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Autumn daffodils are a first-line treatment for familial Mediterranean fever (FMF), but secondary amyloid degeneration due to persistent inflammation is a concern for patients with FMF who are resistant to alkaloids or alkaloids.
Despite reports that Toshili pearl monoantigen (TCZ) is a recombinant, humanized monoclonal antibody resistant to human lecirtin 6, which can prevent FMF seizures, the long-term safety and effectiveness of TCZ in patients with FMF who are resistant to akiletoids or acetone has not been evaluated.
in the multi-center, open-label trial, initiated by the researchers, TCZ will evaluate the long-term safety of TCZ in patients who participated in placebo-controlled, randomized, double-blind, parallel group trials of achosin-resistant or achosin-resistant FMF.
the study will be conducted at nine centers in Japan.
24 weeks of assessment and examination in the previous study, the trial will begin quickly.
the trial will be completed when the drug is approved for FMF treatment in Japan.
The main endpoints are the occurrence of adverse events, the secondary endpoints include the number of FMF episodes, the number of symptoms associated with the onset, serum C reaction protein and amyloid A levels, the general evaluation of doctors (100mm visual simulation scale (VAS), the general evaluation of patients (100mmVAS) and body temperature.
, the study is expected to obtain evidence of the long-term safety of TCZ as a potential new treatment for patients with FMF who are resistant to alkaloids or alkaloids.
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