To develop guidelines for therapeutic trials designed to improve the overall course of systemic sclerosis (SSc), that is, to reduce the development of significant organ damage or death.
A committee developed general guidelines for patient inclusion and exclusion criteria, randomization, blinding of patients and physicians, controls, duration of the trial, investigator training, responses, samples size, study dropouts, statistical analyses, data management, and safety monitoring.
Delphi and nominal group techniques were used.
Briefly, patients with diffuse cutaneous SSc of less than 24 months'duration should be included because they are at greatest risk for the development of severe organ damage and death.
Patients should be excluded if they have other connective tissue diseases, SSc-like illnesses related to exposures or ingestions, severe existing internal organ damage, an unacceptable risk of side effects, or concurrent therapies that might independently influence the outcome.
Guidelines have been established for trials of disease-modifying interventions in SSc.
These guidelines will need to be altered as additional information becomes available.
Any given protocol will be individualized based on the nature of the intervention and objectives of the study.
Nonetheless, each study team should develop a protocol that meets the spirit of these guidelines.
Mots-clés Pascal : Sclérodermie, Homme, Traitement, Chimiothérapie, Essai clinique, Méthodologie, Recommandation, Médicament, Peau pathologie, Tissu conjonctif pathologie, Maladie système, Maladie autoimmune, Immunopathologie
Mots-clés Pascal anglais : Scleroderma, Human, Treatment, Chemotherapy, Clinical trial, Methodology, Recommendation, Drug, Skin disease, Connective tissue disease, Systemic disease, Autoimmune disease, Immunopathology
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0287756
Code Inist : 002B02A06. Création : 01/03/1996.