Role of Ultrasound for Evaluating Rheumatoid Arthritis in... | NCT02618954

Studies
Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission

NCT02618954

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jun 11, 2018Actual

Enrollment

116Actual

Phase

Not Applicable

Conditions

Rheumatoid Arthritis in Remission

Interventions

Articular ultrasound

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Nov 19, 2015

First Submission Date that Met QC Criteria

Nov 27, 2015

First Posted Date

Dec 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2018

Last Update Posted Date

Jun 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study patient	Other	Articular ultrasound at each study follow-up	Other: Articular ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Articular ultrasound	Other	(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint	Study patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1 year pejorative evolution	Number of patient with a clinical relapse	1 year after inclusion

Secondary Outcomes

Measure	Description	Time Frame
Structural progression	Number of patient with a structural progression of the illness	1 year after inclusion
RA (Rheumatoid Arthritis) remission duration	Evaluation of the remission duration (patient in both clinical and ultrasound remission)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gaël Mouterde, MD	Montpellier University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montpellier University Hospital		Montpellier	Herault	34295	France

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D013585	Synovitis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

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Browse Branches

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