Clinical trial NCT04964700: Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab
Official title: Analysis of Multiple Sclerosis Patients Who Have Had Greater Than 60 Infusions of Natalizumab: Safety and Efficacy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Natalizumab
Tysabri
Lead sponsor: Multiple Sclerosis Center of Northeastern New York
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of reported cases of PML ( progressive multifocal leukoencephalopathy)
timeFrame: While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
measure: Number of documented exacerbations
timeFrame: While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
measure: Change in EDSS Score
timeFrame: One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
measure: Number of new MRI lesions
timeFrame: While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)
Secondary outcomes:
measure: Change in JCV Ab index value
timeFrame: One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
measure: Number of reported clinically significant changes on MRI that may indicate other opportunistic infections.
timeFrame: One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
measure: Number of clinically significant lab values as measured CMP ( Comprehensive Metabolic Panel)
timeFrame: While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
measure: Number of clinically significant lab values as measured by the CBC (Complete Blood Count)
timeFrame: While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)
Other outcomes:
Locations:
city: Latham
country: United States
facility: Multiple Sclerosis Center of Northeastern New York, P.C.
state: New York
Study officials:
affiliation: MS Center of Northeastern New York, P.C.
name: Keith R Edwards, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.