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Clinical Trial Summary

The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy.

Indices for follow-up will include:

- Clinical activity score

- Anti-TSH receptor antibody levels

- Thickening of extraocular muscles per ultrasound

- Quality of life score for Graves Orbitopathy patients


Clinical Trial Description

Graves Orbitopathy (GO) is an autoimmune inflammatory disorder causing visual morbidity, cosmetic morbidity and interference with quality of life. The disease has an inflammatory stage and a non-inflammatory, fibrotic stage.

Treatment of inflammatory stage moderate-severe GO includes steroids, as recommended by the EUGOGO consortium. However, the length of treatment needed and the risk of steroid side-effects may lead to multiple undesired treatment induced morbidity.

Antibiotics of the macrolide group posses known immune-modulatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of macrolide antibiotics for delaying graft rejection following lung transplants.

We propose to test the effect of this class of antibiotics for non-sight threatening, moderate-severe, inflammatory GO. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01379196
Study type Interventional
Source Rabin Medical Center
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date May 2011
Completion date December 2014

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