Tokyo, March 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060821) titled 'A medical chart review evaluating pregnancy outcomes and infant safety in pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) who were exposed to satralizumab' on March 6.
Study Type:
Observational
Primary Sponsor:
Institute - Chugai Pharmaceutical Co., Ltd.
Condition:
Condition - Neuromyelitis optica spectrum disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the impact of satralizumab on pregnancy outcomes in patients with neuromyelitis optica spectrum disorder (NMOSD)
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1.Patients who have been fully informed about the study and have provided voluntary written informed consent
2.Patients diagnosed with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD)
3.Patients who received satralizumab within 6 months prior to the last menstrual period (LMP) or during pregnancy
4.Patients for whom the pregnancy outcome is known as of March 31, 2026. In cases of live birth, the infant is older than 1 year as of June 30, 2026; however, cases in which the infant died before reaching 1 year of age are eligible
Key exclusion criteria - No exclusion criteria will be established in this study.
Target Size - 10
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 12 Month 18 Day
Date of IRB - 2025 Year 12 Month 18 Day
Anticipated trial start date - 2026 Year 03 Month 10 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069513
Disclaimer: Curated by HT Syndication.
