Tocilizumab in Active Moderate-severe Graves' Orbitopathy

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ID
NCT04876534
Phase
PHASE2
Status
Unknown

Conditions

  • Graves Ophthalmopathy

Eligibility Criteria

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

Interventions

Study Details

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)

Key Dates

Start date
Dec 18, 2019
Status verified
Aug 2022
Primary completion
Dec 18, 2022
Completion
Dec 18, 2023

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    32 patients with active moderate-severe GO treated with i.v. tocilizumab; Tocilizumab weight adjusted, 8 mg/kg, 1 intravenous infusion every four weeks (+/- 72 hours) for 12 weeks
  • Active Comparator: Methylprednisolone
    32 patients with active moderate-severe GO treated with i.v. methylprednisolone; Methylprednisolone, 500 mg infusion weekly (+/- 48 hours) for 6 weeks, followed by 250 mg infusion weekly (+/- 48 hours) for another 6 weeks

Primary Outcome Measure

Desease inactivation [ Time Frame: at 12 and 24 weeks ]

Central Contacts

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