Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort

NCT01070719 | Completed DMC

• 1 other identifier: 001-001-TY
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively infusing natalizumab patient population. A duration effect for progressive multifocal leukoencephalopathy (PML) risk associated with natalizumab therapy appears to exist. There is minimal data available to understand this effect at the biochemical and cellular level. The purpose of this study is to gather preliminary data on several parameters to guide in more focused research on the duration effect.

Conditions

Multiple Sclerosis; Relapse

Keywords

Multiple Sclerosis, relapsing forms

Study Arms (1)

Relapsing form of MS treated with natalizumab

Only patients diagnosed with a relapsing form of Multiple Sclerosis (MS) and who are being treated with Tysabri (natalizumab) will be included in this Phase IV observational study.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing forms of MS currently being treated with natalizumab.

You may qualify if:

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Aged 18 to 75 years old, inclusive, at the time of informed consent.
• Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study.
• Must have been treated with monthly IV infusions of Tysabri® 300 mg for at least 1 month.
• Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with Tysabri®, on file.
• Must weigh between 42 and 126 kg, inclusive.
• Fifteen patients who are 1 month to-12 months of natalizumab therapy, fifteen patients who are 24 months and over of natalizumab therapy will be asked to participate in the TNF alpha subset.

You may not qualify if:

• Medical History:
• History of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
• If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.

Sponsors & Collaborators

• John F. Foley, MD: lead
• Biogen: collaborator

Study Sites (1)

Rocky Mountain Multiple Sclerosis Clinic

Salt Lake City, Utah, 84103, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be collected, and spun for specific tests. The back-up specimens (plasma)will be held in case of a laboratory error.

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: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 1, 2012

Record last verified: 2012-02

Locations

US (1)