Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Location status: Recruiting
Location contact
Xixi Yang, MD, PhD
CONTACT
Xixi Yang, MD, PhD
SUB_INVESTIGATOR
Zheng Liu, MD, PhD
CONTACT
NCT Number: NCT07762872
This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and exploratory endpoints (e.g., blood inflammatory markers and visual function), with the aim of evaluating the efficacy and safety of Satralizumab in the early treatment of NMOSD-thereby providing patients with more effective therapeutic options and further optimizing the clinical management of NMOSD.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Beijing, Beijing Municipality, 100053, China
Location status: Recruiting
Xixi Yang, MD, PhD
CONTACT
Xixi Yang, MD, PhD
SUB_INVESTIGATOR
Zheng Liu, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
As recommended in the prescribing information, patients will receive subcutaneous satralizumab Injection as part of their routine treatment. The loading dose is 120 mg administered at Weeks 0, 2, and 4, followed by a maintenance dose of 120 mg every 4 weeks. Maintenance treatment is recommended for a minimum duration of 24 weeks.
Time frame: 24 weeks
Change in EDSS score between at baseline and at 6 months of treatment
Time frame: 12 weeks
Change in EDSS score between at baseline and at 3 months of treatment
Time frame: 12 weeks
Changes in mRS between at baseline and at 3 months of treatment
Time frame: 12 weeks
Changes in EQ-5D between at baseline and at 3 months of treatment
Time frame: 12 weeks
Changes in ADL score between at baseline and at 3 months of treatment
Time frame: 24 weeks
Changes in mRS between at baseline and at 6 months of treatment
Time frame: 24 weeks
Changes in EQ-5D between at baseline and at 6 months of treatment
Time frame: 24 weeks
Changes in ADL score between at baseline and at 6 months of treatment
Time frame: 24 weeks
Relapse events occurring within 6 months of treatment
Contact information is provided by the study sponsor or research team.
Xixi Yang, MD, PhD
CONTACT
Zheng Liu, MD, PhD
CONTACT
Junwei Hao, MD
Other
Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study
Acronym: SATURN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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