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

NCT04964700 | Unknown

• 1 other identifier: US-TYS-11750
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Natalizumab; Tysabri

Outcome Measures

Primary Outcomes (4)

• Number of reported cases of PML ( progressive multifocal leukoencephalopathy)

  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

  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

  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

  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 Outcomes (4)

• Change in JCV Ab index value

  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.

  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)

  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)

  While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

Interventions

Natalizumab DRUG

Monthly Infusions

Also known as: Tysabri

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Multiple Sclerosis Center of Northeastern New York: lead

Study Sites (1)

Multiple Sclerosis Center of Northeastern New York, P.C.

Latham, New York, 12110, United States

Location

Related Publications (2)

• Gunnarsson M, Malmestrom C, Axelsson M, Sundstrom P, Dahle C, Vrethem M, Olsson T, Piehl F, Norgren N, Rosengren L, Svenningsson A, Lycke J. Axonal damage in relapsing multiple sclerosis is markedly reduced by natalizumab. Ann Neurol. 2011 Jan;69(1):83-9. doi: 10.1002/ana.22247. Epub 2010 Dec 8.

  PMID: 21280078 BACKGROUND

• Miravalle A, Jensen R, Kinkel RP. Immune reconstitution inflammatory syndrome in patients with multiple sclerosis following cessation of natalizumab therapy. Arch Neurol. 2011 Feb;68(2):186-91. doi: 10.1001/archneurol.2010.257. Epub 2010 Oct 11.

  PMID: 20937940 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Keith R Edwards, M.D.

  MS Center of Northeastern New York, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: July 16, 2021
• Study Start: May 6, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)