE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2015
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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