Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab

March 23, 2022 updated by: Keith Edwards, M.D., Multiple Sclerosis Center of Northeastern New York

Analysis of Multiple Sclerosis Patients Who Have Had Greater Than 60 Infusions of Natalizumab: Safety and Efficacy

The purpose of this study is to explore the safety and efficacy data in clinic patients who have been treated with Natalizumab for more than 60 continuous infusions.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective chart review and data analysis of patients at the MS Center of Northeastern New York , P.C., who have had greater than 60 continuous infusions prior to the IRB approval date. Only records that are in existence at the time of the IRB review and approval will be accessed for inclusion in the data analysis.

Study Type

Observational

Enrollment (Actual)

42

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

  • United States
    • New York
      • Latham, New York, United States, 12110
        • Multiple Sclerosis Center of Northeastern New York, P.C.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who have received 60 or more infusions in the MS Center of Northeastern New York, P.C. Clinic will be included for analysis.

Description

Inclusion Criteria:

  • Multiple Sclerosis patients treated with long term use of natalizumab--60 or more infusions (5 years)

Exclusion Criteria:

  • Patients who do not have 60 or more infusions (5 years) of Natalizumab.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of reported cases of PML ( progressive multifocal leukoencephalopathy)
Time Frame: While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
Total number of cases of PML as reported by chart review. Progressive multifocal leukoencephalopathy (PML) is a disease of the white matter of the brain, caused by a virus infection that targets cells that make myelin--the material that insulates nerve cells (neurons).
While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
Number of documented exacerbations
Time Frame: While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
Total number of documented exacerbations as reported in chart review . An MS exacerbation or relapse is defined as a monophasic clinical episode with patient-reported symptoms and objective findings typical of MS, reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system, developing acutely or sub-acutely, with a duration of at least 24 hours, with or without recovery, and in the absence of fever or infection.
While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
Change in EDSS Score
Time Frame: One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Expanded Disability Assessment- (EDSS) The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Number of new MRI lesions
Time Frame: While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
Total number of new lesions as reported on MRI (Magnetic Resonance Imaging) MRI can indicate MS disease activity by showing a pattern consistent with inflammation of active demyelinating lesions. It can show types of lesions that are new or getting bigger due to demyelination (damage to the myelin that covers certain nerves).
While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in JCV Ab index value
Time Frame: One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Change in semi-annual JCV Ab (John Cunningham Virus Antibody) index value. The JC Virus (JCV) is associated with a increased risk of progressive multifocal leukoencephalopathy (PML). Detection of antibodies to JCV in serum or plasma is a reliable indicator of exposure to JCV.
One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Number of reported clinically significant changes on MRI that may indicate other opportunistic infections.
Time Frame: One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Number of reported clinically significant changes on MRI as reported. Magnetic Resonance Imaging (MRI) is a non-invasive imaging technology that produces three dimensional detailed anatomical images. It is often used for disease detection, diagnosis, and treatment monitoring.
One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Number of clinically significant lab values as measured CMP ( Comprehensive Metabolic Panel)
Time Frame: While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
A comprehensive metabolic panel (CMP) is a test that measures 14 different substances in your blood. It provides important information about your body's chemical balance and metabolism. Clinically significant changes in values will be recorded.
While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Number of clinically significant lab values as measured by the CBC (Complete Blood Count)
Time Frame: While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
The complete blood count (CBC) is a group of tests that evaluate the cells that circulate in blood, including red blood cells (RBCs), white blood cells (WBCs), and platelets (PLTs). The CBC can evaluate your overall health and detect a variety of diseases and conditions, such as infections, anemia and leukemia. Clinically significant changes in values will be recorded.
While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

Collaborators and Investigators

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

Sponsor

Multiple Sclerosis Center of Northeastern New York

Investigators

  • Principal Investigator: Keith R Edwards, M.D., MS Center of Northeastern New York, P.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 6, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-TYS-11750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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