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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

February 17, 2010
February 28, 2012
February 2010
May 2010   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01070719 on ClinicalTrials.gov Archive Site
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Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort
Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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

  • Multiple Sclerosis
  • Relapse
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070719
001-001-TY
Yes
John F. Foley, MD, Rocky Mountain Multiple Sclerosis Clinic
John F. Foley, MD
Biogen Idec
Principal Investigator: John F Foley, MD Rocky Mountain MS Research Group, LLC
Rocky Mountain MS Research Group, LLC
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP