Neuromyelitis Optica Spectrum Disorder AttackPhase 4ETA/PETA-NMOSDNCT07410039
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
A Phase 4 study testing Eculizumab+IVMP, IVIG+IVMP and IVMP in people with Neuromyelitis Optica Spectrum Disorder Attack, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder Attack
- What is being tested?
- Eculizumab+IVMP, IVIG+IVMP and IVMP
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years old, gender not restricted.
- Patients who meet the diagnostic criteria for NMOSD as set by the International Panel for NMO Diagnosis (IPND) in 2015, and have positive serum AQP4-IgG (by CBA method or live cell method).
- Acute phase of NMOSD-ON, defined as new or worsening optic nerve dysfunction (visual acuity decline accompanied or not by eye pain and visual field defect), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent optic nerve damage on imaging (new or expanded T2WI lesions, with enhancement); the best corrected visual acuity (BCVA) of the affected eye during the acute phase of NMOSD-ON (if both eyes are affected simultaneously, the worse eye is considered) drops from above 0.3 to ≤ 0.1.
- Acute phase of NMOSD-TM, defined as new or worsening spinal cord dysfunction (limb weakness or numbness, accompanied or not by urinary and defecation disorders), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent spinal cord damage on imaging (new or expanded T2WI lesions, with enhancement); the EDSS score during the acute phase of NMOSD-TM increases from ≤ 4.0 to ≥ 6.0.
- Clinical onset and recurrence determination requires unanimous judgment by each center and the center committee (an independent group of 3 people).
- Agree to receive meningococcal vaccine or use eculizumab during and 2 weeks after the medication.
- Sign the informed consent.
Who cannot join
- Damage to the optic nerve or spinal cord caused by other non-NMOSD-related factors.
- Abnormal laboratory indicators that need to be excluded from the subjects include, but are not limited to the following indicators:
- Neutrophils < 1.5 × 109/L, Hemoglobin < 90g/L, Platelet count < 75 × 109/L; Serum creatinine > 1.5 × ULN, Total bilirubin > 1.5 × ULN, Aspartate aminotransferase (AST) > 1.5 × ULN, Alanine aminotransferase (ALT) > 1.5 × ULN, Alkaline phosphatase > 2 × ULN ； HbA1c > 8% (for diabetic patients); GFR < 60 mL/minute/1.73m2.
- Pregnant or lactating women, as well as those planning to become pregnant during the study period.
- Those who have received PE/IA/IVIG/FcRn/B-cell deletion/C5/IL-6 treatment within 1 month before enrollment.
- Active infections: active hepatitis B, hepatitis C, syphilis or HIV infection; active systemic infections or immunodeficiency diseases; unrelieved meningococcal infection of the meninges, or patients with severe infections that cannot use immunosuppressive drugs.
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- Patients with severe internal or external diseases (not limited to such as heart failure, unstable angina pectoris, respiratory failure, pulmonary insufficiency, cachexia, organ transplantation, etc.).
- Those who have had or currently have an untreated malignant tumor that is not well controlled.
- Patients with serious physical or mental diseases that may affect the smooth implementation of the study.
- Patients known to be allergic to monoclonal drugs, murine proteins or any excipients.
- Patients who are intolerant to methylprednisolone or gamma globulin.
- Patients who cannot complete the magnetic resonance enhanced scan screening.
- Patients who are participating in other interventional clinical trials.
- Patients who cannot understand the questionnaire questions or cooperate with the questionnaire survey.
- Situations that the research team collectively deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Medical Center of Chinese PLA General Hospital
Beijing
Dehui huang, +86-13911079787, huangdehui@gmail.com
lei wu, Associate Chief Physician
About this study
Official title: Eculizumab Add-On Therapy in the Acute Phase of Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Real-World Study
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.
Read the detailed description
Patients who met the inclusion and exclusion criteria were divided into three groups for their acute-phase treatment based on their treatment preferences:
- Eculizumab plus treatment group: Eculizumab + IVMP (intravenous methylprednisolone pulse therapy)
- Human immunoglobulin addition treatment group: IVIG + IVMP
- Single IVMP treatment group: IVMP
- Being tested
- Eculizumab+IVMP, IVIG+IVMP, IVMP
- Keywords
- Neuromyelitis Optica Spectrum Disorder (NMOSD), acute attack phase, eculizumab add-on therapy, AQP4-IgG positive
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eculizumab+IVMPDrug
(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。
IVIG+IVMPDrug
Patients who met the inclusion and exclusion criteria were divided into three groups for their acute-phase treatment based on their treatment preferences:
- Eculizumab plus treatment group: Eculizumab + IVMP (intravenous methylprednisolone pulse therapy)
- Human immunoglobulin addition treatment group: IVIG + IVMP
- 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:
- B-cell depletion treatment group: Rituximab/Inalezumab + oral hormone sequential tapering
- Methylprednisolone group: MMF + oral hormone sequential reduction and maintenance at a low dose
- Eculizumab continuation treatment group: Eculizumab + oral hormone sequential tapering
IVMPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab+IVMP | Active comparator | 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. Receives: Drug: Eculizumab+IVMP |
| IVIG+IVMP | Placebo comparator | 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. Receives: Drug: IVIG+IVMP |
| IVMP | Placebo comparator | 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. Receives: Drug: IVMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale score,EQ-5D-5L,
Evaluate the EDSS score, EQ-5D-5L,
Measured: 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.
Measured: Baseline (before the acute attack treatment), after 1st, 2nd, 3rd, 4th week of hormone treatment, 8th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorder AttackStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410039
- Sponsor's protocol ID
- bejing 301
- Acronym
- ETA/PETA-NMOSD
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eculizumab Add-On Therapy in the Acute Phase of Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Real-World Study
- ClinicalTrials.gov ID
- NCT07410039
- Acronym / sponsor ID
- ETA/PETA-NMOSD / bejing 301
- Keywords
- Neuromyelitis Optica Spectrum Disorder (NMOSD), acute attack phase, eculizumab add-on therapy, AQP4-IgG positive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who met the inclusion and exclusion criteria were divided into three groups for their acute-phase treatment based on their treatment preferences:
- Eculizumab plus treatment group: Eculizumab + IVMP (intravenous methylprednisolone pulse therapy)
- Human immunoglobulin addition treatment group: IVIG + IVMP
- Single IVMP treatment group: IVMP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eculizumab+IVMP | Active comparator | Drug: Eculizumab+IVMPEculizumab 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. |
| IVIG+IVMP | Placebo comparator | Drug: IVIG+IVMPGamma 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. |
| IVMP | Placebo comparator | Drug: IVMPSingle 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 - 65 years old, gender not restricted.
- Patients who meet the diagnostic criteria for NMOSD as set by the International Panel for NMO Diagnosis (IPND) in 2015, and have positive serum AQP4-IgG (by CBA method or live cell method).
- Acute phase of NMOSD-ON, defined as new or worsening optic nerve dysfunction (visual acuity decline accompanied or not by eye pain and visual field defect), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent optic nerve damage on imaging (new or expanded T2WI lesions, with enhancement); the best corrected visual acuity (BCVA) of the affected eye during the acute phase of NMOSD-ON (if both eyes are affected simultaneously, the worse eye is considered) drops from above 0.3 to ≤ 0.1.
- Acute phase of NMOSD-TM, defined as new or worsening spinal cord dysfunction (limb weakness or numbness, accompanied or not by urinary and defecation disorders), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent spinal cord damage on imaging (new or expanded T2WI lesions, with enhancement); the EDSS score during the acute phase of NMOSD-TM increases from ≤ 4.0 to ≥ 6.0.
- Clinical onset and recurrence determination requires unanimous judgment by each center and the center committee (an independent group of 3 people).
Key exclusion criteria (15 listed)
- Damage to the optic nerve or spinal cord caused by other non-NMOSD-related factors.
- Abnormal laboratory indicators that need to be excluded from the subjects include, but are not limited to the following indicators:
- Neutrophils < 1.5 × 109/L, Hemoglobin < 90g/L, Platelet count < 75 × 109/L; Serum creatinine > 1.5 × ULN, Total bilirubin > 1.5 × ULN, Aspartate aminotransferase (AST) > 1.5 × ULN, Alanine aminotransferase (ALT) > 1.5 × ULN, Alkaline phosphatase > 2 × ULN ； HbA1c > 8% (for diabetic patients); GFR < 60 mL/minute/1.73m2.
- Pregnant or lactating women, as well as those planning to become pregnant during the study period.
- Those who have received PE/IA/IVIG/FcRn/B-cell deletion/C5/IL-6 treatment within 1 month before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eculizumab+IVMP(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。 | Drug | Eculizumab+IVMP |
| IVIG+IVMPPatients 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 | Drug | IVIG+IVMP |
| IVMPSingle 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. | Drug | IVMP |
Primary outcome
Expanded Disability Status Scale score,EQ-5D-5L,
Time frame: 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
Evaluate the EDSS score, EQ-5D-5L,
Expanded Disability Status Scale
Time frame: Baseline (before the acute attack treatment), after 1st, 2nd, 3rd, 4th week of hormone treatment, 8th and 12th week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eculizumab+IVMP, IVIG+IVMP and IVMP in people with Neuromyelitis Optica Spectrum Disorder Attack, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dehui huang, Doctoral degree (+86-13911079787, huangdehui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale score,EQ-5D-5L, (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.