Neuromyelitis Optica Spectrum DisorderPhase 4NCT04256252

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

A Phase 4 study testing Rituximab in people with Neuromyelitis Optica Spectrum Disorder, run by Tang-Du Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Neuromyelitis Optica Spectrum Disorder
What is being tested?: Rituximab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: No sites listed yet
Study dates: Apr 2014to Jun 2020
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Neuromyelitis Optica Spectrum Disorder
Being tested: Rituximab
Keywords: Neuromyelitis Optica Spectrum Disorder, Rituximab
Medical subject headings: Neuromyelitis Optica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RituximabDrug
Also called Rituxan
A scheduled therapeutic regimen with low-dose rituximab was performed.

Study groups in NCT04256252
Study group	Role	What they receive
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. Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (5)

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.
Measured: 12 months
Rituximab-related adverse events
Rituximab-related adverse events (AEs) are evaluated and the rate of AEs is recorded.
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Lesions in spinal cords
Changes of lesions in spinal cord were evaluated by MRI scanning.
Measured: 6 months, 12 months
Circulating B cell monitoring
Frequencies of total B cell (CD19+) and memory B cell (CD19+CD27+) in lymphocytes were assessed by flow cytometry.
Measured: 6 months, 12 months
Switch treatment
Other immunosuppressive agents switched from rituximab and reasons for the switch are recorded.
Measured: 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jun 2020

First posted5 Feb 2020
Study startApr 2014
Primary completionApr 2020
Study completionJun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neuromyelitis Optica Spectrum DisorderStudies of the same condition, open and under way.
More trials run by Tang-Du HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04256252
Sponsor's protocol ID: 2014TD-NMOSD
Status last verified: Oct 2020
First submitted: 2 Feb 2020
Last updated: 19 Oct 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingObservational study
Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis

All Neuromyelitis Optica Spectrum Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial
ClinicalTrials.gov ID: NCT04256252
Acronym / sponsor ID: 2014TD-NMOSD
Conditions: Neuromyelitis Optica Spectrum Disorder
Keywords: Neuromyelitis Optica Spectrum Disorder, Rituximab
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Tang-Du HospitalUniversity, hospital or other
Study start: Apr 2014 (actual)
Primary completion: Apr 2020 (actual)
Study completion: Jun 2020 (actual)
First posted: 5 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rituximab	Experimental	Drug: RituximabIntravenous 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.

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RituximabAlso: RituxanA scheduled therapeutic regimen with low-dose rituximab was performed.	Drug	Rituximab

Primary outcome

Annualized relapse rate at last follow-up visit
Time frame: 12 months
All the enrolled patients are followed up and annualized relapse rate is determined at last follow-up visit.

5 secondary outcomes

Expanded disability status scale (EDSS) score at last follow-up visit
Time frame: 12 months
Rituximab-related adverse events
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Lesions in spinal cords
Time frame: 6 months, 12 months
Circulating B cell monitoring
Time frame: 6 months, 12 months
Switch treatment
Time frame: 6 months, 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.

Related trials for Neuromyelitis Optica Spectrum Disorder

Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingObservational study
Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hongzeng Li study chair

Tang-Du Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rituximab in people with Neuromyelitis Optica Spectrum Disorder, run by Tang-Du Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized relapse rate at last follow-up visit (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04256252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.