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

Primary Purpose

Neuromyelitis Optica Spectrum Disorder

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Rituximab

About this trial

This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorder focused on measuring Neuromyelitis Optica Spectrum Disorder, Rituximab

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

All the enrolled patients are followed up and expanded disability status scale (EDSS) score is determined at last follow-up visit. In general, the minimum and maximum scores of EDSS are 0 and 10, respectively, with higher scores meaning a worse outcome.

Rituximab-related adverse events

Rituximab-related adverse events (AEs) are evaluated and the rate of AEs is recorded.

Lesions in spinal cords

Changes of lesions in spinal cord were evaluated by MRI scanning.

Circulating B cell monitoring

Frequencies of total B cell (CD19+) and memory B cell (CD19+CD27+) in lymphocytes were assessed by flow cytometry.

Switch treatment

Other immunosuppressive agents switched from rituximab and reasons for the switch are recorded.

Full Information

NCT ID

NCT04256252

First Posted

February 2, 2020

Last Updated

October 14, 2020

Sponsor

Tang-Du Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04256252

Brief Title

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

Official Title

Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

April 2020 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed Description

Neuromyelitis optica spectrum disorder (NMOSD) is a group of autoimmune inflammatory demyelinating disease of the central nervous system primarily characterized with recurrent optic neuritis and longitudinally extensive transverse myelitis, leading to blindness and paralysis. Incremental disability due to clinical attacks make it essential to prevent relapses with immunosuppressive therapy. Since the serological pathogenic marker anti-aquaporin 4 immunoglobulin G (anti-AQP4 IgG) has been identified, NMOSD has unveiled its autoimmune features with close connections to B cell-mediated humoral immunity. Rituximab, a chimeric monoclonal antibody directly against human CD20 molecular on the surface of B cells, has been reported to deplete peripheral CD20+ B cells and to be highly effective for treating NMOSD, and therefore been recommended as first-line therapy for this disorder. Unfortunately, there are still no consensus statements on dosing and follow-up regimens, which needs investigations to explore the efficacy and safety of different rituximab strategies. Previous studies have provided pilot evidence supporting the use of low-dose rituximab in preventing relapses in Chinese patients with NMO/NMOSD, however, prospective multicenter studies are still needed to determine the effectiveness of the modified strategy in treating NMOSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuromyelitis Optica Spectrum Disorder

Keywords

Neuromyelitis Optica Spectrum Disorder, Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan

Intervention Description

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

Primary Outcome Measure Information:

Title

Annualized relapse rate at last follow-up visit

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Title

Rituximab-related adverse events

Description

Rituximab-related adverse events (AEs) are evaluated and the rate of AEs is recorded.

Time Frame

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

Title

Lesions in spinal cords

Description

Changes of lesions in spinal cord were evaluated by MRI scanning.

Time Frame

6 months, 12 months

Title

Circulating B cell monitoring

Description

Frequencies of total B cell (CD19+) and memory B cell (CD19+CD27+) in lymphocytes were assessed by flow cytometry.

Time Frame

6 months, 12 months

Title

Switch treatment

Description

Other immunosuppressive agents switched from rituximab and reasons for the switch are recorded.

Time Frame

6 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongzeng Li

Organizational Affiliation

Tang-Du Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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