Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)

NCT04256252 | Completed Phase 4

• 1 other identifier: 2014TD-NMOSD
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this research, a prospective, multicenter(Tangdu Hospital of Fourth Military Medical University, Xi'an Gaoxin Hospital of Xi'an Medical College, Xianyang Central Hospital, Baoji Central Hospital, Xi'an Central Hospital, The First Hospital of Xi'an, The Fourth Hospital of Xi'an) open-label, follow-up clinical trial will carry out to evaluate the efficacy and safety of low-dose rituximab in treating NMOSD in Northwest China.

Conditions

Neuromyelitis Optica Spectrum Disorder

Keywords

Neuromyelitis Optica Spectrum Disorder; Rituximab

Outcome Measures

Primary Outcomes (1)

• Annualized relapse rate at last follow-up visit

  All the enrolled patients are followed up and annualized relapse rate is determined at last follow-up visit.

  12 months

Secondary Outcomes (5)

• Expanded disability status scale (EDSS) score at last follow-up visit

  12 months

• Rituximab-related adverse events

  1 month, 3 months, 6 months, 9 months, 12 months

• Lesions in spinal cords

  6 months, 12 months

• Circulating B cell monitoring

  6 months, 12 months

• Switch treatment

  6 months, 12 months

Study Arms (1)

Rituximab

EXPERIMENTAL

Intravenous rituximab was administered at a fixed dose of 100 mg once weekly for 3 weeks, followed by maintenance treatment with 100 mg rituximab every 6 months.

Drug: Rituximab

Interventions

Rituximab DRUG

A scheduled therapeutic regimen with low-dose rituximab was performed.

Also known as: Rituxan

Rituximab

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 16 and 75 years old;
• Meet the 2007 or 2015 revised diagnostic criteria for NMOSD;
• At least two relapses in recent two years and/or at least one attack or relapse in recent one years;
• Expanded disability status scale (EDSS) score ≤7.0;
• Willingness to sample collection, imaging study and other disease-related examinations and assessments;
• Results of pregnancy tests for female patients with fertility during the screening period should be negative and effective contraception was used by the patient and her spouse during the study period;
• Patients with informed consent.

You may not qualify if:

• Other immunosuppressive agents are being used or have been discontinued for less than 3 months;
• White blood cell count (WBC) \<3 ×109/L, neutrophil count \<1.5 ×109/L, hemoglobin (HGB) \< 85 g/L, and platelet count (PLT) \< 80×109/L;
• Concomitant active liver disease or persistent elevation of transaminases more than three times above the normal upper limit;
• Serious cardiovascular, kidney, blood and endocrine diseases, or history of malignant tumors, or severe infection;
• Other chronic active immune diseases or stable conditions but requiring immunosuppressants or glucocorticoids, such as rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic or drug-induced immune deficiency;
• Pregnant or lactating patients and those with family planning during the study period;
• Allergy to rituximab and other components;
• Inability to provide informed consent.

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hongzeng Li

  Tang-Du Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: April 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10