BridgeMD
New treatment option for Neuromyelitis Optica Spectrum Disorder Attack
Official title Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
ClinicalTrials.gov ID: NCT07410039
What this study is testing
What is Eculizumab+IVMP?
Eculizumab+IVMP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuromyelitis optica spectrum disorder attack.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- Acute phase of NMOSD-TM, defined as new or worsening spinal cord dysfunction (limb weakness or numbness, accompanied or not by urinary and defecation...
- Clinical onset and recurrence determination requires unanimous judgment by each center and the center committee (an independent group of 3 people).
You likely can't join if
- 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 people include, but are not limited to the following indicators: Neutrophils \ 1.5 ×...
- 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...
- Patients with severe internal or external diseases (not limited to such as heart failure, unstable angina pectoris, respiratory failure, pulmonary...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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 people include, but are not limited to the following indicators: Neutrophils \ 1.5 × ULN, Total bilirubin \> 1.5 × ULN, Aspartate aminotransferase (AST)...
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.