Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort
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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 |
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 |
Patients with relapsing forms of MS currently being treated with natalizumab.
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Contacts and Locations| United States, Utah | |
| Rocky Mountain Multiple Sclerosis Clinic | |
| Salt Lake City, Utah, United States, 84103 | |
| 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 May 19, 2013