TOMATO
What it found
No result yet.
What was tested
Treatment tested
- Tocilizumab
Interleukin-6 receptor alpha subunit inhibitor
- Prednisone
Glucocorticoid receptor agonist
What it measured
Main measures
Time from randomization to the first MOGAD relapse as determined by an adjudication committee
Baseline, Up To 60 Weeks (End of Study)
Relapses
Other measures (6)
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study
Baseline, Up To 60 Weeks (End of Study)
Disability progressionDosage of oral steroid at the end of the TOMATO trial
Baseline, Up To 60 Weeks (End of Study)
Sera MOG-IgG Concentration Over Time
Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)
Number of Participants With Adverse Events (AEs)
Baseline, Up To 60 Weeks (End of Study)
SafetyNumber of Participants With Adverse Events Serious Adverse Events (SAEs)
Baseline, Up To 60 Weeks (End of Study)
SafetyNumber of the lesion of the MRI T2WI
Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)
MRI lesions
Who could take part
MOGAD · 12 and over
Inclusion Criteria: 1. Participants who are aged ≥12 years at the time of signing Informed Consent Form 2. Confirmed diagnosis of MOGAD with a history of ≥1 MOGAD relapse in the 12 months prior to screening or ≥2 attacks in the 24 months prior to screening 3. Anti-MOG antibody seropositive 4. For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of tocilizumab 5. Patients must give written informed consent Exclusion Criteria: 1. Any concomitant disease other than MOGAD that may require treatment with oral immunosuppressants or prednisone at doses >20 mg/day (or equivalent) 2. Receipt of the following at any time prior to randomization Alemtuzumab Total lymphoid irradiation Bone marrow transplant T-cell vaccination therapy Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal. Receipt of intravenous immunoglobulin (IVIG) or plasma exchange (PE) within 1 month prior to randomization. Receipt of any of the following within 3 months prior to randomization: Natalizumab (Tysabri®). Methotrexate Mitoxantrone Cyclophosphamide Eculizumab Receipt of any of the following within 6 weeks prior to randomization: Tacrolimus Cyclosporin Mycophenolate mofetil 3. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of tocilizumab 4. Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline 5. Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) 6. Participants with positive screening tests for hepatitis B and C 7. Receipt of live or live attenuated vaccine within 6 weeks prior to baseline 8. Known history of a severe allergy or reaction to any biologic therapy. 9. History of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to randomization 10. WBC \< 3.0 × 10\^3/mL, ANC \< 2.0 × 10\^3/mL, PLT \< 10 × 10\^4/mL, AST or ALT>1.5 ×ULN, Lymphocyte count \< 0.5 × 10\^3/mL
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD.
Papers
Loading reviews and guidelines…
Related trials
- Meteoroid
Phase 3 · Running, not recruiting
Still running
History
Started
Jul 2024
Main results due
Jan 2026
Finished
Jul 2026
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