Tokyo, Oct. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059519) titled 'Special Drug Use Result Survey of IMAAVY in patients with generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids)' on Oct. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Janssen Pharmaceutical K.K.
Condition:
Condition - generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This survey is to be conducted in patients who receive IMAAVY 1200 mg for I.V. Infusion and IMAAVY 300 mg for I.V. Infusion for the first time (Hereinafter referred to as this drug) for generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids) to evaluate the occurrence status of infection at the time of administration (including serious cases) and to confirm and investigate the relationship between the change in total IgG concentration and the occurrence and seriousness of infection.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who are receiving their first administration of this drug for generalized myasthenia gravis(limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids) .
Key exclusion criteria - Patients with prior use of IMAAVY
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 16 Day
Anticipated trial start date - 2025 Year 11 Month 30 Day
Last follow-up date - 2031 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068079
Disclaimer: Curated by HT Syndication.
