Sponsor study identifier
interventional
200
1 country
1
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage. It comprehensively assesses the clinical outcomes of the patients and aims to compare the clinical efficacy and safety of icoxib as a combined add-on treatment versus simple hormone shock therapy during the acute phase of NMOSD.Using simple hormone shock therapy (IVMP) as the control group, the efficacy and safety of etanercept treatment in the acute attack phase of Chinese patients with AQP4-positive neuromyelitis optica spectrum disorder (NMOSD) were evaluated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2026
Actual (reported)February 6, 2026
Actual (reported)February 13, 2026
Actual (reported)June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Expanded Disability Status Scale score,EQ-5D-5L,
Evaluate the EDSS score, EQ-5D-5L,
baseline (before the acute attack and before the initiation of this treatment), and after hormone treatment at weeks 1, 2, 3, 4, 8 and 12
Expanded Disability Status Scale
The EDSS score is evaluated by neurologists through a systematic examination. It is based on the assessment of the central nervous system functions (FS). Lower scores focus on evaluating functional impairments, such as numbness in the face or fingers, and visual disorders. Higher scores focus on evaluating functional impairments of the motor system, mainly difficulty in walking. The symptoms are scored from normal (0 points) to severe disability (5-6 points) across 8 systems (pyramidal tract function, cerebellar function, brainstem system function, sensory system function, bladder and rectal function, visual function, mental system function, and mobility function). The EDSS score mainly assesses the patient's neurological functional impairments and the severity of the disease. The score range is 0 to 10 points. The higher the score, the more severe the neurological functional impairment. A score of 0 indicates a normal healthy state, and a score of 10 indicates the death of MS.
Baseline (before the acute attack treatment), after 1st, 2nd, 3rd, 4th week of hormone treatment, 8th and 12th week
Eculizumab add-on treatment group: 1) The timing of eculizumab addition treatment should be within the 1000mg hormone treatment window; 2) Intravenous infusion of 900mg once a week for a total of 4 weeks; 3) The hormone administration regimen is the same as that of the hormone monotherapy group. All patients receiving eculizumab treatment are required to use prophylactic antibiotics and/or vaccination.
Gamma globulin treatment group: 1) The administration of gamma globulin should occur within the 1000mg hormone treatment window; 2) The infusion dose is 0.4g/kg·d \* 5; 3) The hormone administration regimen is the same as that of the single hormone treatment group.
(PETA-NMOSD Study): After the completion of intravenous methylprednisolone (IVMP), according to domestic treatment guidelines, it is necessary to continue immunosuppressive therapy and maintain it to prevent and reduce relapses. The specific treatment regimen is divided into four groups based on the patient's treatment preference.Eculizumab continuation treatment group,B-cell depletion treatment group,Mycophenolate mofetil group,Satellitezhuibao Treatment Group。
the First Medical Center of Chinese PLA General Hospital
Beijing, China
First Submitted
February 6, 2026
First Posted
February 13, 2026
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 30, 2027
EstimatedDiagnosis of ON With or Without MS or NMOSD
Single hormone shock therapy group: 1) Initiate hormone shock therapy during the acute phase of the attack (≤ 21 days); 2) Intravenous injection of methylprednisolone (IVMP) for 14 days: 1000 mg/day (5 days), 500 mg (3 days), 240 mg (3 days), 120 mg (3 days), then switch to oral administration.
Patients who met the inclusion and exclusion criteria were divided into three groups for their acute-phase treatment based on their treatment preferences: 1. Eculizumab plus treatment group: Eculizumab + IVMP (intravenous methylprednisolone pulse therapy) 2. Human immunoglobulin addition treatment group: IVIG + IVMP 3. Single IVMP treatment group: IVMP After completing the acute-phase treatment, patients who met the inclusion and exclusion criteria entered the conversion treatment study (PETA-NMOSD) according to their treatment preferences, and were also divided into three groups: 1. B-cell depletion treatment group: Rituximab/Inalezumab + oral hormone sequential tapering 2. Methylprednisolone group: MMF + oral hormone sequential reduction and maintenance at a low dose 3. Eculizumab continuation treatment group: Eculizumab + oral hormone sequential tapering
Single hormone shock therapy group: 1) Initiate hormone shock therapy during the acute phase of the attack (≤ 21 days); 2) Intravenous injection of methylprednisolone (IVMP) for 14 days: 1000 mg/day (5 days), 500 mg (3 days), 240 mg (3 days), 120 mg (3 days), then switch to oral administration.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 12, 2026
Record last verified: 2026-03
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