Rituximab for HTLV-1-associated Myelopathy

April 12, 2022 updated by: Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Neurology ,First Affiliated Hospital Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Wan-Jian Chen, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rituximab group
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
A lower dosage of rituximab for HTLV-1-associated myelopathy
NO_INTERVENTION: Control group
Patients will receive usual care and drug use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
Time Frame: up to 360 days
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
Time Frame: up to 360 days
Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use
up to 360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2019

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

July 1, 2024

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (ACTUAL)

July 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAHOFFMU[2019]142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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