NCT00444691

Brief Summary

It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis). An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA). It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments. In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients. Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
2 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

March 7, 2007

Last Update Submit

August 25, 2009

Conditions

Rheumatoid Arthritis

Keywords

synovitis scoresensitivity to changeclinical examinationultra-sonography

Outcome Measures

Primary Outcomes (2)

  • joint score evaluated by clinical examination

    baseline and 1, 2, 3 and 4 months after baseline

  • joint score evaluated by ultra-sonography

    baseline and 1, 2, 3 and 4 months after baseline

Secondary Outcomes (2)

  • DAS28 Synovial index

    baseline and 1, 2, 3 and 4 months after baseline

  • ACR Synovial index (66 sites)

    baseline and 1, 2, 3 and 4 months after baseline

Interventions

ultra-sonographyDEVICE

o The ultrasonographic evaluation was performed on 38 joints: the 28 joints included in DAS28 (e.g. shoulderx2, elbowx2, wristx2, metacarpo-phalangeal (MCP)x10, proximal inter phalangeal (PIP)x10, kneex2) and also the metatarso-phalangeal (MTPx10). Systematic multiplanar gray-scale (mode B) and Power Doppler examination was carried out with commercially available real-time scanners using multi-frequency linear transducers (7-12 MHz). The ultrasonographic evaluation was performed at baseline and 1, 2, 3, and 4 months after baseline.

Also known as: scanners:, ESAOTE Technos MPX, TOSHIBA APLIO, ESAOTE MyLab, PHILIPS HD11, BK Mini Focus.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with rheumatoid arthritis meeting ACR criteria.
  • Justifying anti-TNF alpha treatment (switch or first administration).
  • To have at least 6 synovitis at the clinical examination necessary for the DAS evaluation
  • To accept to participate in this study (informed consent signed).

You may not qualify if:

  • Minor patients.
  • Pregnancy.
  • Breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU-Brugmann

Brussels, 1020, Belgium

Location

Hôpital Ambroise Paré

Boulogne, 92104, France

Location

CHU de la Cavale Blanche

Brest, 29609, France

Location

CHU Côte de Nacre

Caen, 14000, France

Location

CHU A. Michallon

Grenoble, 38000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Cochin

Paris, 75006, France

Location

Hôpital de la Pitié

Paris, 75013, France

Location

CHU de RENNES - Hôpital Sud

Rennes, 35000, France

Location

CHU Nancy-Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chales G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.

    PMID: 27042336DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Tomography Scanners, X-Ray Computed

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Maxime DOUGADOS, Professor

    ARCR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2008

Study Completion

April 1, 2010

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

BE(1)FR(9)