Etanercept Therapy for Sjogren's Syndrome
Etanercept
Arthrite+14
+ Arthrite Rhumatoïde
+ Maladies Auto-immunes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1999
Date à laquelle le premier participant a commencé l'étude.Sjogren's syndrome (SS) is an autoimmune disease chiefly affecting the exocrine glands. Manifestations of SS include salivary and lacrimal gland dysfunction. There is no generally accepted treatment for the underlying autoimmune reactivity or the exocrine gland dysfunction in SS. We propose to test the effects of etanercept therapy. In a randomized, double-masked, outpatient protocol, patients will receive etanercept for 2 times/week for 3 months. Therapy will be given by subcutaneous injection. Efficacy of treatment will be assessed by monitoring salivary and lacrimal function, serological markers of autoimmune activity, and subjective reports of local and systemic symptoms. The present trial will serve as a screening protocol to identify if etanercept should be further analyzed in a larger clinical trial for efficacy.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.28 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
INCLUSION CRITERIA Documented primary or secondary SS. Absence of confounding health problems. No contraindications to etanercept therapy. SS patients cannot have sarcoidosis, HIV infection, or lymphoma. Patients must have one of the following abnormal autoimmune serologies associated with SS (i.e. positive ANA, RF, and anti-SS-A, or anti-SS-B). Patients may use pilocarpine provided that they hold their dose on visit days when saliva is collected. Patients taking DMARD's, such as hydroxychloroquine, must be on a stable dose. Participants may take NSAIDs or acetaminophen. EXCLUSION CRITERIA Patients must not have physical or mental conditions that may make them unable to comply. Subjects may continue their other long-term medications with the exception of tricyclic antidepressants and anti-cholinergics, which may affect salivary gland function. Patients cannot take experimental drugs during the duration of the protocol. Children will be excluded due to additional risks that may occur with etanercept.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, United StatesOuvrir National Institute of Dental And Craniofacial Research (NIDCR) dans Google Maps