Tokyo, Jan. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060279) titled 'A multicenter retrospective observational study of patients with generalized myasthenia gravis treated with efgartigimod' on Jan. 7.
Study Type:
Observational
Primary Sponsor:
Institute - argenx Japan K.K.
Condition:
Condition - generalized myasthenia gravis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To describe the medical history of patients with generalized myasthenia gravis (gMG) treated with efgartigimod, including the treatment history of gMG, symptoms of gMG, and adverse events before and after efgartigimod treatment. This study will use a post-marketing surveillance study data.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1)Patients enrolled in the specific post-marketing surveillance (PMS) study for efgartigimod intravenous (IV) formulation or subcutaneous (SC) formulation for generalized myasthenia gravis (gMG)
2)Patients who had no prior treatment with efgartigimod before enrollment in PMS
Key exclusion criteria - Patients who had prior treatment with efgartigimod before enrollment in PMS
Target Size - 150
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 08 Month 07 Day
Date of IRB - 2025 Year 08 Month 26 Day
Anticipated trial start date - 2026 Year 01 Month 06 Day
Last follow-up date - 2026 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068864
Disclaimer: Curated by HT Syndication.
