- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03062579
A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD
Single-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD)
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this study is to determine if the drug tocilizumab as monotherapy contributes to reduce the average relapsing rate (ARR) and improve neurological disability in NMOSD patients, who still have experienced relapses when common immunosuppressive medications including rituximab had been used.
The primary (most important) objectives of this study are to determine: Whether bortezomib reduces relapse frequency in patients with relapsing NMO. The number of attacks during the one year treatment period will be compared to the number of attacks that occurred prior to initiation of tocilizumab treatment.
The secondary objectives are to determine:
The safety profile of tocilizumab in patients with NMO and whether tocilizumab improves walking, visual function and quality of life as measured by a variety of established disability scales.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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Tianjin
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Tianjin, Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of NMOSD, as defined by 2015 criteria.
- NMOSD patients with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
- Provision of written informed consent to participate in the study.
- Peripheral blood B cell count must be normal (5-20% of total lymphocytes) in subjects before administration of tocilizumab.
- EDSS <= 7.5 (8 in special circumstances).
Exclusion Criteria:
- Current evidence or known history of clinically significant infection (HSV, VZV, CMV, EBV, HIV, Hepatitis viruses, Syphilis, etc)
- Pregnant, breastfeeding, or child-bearing potential during the course of the study
- Patients will not participate in any other clinical therapeutic study or will not have participated in any other experimental treatment study within 30 days of screening
- Participation in another interventional trial within the last 3 months
- Heart or kidney insufficiency
- Tumor disease currently or within last 5 years
- Clinically relevant liver, kidney or bone marrow function disorder
- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
- Receipt of IVIG within 1 month prior to randomization.
- Receipt of any other concomitant immunosuppressive therapies including corticosteroids, azathioprine, mycophenolate mofetil.
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: ACTEMRA® (Tocilizumab)
Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, 6 weeks if possible.
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Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, 6 weeks if possible, without concurrent other immunosuppressive treatments.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Number of Neuromyelitis Optica Spectrum Disorder (NMOSD) Attacks Per Year
Time Frame: Baseline, 12 months
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Compare annual relapses rate before and one year after initial tocilizumab administration
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Baseline, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events
Time Frame: Baseline, 12 months
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All adverse events and side effects related to this drug will be recorded.
|
Baseline, 12 months
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Neurological Disability - Expanded Disability Scale Score (EDSS)
Time Frame: Baseline, 12 months
|
The EDSS provides a total score on a scale that ranges from 0 to 10.
The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.
The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death.
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Baseline, 12 months
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Timed 25-foot Walk
Time Frame: Baseline, 12 months
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The Timed 25-Foot Walk test is a quantitative measure of lower extremity function.
If required, the subject may use an appropriate assistive device to walk as quickly as he/she can from one end to the other end of a clearly marked, unobstructed, 25-foot course.
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Baseline, 12 months
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Change in Visual Acuity in eyes involved in NMOSD
Time Frame: Baseline, 12 months
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100% visual acuity and 2.5% contrast visual acuity are examined with high-contrast Sloan letter charts, which are readily available and provide a practical, quantitative, and standardized assessment of visual function.
Each chart consists of rows of black letters (decreasing in size from top to bottom) on a white background.
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Baseline, 12 months
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Retinal Nerve Fiber Layer (RNFL) Thickness Determination
Time Frame: Baseline, 12 months
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Compared RNFL by use of Optical Coherence Tomography (OCT) before and one year after initial tocilizumab administration
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Baseline, 12 months
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Ganglion Cell Complex (GCC) Thickness Determination
Time Frame: Baseline, 12 months
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Compared GCC by use of Optical Coherence Tomography (OCT) before and one year after initial tocilizumab administration
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Baseline, 12 months
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Full Field Visual Evoked Response (VEP) P100 waves
Time Frame: Baseline, 12 months
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To determine the latency and amplitude of full field visual evoked response.
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Baseline, 12 months
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Number of new lesions by T2 hyperintensity in the spinal cord and brain MRI
Time Frame: Baseline, 12 months
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MRIs will be performed for standard of care purposes and will be used to evaluate imaging relapses.
For this trial, the MRIs will be analyzed for counting the number of new lesions by T2 hyperintensity in the spinal cord and brain.
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Baseline, 12 months
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Counts of peripheral blood plasma cells
Time Frame: Baseline, 12 months
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Compare peripheral blood plasma cells before and one year after initial tocilizumab administration
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Baseline, 12 months
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Determination of serum immunoglobulins
Time Frame: Baseline, 12 months
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Compare immunoglobulins before and one year after initial tocilizumab administration
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Baseline, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fu-Dong Shi, MD,PhD, Tianjin Medical University General 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
Other Study ID Numbers
- IRB2017-YX-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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