Clinical Trial: Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Hospital Clinico Universitario de Santiago

Current Primary Outcome: 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). ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Clinical response of patients 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, by the quality of life questionnaires: SF-36 and GO-QoL [ 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 the observation 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 by patients or diagnosed by the doctor. [ Time Frame: 12 months ]


Information By: Hospital Clinico Universitario de Santiago

Dates:
Date Received: February 16, 2011
Date Started: March 2012
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016