- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04256252
Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)
Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rituximab
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.
|
A scheduled therapeutic regimen with low-dose rituximab was performed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expanded disability status scale (EDSS) score at last follow-up visit
Time Frame: 12 months
|
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.
|
12 months
|
Rituximab-related adverse events
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months
|
Rituximab-related adverse events (AEs) are evaluated and the rate of AEs is recorded.
|
1 month, 3 months, 6 months, 9 months, 12 months
|
Lesions in spinal cords
Time Frame: 6 months, 12 months
|
Changes of lesions in spinal cord were evaluated by MRI scanning.
|
6 months, 12 months
|
Circulating B cell monitoring
Time Frame: 6 months, 12 months
|
Frequencies of total B cell (CD19+) and memory B cell (CD19+CD27+) in lymphocytes were assessed by flow cytometry.
|
6 months, 12 months
|
Switch treatment
Time Frame: 6 months, 12 months
|
Other immunosuppressive agents switched from rituximab and reasons for the switch are recorded.
|
6 months, 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hongzeng Li, Tang-Du Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Myelitis, Transverse
- Optic Neuritis
- Disease
- Neuromyelitis Optica
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- 2014TD-NMOSD
Drug and device information, study documents
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.
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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