Rituximab for HTLV-1-associated Myelopathy

Study Overview
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Brief Summary
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Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.

Official Title
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Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy

Conditions
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HTLV-1-associated Myelopathy

Intervention / Treatment
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* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Patients HTLV-1-associated myelopathy (tropical spastic paraparesis) Exclusion Criteria: Anticipated survival of at least 3 years Inability to undergo neuroimaging with Magnetic Resonance Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described) Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome Pregnancy Malignancy (history of or active) Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental: Rituximab group Drug: Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused Placebo Comparator: Control group Patients will receive usual care and drug use.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab group<br>Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused | Drug: Rituximab<br>* A lower dosage of rituximab for HTLV-1-associated myelopathy<br>|
| No Intervention: Control group<br>Patients will receive usual care and drug use. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment | EDSS include the evaluated on visual, brainstem, pyramidal, cerebellar, sensory, bowel-bladder and cerebral functions | up to 360 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immunology function | Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use | up to 360 days |