Rituximab for HTLV-1-associated Myelopathy
- Sponsor
- First Affiliated Hospital of Fujian Medical University
- Study ID
- NCT04004819
- Phase
- PHASE2
- Status
- Unknown
Conditions
- HTLV-1-associated Myelopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGA lower dosage of rituximab for HTLV-1-associated myelopathy
Study Details
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.
Key Dates
- First listed
- Jul 2, 2019
- Start date
- Aug 15, 2019
- Status verified
- Apr 2022
- Primary completion
- Jul 31, 2023
- Completion
- Jul 31, 2024
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab groupRituximab 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
- No Intervention: Control groupPatients will receive usual care and drug use.
Primary Outcome Measure
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment [ Time Frame: up to 360 days ]