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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Single intravenous infusion of tocilizumab (8 mg/kg); every 4 weeks during 16 weeks.
Single intravenous dip infusion of a sterile 0.9% sodium chloride, every four weeks during 16 weeks.
Hospital Clínico de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Centro Oftalmológico Moreiras
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Drug efficacy will be established as a decrease in CAS (clinical activity score) by 2 or more points in a scale of 10.
Time frame: It will be measured before treatment (week -4 / 0), after treatment (week 16) and after the end of the follow-up (week 40).
Clinical response of patients who respond to treatment with tocilizumab
Time frame: It will be analyzed before treatment (week -4 / 0), after treatment (week 16) and once to follow up (week 40).
Evaluate the patients quality of life associated with tocilizumab treatment, using SF-36
Time frame: It will be analyzed before treatment (week -4 / 0), after treatment (week 16) and once to follow up (week 40).
Determine time to recurrence during follow-up period
Time frame: It is measured on a weeks-time scale assessed by the physician during patient follow-up visits.
Safety as adverse events reported
Time frame: 12 months
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