Etanercept Therapy for Sjogren's Syndrome
Etanercept
Arthritis+14
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
Treatment Study
Summary
Study start date: December 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps