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Tocilizumab in Active Moderate-severe Graves' Orbitopathy

NCT04876534 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-08-04

No results posted yet for this study

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)

Conditions

  • Graves Ophthalmopathy

Interventions

DRUG

Tocilizumab 20 Mg/mL Intravenous Solution

Intravenous administration

DRUG

MethylPREDNISolone Injectable Solution

Intravenous administration

Sponsors & Collaborators

  • Mauriziano Umberto I Hospital

    collaborator OTHER

  • Istituto Auxologico Italiano

    collaborator OTHER

  • Azienda Ospedaliera "Sant'Andrea"

    collaborator OTHER

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Mario MS Salvi, MD · Fondazione IRCCS "Cà Granda" Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2022-12-18
Completion
2023-12-18

Countries

  • Italy

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 NCT04876534 on ClinicalTrials.gov