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

NCT01297699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-01-20

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Tocilizumab (RoActemra®)

Single intravenous infusion of tocilizumab (8 mg/kg); every 4 weeks during 16 weeks.

DRUG

Sterile 0.9% Sodium Chloride

Single intravenous dip infusion of a sterile 0.9% sodium chloride, every four weeks during 16 weeks.

Sponsors & Collaborators

  • Fundación Ramón Domínguez

    collaborator OTHER

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • Juan Jesús Gómez-Reino Carnota, MD, PhD · Hospital Clínico de Santiago

  • Jóse V. Pérez Moreiras, MD, PhD · Centro Oftalmológico Moreiras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297699 on ClinicalTrials.gov