Etanercept Therapy for Sjogren's Syndrome

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Jan 18, 2000

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility 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.