Thyroid Eye Disease Clinical Trial
Official title:
Clinical Trial Phase III, Parallel Group, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab Administration in Patients With Moderate-to-severe or Sight-threatening Graves' Ophthalmopathy (GO), That Had Not Responded Adequately to Treatment With Intravenous Corticoid Pulses.
The purpose is to investigate tocilizumab administration in patients with moderately to
severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with
corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic
alternative.
The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment
in order to provide a better alternative to surgery for this patients.
Thyroid orbitopathy or Graves´orbitopathy (GO) is manifested for inflammation of the orbital
and periorbital soft tissues. Ten percent of patients with GO will have long-term serious
eye problems.
The cause of the GO is complex. Autoreactive T cells recognize an autoantigen, the TSH
receptor present in the orbit and thyroid follicular cell, secrete cytokines (IL-6), which
stimulate the fibroblasts to synthesize glycosaminoglycan, which draws liquid produce
periorbital edema and muscle, causing exophthalmos.
This approach suggests that inhibition of IL-6 can be an effective treatment for this
problem on the basis that tocilizumab specifically binds to the receptors of the IL-6, both
soluble and membrane-bound. Tocilizumab has been shown to inhibit signaling mediated for
IL-6Rm IL-6Rs.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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