Rituximab for HTLV-1-associated Myelopathy

Phase 2

• Conditions: HTLV-1-associated Myelopathy
• Interventions: Drug: Rituximab

• Registration Number: NCT04004819
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Study Start: 2019-08-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19
• Primary Completion: 2023-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab group	Rituximab	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neurology ,First Affiliated Hospital Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China