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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04964700
• Other study ID #: US-TYS-11750
• Status: Active, not recruiting
• Start date: May 6, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2022
• Source: Multiple Sclerosis Center of Northeastern New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: June 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Natalizumab
Monthly Infusions

Locations

Country	Name	City	State
United States	Multiple Sclerosis Center of Northeastern New York, P.C.	Latham	New York

Sponsors (1)

Lead Sponsor	Collaborator
Multiple Sclerosis Center of Northeastern New York

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gunnarsson M, Malmeström C, Axelsson M, Sundström 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in JCV Ab index value	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)
Secondary	Number of reported clinically significant changes on MRI that may indicate other opportunistic infections.	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)
Secondary	Number of clinically significant lab values as measured CMP ( Comprehensive Metabolic Panel)	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)
Secondary	Number of clinically significant lab values as measured by the CBC (Complete Blood Count)	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)