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

NCT ID: NCT04964700

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Natalizumab

Monthly Infusions

Intervention Type DRUG

Other Intervention Names

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Tysabri

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Multiple Sclerosis Center of Northeastern New York

OTHER

Sponsor Role lead

Responsible Party

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Keith Edwards, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith R Edwards, M.D.

Role: PRINCIPAL_INVESTIGATOR

MS Center of Northeastern New York, P.C.

Locations

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

Latham, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21280078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20937940 (View on PubMed)

Other Identifiers

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US-TYS-11750

Identifier Type: -

Identifier Source: org_study_id

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