Etanercept Therapy for Sjogren's Syndrome

NCT00001954 | Completed Phase 2

• 2 other identifiers: 00002600-D-0026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Keywords

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

Interventions

Etanercept DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.14219/jada.archive.1985.0384.

  PMID: 3858368 BACKGROUND

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

  PMID: 1323135 BACKGROUND

• 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. doi: 10.14219/jada.archive.1993.0064.

  PMID: 8335784 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: December 1, 1999
• Study Completion: November 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-11

Locations

US (1)