Etanercept Therapy for Sjogren's Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2003-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's syndrome-an autoimmune disease that affects the secreting glands. (In autoimmune diseases, the immune system attacks the body's own tissues.) Reduced lacrimal (tear) gland function causes dry eyes with a scratchy sensation, and, in severe cases, vision be may impaired. Reduced salivary gland function causes dry mouth, resulting in greatly increased tooth decay. Dry mouth also makes chewing and swallowing difficult, which may lead to nutrition deficiencies. Sjogren's syndrome can also cause dryness of the skin and of mucous membranes in the nose, throat, airways, and vagina.

Patients with Sjogren's syndrome who have had oral and eye examinations under NIDCR's protocol 84-D-0056 may participate in this study. Participants will be randomly assigned to receive either etanercept or placebo (an inactive look-alike substance) by injection under the skin twice a week for 3 months.

Patients will be seen for evaluation before treatment begins (baseline) and again at 1, 3, and 4 months. The baseline and 3-month visits include a physical examination, eye examination, saliva collection from salivary glands, blood tests, and evaluation for changes in symptoms and treatment side effects. The 1- and 4-month visits include saliva collection, blood tests, and review of symptoms and treatment side effects. In addition, blood will be drawn every 2 weeks for safety monitoring. Patients will also be surveyed weekly (by telephone or during the clinic visit) about symptoms and treatment side effects.

The Food and Drug Administration has approved Enbrel for treating certain forms of arthritis, which, like Sjogren's syndrome, are autoimmune disorders of the connective tissue. Laboratory studies also indicate that etanercept may be an effective treatment for Sjogren's syndrome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

NCT04819269

Dry Eye Disease Sjögren Syndrome

COMPLETED PHASE3

A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

NCT02915159

Sjogrens Disease

COMPLETED PHASE3

TrueTear in Sjogren's Disease Patients

NCT03719885

Dry Eye Syndromes Sjogren's Syndrome

COMPLETED NA

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

NCT05946941

Sjögren's Syndrome

RECRUITING PHASE3

Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome

NCT02203188

Sjogren's Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sjogren's Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etanercept

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No