title: Response criteria for clinical trials in systemic lupus erythematosus.
abstract: For clinical trials of mild to moderately active systemic lupus erythematosus, a criteria for a responder is proposed. An a priori definition has a variety of advantages including the ability to compare trials with one another, expand the potential number of eligible subjects; increase sensitivity and reduce sample size requirements; exploit innovative; expedient clinical trial designs; and also quantitate a flare, as well. The availability of quantitative disease activity measures permits the development of a responder index.
authors.affiliation: Department of Medicine, Harvard Medical School, Robert B Brigham Multipurpose Arthritis and Musculoskeletal Diseases Center, Boston, MA, USA.
authors.forename: M H
authors.initials: MH
authors.lastname: Liang
authors.forename: P R
authors.initials: PR
authors.lastname: Fortin
mesh_terms: D001699:Biometry; D002986:Clinical Trials as Topic; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000503:physiopathology / Q000628:therapy*; D008962:Models, Theoretical; D016896:Treatment Outcome