HTLV-1-associated Myelopathy
Conditions
Brief summary
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.
Interventions
DRUGRituximab
A lower dosage of rituximab for HTLV-1-associated myelopathy
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment | up to 360 days | EDSS include the evaluated on visual, brainstem, pyramidal, cerebellar, sensory, bowel-bladder and cerebral functions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in immunology function | up to 360 days | Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use |
Countries
China
Outcome results
None listed