Longitudinal Analysis And Sample Collection To Evaluate PML Risk Host Markers for PML Risk Host Markers for PML Risk

Completed

Conditions studied: Multiple Sclerosis

In brief

The purpose of the study is to develop an improved understanding of the long term pharmacokinetics and pharmacodynamics of natalizumab with both standard dosing and extended dosing, and collect additional samples to explore cell-based biomarkers of natalizumab treatment and PML risk.

Key facts

Study ID

NCT02440126

Run by

Rocky Mountain MS Research Group, LLC

People needed

196

Starts

2014-10-01

Expected to finish

2020-07-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand the purpose and risks of the study and provide signed and dated consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Must be enrolled in the TOUCH Prescribing Program for Tysabri® (natalizumab) prior to informed consent.
• In the opinion of the Principal Investigator, must be able and willing to comply with all study directions
• ≥ 18 years of age at the time of informed consent

You may not qualify if…

• In the opinion of the Principal Investigator, subject is unwilling or unable to comply with study directions.
• Subject who is pregnant, breastfeeding, or likely to becoming pregnant during the course of the study. Women of child-bearing potential must be practicing an acceptable form of birth control.

Where it is running

• Rocky Mountain MS Research Group — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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