Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission

NCT ID: NCT02618954

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-07-31

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

Conditions

Rheumatoid Arthritis in Remission

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study patient

Articular ultrasound at each study follow-up

Group Type: OTHER

Articular ultrasound

Intervention Type: OTHER

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

Interventions

Articular ultrasound

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaël Mouterde, MD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Montpellier University Hospital

Montpellier, Herault, France

Countries

France

Other Identifiers

9186

Identifier Type: -

Identifier Source: org_study_id