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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
John F. Foley, MD, Rocky Mountain Multiple Sclerosis Clinic
ClinicalTrials.gov Identifier:
NCT01070719
First received: February 17, 2010
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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.


Condition
Multiple Sclerosis
Relapse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort

Resource links provided by NLM:


Further study details as provided by Rocky Mountain MS Research Group, LLC:

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.


Enrollment: 270
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. 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.
  2. Aged 18 to 75 years old, inclusive, at the time of informed consent.
  3. 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.
  4. Must have been treated with monthly IV infusions of Tysabri® 300 mg for at least 1 month.
  5. Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with Tysabri®, on file.
  6. Must weigh between 42 and 126 kg, inclusive.
  7. 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.

Exclusion Criteria:

Medical History:

  1. 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.
  2. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070719

Locations
United States, Utah
Rocky Mountain Multiple Sclerosis Clinic
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
John F. Foley, MD
Biogen Idec
Investigators
Principal Investigator: John F Foley, MD Rocky Mountain MS Research Group, LLC
  More Information

No publications provided

Responsible Party: John F. Foley, MD, Sponsor-Investigator, Rocky Mountain Multiple Sclerosis Clinic
ClinicalTrials.gov Identifier: NCT01070719     History of Changes
Other Study ID Numbers: 001-001-TY
Study First Received: February 17, 2010
Last Updated: February 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rocky Mountain MS Research Group, LLC:
Multiple Sclerosis, relapsing forms

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014