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

Sponsor
Hospital Clinico Universitario de Santiago
Study ID
NCT01297699
Phase
PHASE3
Status
Completed

Conditions

  • Graves´ Ophthalmopathy
  • Thyroid Associated Ophthalmopathies
  • Thyroid Eye Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab (RoActemra®) — DRUG
    Single intravenous infusion of tocilizumab (8 mg/kg); every 4 weeks during 16 weeks.
  • Sterile 0.9% Sodium Chloride — DRUG
    Single intravenous dip infusion of a sterile 0.9% sodium chloride, every four weeks during 16 weeks.

Study Details

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.

Key Dates

Start date
Mar 31, 2012
Status verified
Jan 2016
Primary completion
Oct 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
  • Placebo Comparator: Sterile 0.9% Sodium Chloride

Primary Outcome Measure

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). ]

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