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Etanercept Therapy for Sjogren's Syndrome

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ClinicalTrials.gov Identifier: NCT00001954
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

January 18, 2000
January 19, 2000
March 4, 2008
December 1999
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Complete list of historical versions of study NCT00001954 on ClinicalTrials.gov Archive Site
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Etanercept Therapy for Sjogren's Syndrome
Etanercept Therapy for Sjogren's Syndrome

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.

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.
Interventional
Phase 2
Primary Purpose: Treatment
Sjogren's Syndrome
Drug: Etanercept
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
Same as current
November 2003
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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.

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001954
000026
00-D-0026
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National Institute of Dental and Craniofacial Research (NIDCR)
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National Institutes of Health Clinical Center (CC)
November 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP