1. EULAR-ACR joint research projects
  2. Development of Gout Response Criterion

This international group with background in OMERACT studies has accepted the challenge of addressing response criteria for gout that will be applicable to therapeutic trials and clinical practice. Although some criteria such as tophus resolution, disability, and radiographic improvement might apply to some patients the feature that will be applicable to virtually all gout patients will be the ability to abolish or reduce the numbers offlares of acute gouty arthritis.

 

Our proposal begins with a Delphi exercise among worldwide rheumatologists to begin to develop a usable definition of a flare. Reviews of past therapeutic trials have found wide variation in definitions including patient report of a flare, use of a medication that might be appropriate for a flare or health system contact for a flare. Nothing has been validated. The Delphi exercise will evaluate features that might confirm either a patient reported or physician witnessed flare as well as flare severity. Based on initial work by Taylor et al features may include, but are not limited to, joint swelling, redness, pain patterns and decreased function.

 

Following development of proposed flare criteria a structured Face to Face Nominal Group Meeting of a different set of experts will be convened. This group will select criteria to then be evaluated with 5-10 clinical practices in different countries and later in planned prospective clinical therapy trials for which we have agreements for participation.

 

The multicenter clinical validation will examine consecutively seen clinic and emergency patients with proven gout to apply flare criteria for comparison with a “gold standard” of expert rheumatologist impression. The study will focus on longitudinal collection during sequential visits.

 

The prospective therapeutic trials will be for long term urate lowering agents and treatment of acute gout.Assessment will be of validity, reliability and responsiveness to change. Data and analyses will be organized and monitored by our statistician.

 

Our results will be submitted to ACR and EULAR with the objective of achieving agreement on a valid publishable response criterion. The project with the long term validation in clinical trials will be completed by 2009.

  1. Principal participating centers

Jasvinder Singh, MD, MPH

Minneapolis VA Medical Center

Kenneth Saag, MD, MPH and

Richard M. Shewchuk, MD

University of Alabama

Fernando Perez-Ruiz, MD

Hospital de Cruces, Baracaldo, Spain

Maarten Boers, MD

VU Medical Center, Amsterdam, Netherlands

William Taylor, MD

University of Wellington, New Zealand

Lan Chen, MD, PhD

University of Pennsylvania

Vibeke Strand, MD

Stanford University School of Medicine

Thomas Bardin, MD

Hospital Lariboisière, Paris, France

Eswar Krishnan, MD

University of Pittsburgh

Michael Doherty, MD and

Weiya Zhang, MD

Nottingham University, United Kingdom


RELATED INFORMATION

 

Contact

H. Ralph Schumacher, Jr., MD

Professor of Medicine

University of Pennsylvania

Philadelphia VAMC

VA Medical Center

Rheumatology Research, 151K

University and Woodland Aves.

Philadelphia, PA19104

 

Phone: 215-823-4244

Fax: 215-823-6032

schumacr@mail.med.upenn.edu