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
|
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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 |
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 |


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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001954
United States, Maryland | |
National Institute of Dental And Craniofacial Research (NIDCR) | |
Bethesda, Maryland, United States, 20892 |
Publications:
ClinicalTrials.gov Identifier: | NCT00001954 History of Changes |
Other Study ID Numbers: |
000026 00-D-0026 |
First Posted: | January 19, 2000 Key Record Dates |
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 |