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DC-ART: decreased inflammatory synovitis

D E Furst¹, P Brooks, A N Malaviya

¹Virginia Mason Research Center, Seattle, WA 9811.

The Journal of Rheumatology. Supplement

|September 1, 1994

Summary

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Defining decreased inflammatory synovitis is crucial for drug development. A proposed definition requires minimum disease activity and improvement in 5 of 6 key clinical measures for patients in studies.

Area of Science:

Rheumatology
Clinical Trial Design
Drug Development

Background:

Accurate definitions of disease states are essential for reproducible clinical trials.
The definition of "decreased inflammatory synovitis" is needed for drug development using SMARD/DC-ART criteria.

Purpose of the Study:

To review literature on indirect, clinical measures of decreased inflammatory synovitis.
To propose a preliminary, testable definition for decreased inflammatory synovitis based on patient response.

Main Methods:

Literature review of indirect and clinical measures for synovitis.
Development of a definition incorporating minimum disease activity and improvement in specific clinical criteria.

Main Results:

Related Experiment Videos

A preliminary definition for decreased inflammatory synovitis was developed.
The definition includes criteria such as joint swelling, joint tenderness, erythrocyte sedimentation rate, physician global assessment, and pain.

Conclusions:

The proposed definition requires minimum disease activity and improvement in at least 5 of 6 specified criteria.
Prospective validation in clinical trials is necessary to refine the definition and establish an appropriate pooled index.