A prospective observational study on the long-term effectiveness and safety of inebilizumab for IgG4-related diseases in the real world setting in Japan (4SigHT study)

未提供0 个研究点目标入组 100 人开始时间: 待定

适应症

试验速览

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•Patients are eligible for inclusion if they meet all of the following criteria:
•> Patients who have received sufficient explanation regarding participation in this study and have provided written informed consent.
•> Patients diagnosed with IgG4 RD as 'definite' or 'probable' according to the comprehensive diagnostic criteria or organ-specific diagnostic criteria in effect at the time of consent.
•> Patients who, at the time of consent, are scheduled to initiate treatment with inebilizumab (Uplizna IV infusion 100 mg) at a medical institution in Japan.
•> Patients aged 18 years or older at the time of consent.
•> Patients who have available medical records during at least the 52 weeks prior to initiation of inebilizumab, or, if disease onset occurred within 52 weeks prior to enrollment, patients who possess some form of medical record from the time of onset onward.

•Patients are excluded if they meet any of the following criteria:
•> Patients who lack the capacity to provide informed consent.
•> Patients who fall under the contraindications for inebilizumab.
•> Patients who have received B-cell-depleting therapy within the 6 months prior to the enrollment date, or who have received molecular targeted agents other than inebilizumab (excluding administration of inebilizumab in patients who have completed the OLP of the MITIGATE trial).
•> Patients whom the investigator determines to be otherwise unsuitable for participation in this study.

发起方

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