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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab group | Experimental | 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 |
|
| Control group | No Intervention | Patients will receive usual care and drug use. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | A lower dosage of rituximab for HTLV-1-associated myelopathy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology ,First Affiliated Hospital Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39186315 | Derived | Lv A, Fang Y, Lin X, Chen J, Song H, Wang N, Chen WJ, Fu Y, Li R, Lin Y. B-cell depletion limits HTLV-1-infected T-cell expansion and ameliorate HTLV-1-associated myelopathy. Ann Clin Transl Neurol. 2024 Oct;11(10):2756-2768. doi: 10.1002/acn3.52190. Epub 2024 Aug 26. |
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| ID | Term |
|---|---|
| D015493 | Paraparesis, Tropical Spastic |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D015490 | HTLV-I Infections |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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.
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| D006800 |
| Deltaretrovirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |