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

Information source: Rocky Mountain MS Research Group, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: N/A

Status: Recruiting

Sponsored by: Rocky Mountain MS Research Group, LLC

Official(s) and/or principal investigator(s):
John F Foley, MD, Principal Investigator, Affiliation: Rocky Mountain MS Research Group, LLC

Overall contact:
Tammy Hoyt, MS, ACRP, Phone: 801-408-4584, Email: thoyt@rmmsc.com


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.

Clinical Details

Official title: Longitudinal Meta-Analysis and Further Sample Collection To Evaluate Potential Host Markers for PML Risk

Study design: Observational Model: Cohort

Primary outcome:

Pharmacokinetic (PK) Changes over Time

Pharmacodynamic (PD) Changes over Time

Detailed description: The underlying etiology for the association of natalizumab therapy to an increase risk of progressive multifocal leukoencephalopathy (PML) remains unknown. It is possible that persistently high natalizumab levels lead to sustained immune-modulation or suppression resulting in an increased PML risk. Since 2010 we have conducted three investigator initiated trials (IITs) at our center to measure serum natalizumab concentration, lymphocyte alpha 4 integrin saturation, and other biomarkers to understand the association of these markers to PML risk. A number of the patients who participated in these clinical trials are still infusing. These studies have demonstrated that plasma natalizumab concentrations continue to rise over time with a plateau effect not yet clearly delineated. Improved drug clearance in patients with higher body weight is described in the prescribing information. We have accumulated preliminary data suggesting that patients with lower body weight may be at higher risk for PML and that this may relate to higher drug concentrations and saturations seen in this group. Dose extension may be a viable option to lower drug concentration (pharmacokinetic, PK) and saturation (pharmacodynamic, PD) in patients with lower body weight to potentially impact PML incidence. In addition to the PK/PD of natalizumab, host related biomarkers may allow for more specific PML risk stratification. Further validation of these biomarkers is critical for our understanding of their utility.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. 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. 2. Must be enrolled in the TOUCH Prescribing Program for Tysabri® (natalizumab) prior to informed consent. 3. In the opinion of the Principal Investigator, must be able and willing to comply with all study directions 4. ≥ 18 years of age at the time of informed consent Exclusion Criteria: 1. In the opinion of the Principal Investigator, subject is unwilling or unable to comply with study directions. 2. 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.


Locations and Contacts

Tammy Hoyt, MS, ACRP, Phone: 801-408-4584, Email: thoyt@rmmsc.com

Rocky Mountain MS Research Group, Salt Lake City, Utah 84103, United States; Recruiting
Tammy Hoyt, MS, CCRC, Phone: 801-408-5700, Email: thoyt@rmmsc.com
John F Foley, MD, Principal Investigator
Additional Information

Related publications:

Schwab N, Schneider-Hohendorf T, Posevitz V, Breuer J, Göbel K, Windhagen S, Brochet B, Vermersch P, Lebrun-Frenay C, Posevitz-Fejfár A, Capra R, Imberti L, Straeten V, Haas J, Wildemann B, Havla J, Kümpfel T, Meinl I, Niessen K, Goelz S, Kleinschnitz C, Warnke C, Buck D, Gold R, Kieseier BC, Meuth SG, Foley J, Chan A, Brassat D, Wiendl H. L-selectin is a possible biomarker for individual PML risk in natalizumab-treated MS patients. Neurology. 2013 Sep 3;81(10):865-71. doi: 10.1212/WNL.0b013e3182a351fb. Epub 2013 Aug 7.

Starting date: October 2014
Last updated: May 6, 2015

Page last updated: August 23, 2015

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