Rituximab Treatment of Graves' Dysthyroid Ophthalmopathy
Summary
This study is designed to treat patients with Graves' disease with Rituximab in an attempt to prevent or reverse the physically deforming and debilitating consequences of this disease.
Description
Graves' Dysthyroid ophthalmopathy is an autoimmune disease characterized by inflammatory changes of the periocular and orbital region often in association with an underlying thyroid abnormality. These changes can be extremely debilitating and may lead to visual loss. Attempts at limiting or reversing the phenotypic expression of Graves' ophthalmopathy through aggressive orbital decompression surgery or targeting the inflammatory disease, using high dose systemic corticosteroids and/or orbital radiotherapy, have been limited to date by treatment ineffectiveness and co-morbidities. Selective B-cell depletion therapy offers a potential treatment alternative. This study is designed to treat patients with Graves' disease with Rituximab in an attempt to prevent or reverse the physically deforming and debilitating consequences of this disease.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Graves' Dysthyroid Ophthalmopathy
Intervention
Rituximab
Location
Rona Z. Silkiss, MD, FACS
Oakland
California
United States
94609
Status
Recruiting
Source
Silkiss, Rona Z., M.D., FACS
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00424151
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Graves Ophthalmopathy
An autoimmune disorder of the EYE, occurring in patients with Graves disease. Subtypes include congestive (inflammation of the orbital connective tissue), myopathic (swelling and dysfunction of the extraocular muscles), and mixed congestive-myopathic ophthalmopathy.
Graves Disease
A common form of hyperthyroidism with a diffuse hyperplastic GOITER. It is an autoimmune disorder that produces antibodies against the THYROID STIMULATING HORMONE RECEPTOR. These autoantibodies activate the TSH receptor, thereby stimulating the THYROID GLAND and hypersecretion of THYROID HORMONES. These autoantibodies can also affect the eyes (GRAVES OPHTHALMOPATHY) and the skin (Graves dermopathy).
Immunoglobulins, Thyroid-stimulating
Autoantibodies that bind to the thyroid-stimulating hormone (TSH) receptor (RECEPTORS, THYROTROPIN) on thyroid epithelial cells. The autoantibodies mimic TSH causing an unregulated production of thyroid hormones characteristic of GRAVES DISEASE.
Receptors, Thyrotropin
Cell surface proteins that bind pituitary THYROTROPIN (also named thyroid stimulating hormone or TSH) and trigger intracellular changes of the target cells. TSH receptors are present in the nervous system and on target cells in the thyroid gland. Autoantibodies to TSH receptors are implicated in thyroid diseases such as GRAVES DISEASE and Hashimoto disease (THYROIDITIS, AUTOIMMUNE).
Clinical Trials
Trial of Rituximab for Graves' Ophthalmopathy
This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be...
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
The purpose of this study is to determine whether radioactive iodine, as compared to anti-thyroid medications, is a risk factor for the development or progression of thyroid-associated oph...
Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)
AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have...
The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy
The relationship between the method of the treatment of hyperthyroidism due to Graves' disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to compare the r...
A Study of Otelixizumab, a New Treatment for Thyroid Eye Disease
The purpose of this study is to investigate the safety and tolerability of otelixizumab in patients with Graves' ophthalmopathy (thyroid eye disease). There is currently no alternative th...
PubMed Articles
Interleukin-7 expression in tears and orbital tissues of patients with Graves' ophthalmopathy.
The aim of this study was to explore whether IL-7 participates in the pathogenesis of Graves' ophthalmopathy (GO). This was a prospective study. 20 GO patients (40 eyes) and 20 healthy volunteers (40...
Assessing Graves' ophthalmopathy-specific quality of life in Korean patients.
AimTo investigate the clinical significance of Grave's ophthalmopathy-specific quality of life (GO-QOL) in Korean patients.MethodsA cross-sectional study was conducted at the Department of Ophthalmolo...
The association of carotid cavernous fistula with Graves' ophthalmopathy.
Graves' ophthalmopathy (GO) is one of the frequent manifestations of the disorder which is an inflammatory process due to fibroblast infiltration, fibroblast proliferation and accumulation of glycosam...
The role of IL-15 and selenium in Graves ophthalmopathy.
Prevalence and natural history of Graves' orbitopathy in the XXI century.
Graves' orbitopathy (GO) is an autoimmune disorder and the main extrathyroidal expression of Graves' disease. There is a spectrum of ocular involvement in Graves' disease, from complete absence of sym...
