Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001954
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Etanercept Therapy for Sjogrens Syndrome
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Etanercept Therapy for Sjogrens Syndrome
Status:
COMPLETED
Status Verified Date:
2003-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the effectiveness of etanercept Enbrel for treating Sjogrens syndrome-an autoimmune disease that affects the secreting glands In autoimmune diseases the immune system attacks the bodys 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 Sjogrens syndrome can also cause dryness of the skin and of mucous membranes in the nose throat airways and vagina
Patients with Sjogrens syndrome who have had oral and eye examinations under NIDCRs 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 Sjogrens syndrome are autoimmune disorders of the connective tissue Laboratory studies also indicate that etanercept may be an effective treatment for Sjogrens syndrome
Patients with Sjogrens syndrome who have had oral and eye examinations under NIDCRs 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 Sjogrens syndrome are autoimmune disorders of the connective tissue Laboratory studies also indicate that etanercept may be an effective treatment for Sjogrens syndrome
Detailed Description:
Sjogrens 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 timesweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0026 | None | None | None |