Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03195296
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2017-06-19
Brief Title:
T and B Cells in Graves Orbitopathy
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
T and B Cells Infiltrating Orbital Tissues in Graves Orbitopathy GO and Their Relation With GO Features
Status:
COMPLETED
Status Verified Date:
2018-02
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:
LYMPHGO
Brief Summary:
Graves orbitopathy GO is an inflammatory eye disease associated in 95 of patients with Graves hyperthyroidism GH in 3-4 with hypothyroid autoimmune thyroiditis and in 1-2 with thyroid autoimmunity in the absence of thyroid dysfunction the former known as euthyroid GO The pathogenesis of GO is autoimmune with the TSH-receptor being considered the major autoantigen thereby establishing a pathogenetic link between the thyroid and orbital tissue Thus TSH-receptor is expressed by orbital fibroblasts where it forms a complex with the IGF-1 receptor Unlike GH which is notoriously caused by TSH-receptor stimulating autoantibodies GO is believed to reflect cell-mediated autoimmunity as suggested by studies showing a Th1-like pattern of cytokine release by primary cultures of orbital infiltrating lymphocytes from GO patients On the other hand a role of B lymphocytes has emerged in recent years based on the observation that the anti-CD20 monoclonal antibody rituximab has a beneficial effect on GO activity as demonstrated by a recent randomized clinical trial in which rituximab was compared with intravenous glucocorticoids GC being the former the standard treatment of moderately-severe GO The explanation for the findings was that B lymphocytes are involved in the pathogenesis of GO as antigen-presenting cells However in spite of the above mentioned promising observations another randomized clinical trial in which rituximab was compared with placebo provided opposite results Thus rituximab had no effect at all on GO Data from the two studies were confronted and major differences between the two cohorts emerged especially concerning GO activity leading to the conclusion that rituximab may be effective for active but not for inactive GO Rituximab has been employed also for autoimmune diseases other than GO including type 1 diabetes In the former it was shown that the effectiveness of rituximab paralleled the presence of CD20-positive infiltrating lymphocytes in pancreas islets We therefore postulated that something similar may occur in GO because of which we planned the present perspective observational study aimed at determining the presence and immunohistochemical features of lymphocytes infiltrating orbital tissues in patients with GO and to relate them with the clinical features of GO
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None