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COMPLETED
NCT04876534
PHASE2

Tocilizumab in Active Moderate-severe Graves' Orbitopathy

Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

View on ClinicalTrials.gov

Summary

To treat patientis with active moderate-severe GO with the anti-IL6 receptor monoclonal antibody tocilizubam with the purpose of assesing the efficacy of therapy on active GO and on the proportion of patiens with inactivation and reactivation of disease (Primary Objective) Effect of therapy on disease progression, improvement of QoL, the degree of residual disease after the inflammatory phase and safety of treatment (Secondary Objective)

Official title: Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab (TCZ) or Methylprednisolone (MP) Treatment in Patients With Active Moderate-severe Graves' Orbitopathy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2019-12-18

Completion Date

2026-03-18

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Tocilizumab 20 Mg/mL Intravenous Solution

Intravenous administration

DRUG

MethylPREDNISolone Injectable Solution

Intravenous administration

Locations (4)

Istituto Auxologico Italiano

Milan, MI, Italy

Azienda Ospedaliero, Universitaria Pisana

Pisa, PI, Italy

Azienda Ospedaliera "Sant'Andrea"

Roma, RM, Italy

Mauriziano Umberto I Hospital

Torino, TO, Italy