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Efficacy difference between low dose rituximab and mycophenolate mofetil in preventing recurrence of NMOSD

Efficacy difference between low dose rituximab and mycophenolate mofetil in preventing recurrence of NMOSD

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043013
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-01-31
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis optica spectrum diseases

Interventions

low dose rituximab group: low dose rituximab

Sponsors

Shandong University Qilu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. They met the diagnostic criteria of neuromyelitis optica spectrum disease (nmosd) with AQP4 antibody positive in 2015; 2. They were 18-70 years old; 3. The patient's condition was in the acute stage of relapse, that is, there were new neurological deficit symptoms within 30 days before screening, or the original symptoms worsened, and the symptoms lasted for at least 24 hours without accompanying fever; 4. Disability: EDSS <=7.0; 5. The subjects or their legal representatives voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant women, lactating women and patients with family planning in recent 24 months; 2. Patients receiving rituximab; 3. Human immunoglobulin or other immunosuppressants (such as mycophenolate mofetil, cyclophosphamide, azathioprine, methotrexate, etc.) are being used to affect the efficacy evaluation of drugs, and the withdrawal period is less than 5 half lives; 4. Suffering from uncontrolled acute infection or chronic infection unsuitable for immunosuppressive drugs, such as active hepatitis B or C, tuberculosis, HIV, etc.; 5. Due to severe mental or language disorders, it is impossible to complete the clinical trial or meet the follow-up requirements; 6. Due to serious cardiovascular disease, blood / hematopoietic system disease, respiratory system disease, endocrine disease, kidney / urinary system disease, digestive system disease, congenital or acquired severe immunodeficiency, malignant tumor and other diseases; 7. The researcher thinks that it is not suitable to participate in this clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
vision;visual field;the fundus oculi;Brain magnetic resonance imaging;Magnetic resonance imaging of spinal cord;Magnetic resonance imaging of optic nerve;physical examination;EDSS scale;

Countries

China

Contacts

Public ContactShenjun Wang

Qilu Hospital of Shandong University

junwang9999@sina.com+86 18560085525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026