Etanercept Therapy for Sjogren's Syndrome

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sjogren's Syndrome	Drug: Etanercept	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	28 participants
Primary Purpose:	Treatment
Official Title:	Etanercept Therapy for Sjogren's Syndrome
Study Start Date :	December 1999
Study Completion Date :	November 2003

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

More Information

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Publications:

Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25.

Fox RI, Kang HI. Pathogenesis of Sjögren's syndrome. Rheum Dis Clin North Am. 1992 Aug;18(3):517-38. Review.

Atkinson JC, Fox PC. Sjogren's syndrome: oral and dental considerations. J Am Dent Assoc. 1993 Mar;124(3):74-6, 78-82, 84-6. Review.

ClinicalTrials.gov Identifier:	NCT00001954 History of Changes
Other Study ID Numbers:	000026; 00-D-0026
First Posted:	January 19, 2000
Last Update Posted:	March 4, 2008
Last Verified:	November 2003

Keywords provided by National Institutes of Health Clinical Center (CC):

Clinical Trial; Autoimmune; Disease Activity; Cytokine	Saliva; Xerostomia; Salivary Glands; Sjogren's Syndrome

Additional relevant MeSH terms:

Syndrome; Sjogren's Syndrome; Dry Eye Syndromes; Disease; Pathologic Processes; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases	Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents