Safety and Efficacy of Tocilizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT06452537
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone.
  • Prednisone — DRUG
    Prednisone tapering protocol : If the starting dose is over 20mg/day, then reduce by one tablet weekly. Until the dose is reduced to 20mg/day then 20mg/day for two weeks→17.5mg/day for two weeks→12.5mg for four weeks→10mg for four weeks→7.5mg as a maintain dosage

Study Details

The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD.

Key Dates

Start date
Jul 9, 2024
Status verified
Jan 2026
Primary completion
Jan 1, 2026
Completion
Jul 1, 2026

Study Design

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

Arms

  • Experimental: Tocilizumab with oral prednisone
    Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone
  • Experimental: Prednisone

Primary Outcome Measure

Time from randomization to the first MOGAD relapse as determined by an adjudication committee [ Time Frame: Baseline, Up To 60 Weeks (End of Study) ]

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