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

NCT02440126 | Completed

• 1 other identifier: SRA-001
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; immunological; biomarkers; observational; Relapsing; Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic (PK) Changes over Time

  Changes in natalizumab concentration (ug/ml) will be collected and compared to similar infusion cycle lengths collected previously in investigator-initiated trials at this site.

  12 month

• Pharmacodynamic (PD) Changes over Time

  Changes in natalizumab saturation (%) will be collected and compared to similar infusion cycle lengths collected previously in investigator-initiated trials at this site.

  12 month

Study Arms (4)

Group A: Natalizumab Naïve

This group will consist of up to 10 people who are naïve to natalizumab (haven't received the drug before) and are just beginning therapy. These participants will meet with the study staff at Week 0 (Baseline) prior to their natalizumab infusion. They will then have a follow up appointment every 3 months for the first 12 months of their natalizumab infusions, for a total of 5 visits. Natalizumab concentration and other biomarkers will be measured at each visit.

Group B: Intracycle Regular Dosing

This group will consist of at least 50 people who are on a regular infusing cycle of 28-31 days. These participants will be consented at Week 0 (Baseline) and asked to come back each week during their regular cycle at Week 1, Week 2, and Week 3, for a total of 4 study visits. Natalizumab concentration and other biomarkers will be measured during their participation in the study.

Group C: Intracycle Extended Dosing

This group will consist of up to 60 people who are on an extended infusing cycle of greater than 30 days. These participants will be consented at Week 0 (Baseline) and asked to come back each week for a blood draw to measure Natalizumab concentration and other biomarkers during their extended cycle at Week 2, and Week 4, for a total of 3 study visits.

Group D: Transition Dosing

This group will consist of up to 10 people who are on a regular infusing cycle of 28-30 days who will be transitioning to an extended dosing cycle. The decision to transition will be made by their treating neurologist. These participants will be consented at Week 0 (Baseline) and will be followed for 8 cycles. Natalizumab concentration will be measured at each cycle. During certain cycles, other biomarkers will be measured.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 200 patients with relapsing forms of multiple sclerosis. All subjects will receive open label natalizumab according to their prescribing physician.

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.

Sponsors & Collaborators

• Rocky Mountain MS Research Group, LLC: lead
• Biogen: collaborator

Study Sites (1)

Rocky Mountain MS Research Group

Salt Lake City, Utah, 84103, United States

Location

Related Publications (1)

• Schwab N, Schneider-Hohendorf T, Posevitz V, Breuer J, Gobel K, Windhagen S, Brochet B, Vermersch P, Lebrun-Frenay C, Posevitz-Fejfar A, Capra R, Imberti L, Straeten V, Haas J, Wildemann B, Havla J, Kumpfel 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.

  PMID: 23925765 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John F Foley, MD

  Rocky Mountain MS Research Group, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Sponsor-Investigator

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: May 12, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)