The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD.
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a rare autoimmune disease of the central nervous system, which can cause optic neuritis, myelitis, brainstem encephalitis, or encephalitis. The specific autoantibody against myelin oligodendrocyte glycoprotein antibody (MOG-IgG) has been indicated to contribute to the pathogenesis of the disease. Data from several cohorts suggests that around 50% of adult patients with MOG-IgG may relapse within the first two years of the disease, with most of relapses occurring early after disease onset. Few randomized controlled trials have ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event. There is no drug approved for MOGAD by FDA. IL-6 is a pro-inflammatory cytokine which can promotes B cell activation, blood-brain barrier dysfunction, leukocyte migration, and the production of autoantibodies. Tocilizumab (ACTEMRA®), a humanized monoclonal antibody against the IL-6 receptor, has shown beneficial clinical effects and reduction of the risk of relapses in some patients with MOGAD. However, the efficacy of tocilizumab in MOGAD warrants further clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone.
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
Anhui Provincial Hospital
Hefei, Anhui, China
Time from randomization to the first MOGAD relapse as determined by an adjudication committee
An adjudicated relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.
Time frame: Baseline, Up To 60 Weeks (End of Study)
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study
Disease-related disability was measured by the EDSS. The EDSS was an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement
Time frame: Baseline, Up To 60 Weeks (End of Study)
Dosage of oral steroid at the end of the TOMATO trial
Dosage of oral steroid at the end of the TOMATO trial
Time frame: Baseline, Up To 60 Weeks (End of Study)
Sera MOG-IgG Concentration Over Time
Sera MOG-IgG Concentration was measured by Cell-Based Assay (CBA)
Time frame: Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship
Time frame: Baseline, Up To 60 Weeks (End of Study)
Number of Participants With Adverse Events Serious Adverse Events (SAEs)
A SAE was any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization
Time frame: Baseline, Up To 60 Weeks (End of Study)
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The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Hebei Children's Hospital
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, China
Ordos Central Hospital
Ordos, Inner Mongolia, China
The Third Affiliated Hospital of Soochow University
Changzhou, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
...and 12 more locations
Number of the lesion of the MRI T2WI
Number of the lesion of the MRI T2WI
Time frame: Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)