Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder (PANDA)

April 27, 2025 updated by: Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University

Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial

To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 518000
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei Qiu, MD;phD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The inclusion criteria for the study are as follows:

    1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
    2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
    3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
    4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
  3. Participants with contraindications to intravenous methylprednisolone treatment.
  4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
  5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
  6. Severe Bleeding or Bleeding Disorders
  7. Severe Heart Failure
  8. Severe Infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume. Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).
Device: Protein A immunoadsorption
The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume.
Active Comparator: control group
The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).
Drug: intravenous methylprednisolone
The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of the treatment, the change in the Kurtzke Expanded Disability Status Scale (EDSS) score is evaluated one month after the start of treatment compared to the baseline. The baseline is defined as the patient's condition before
Time Frame: Evaluation timing includes from the screening period to the baseline and the EDSS score assessment one month after starting treatment.

To assess the effectiveness of the treatment, the change in the Kurtzke Expanded Disability Status Scale (EDSS) score is evaluated one month after the start of treatment compared to the baseline. The baseline is defined as the patient's condition before treatment began, or if the patient had not yet reached a plateau during the initial treatment phase and continued to worsen during hospitalization, the most severe stage during the current hospitalization is used as the baseline.The EDSS is a scale used for the objective and repeatable quantification of disability in patients, with scores ranging from 0 to 10. A score of 0 indicates normal function, while a score of 10 indicates death. An increase in the EDSS score reflects worsening symptoms.The method of evaluation involves calculating the EDSS score difference as follows:

EDSS Score Difference = EDSS Score (Baseline) - EDSS Score (1 Month After Treatment Start).
Evaluation timing includes from the screening period to the baseline and the EDSS score assessment one month after starting treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Beijing Friendship Hospital
Second Xiangya Hospital of Central South University
Second Affiliated Hospital of Guangzhou Medical University
Guangdong 999 Brain Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-330-02
  • WQiu (Registry Identifier: WQiu)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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