Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort
This study has been completed.
Information provided by (Responsible Party):
John F. Foley, MD, Rocky Mountain Multiple Sclerosis Clinic
First received: February 17, 2010
Last updated: February 28, 2012
Last verified: February 2012
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.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with relapsing forms of MS currently being treated with natalizumab.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070719
|Rocky Mountain Multiple Sclerosis Clinic
|Salt Lake City, Utah, United States, 84103 |
John F. Foley, MD
||John F Foley, MD
||Rocky Mountain MS Research Group, LLC
No publications provided
||John F. Foley, MD, Sponsor-Investigator, Rocky Mountain Multiple Sclerosis Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 17, 2010
||February 28, 2012
||United States: Institutional Review Board
Keywords provided by Rocky Mountain MS Research Group, LLC:
Multiple Sclerosis, relapsing forms
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases