Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical
Completed
Conditions studied: Multiple Sclerosis
In brief
This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed to assess the longitudinal pharmacokinetic, pharmacodynamic, immunological, and biochemical sample collection with MRI and relapse analysis of a Tysabri patient cohort. The study hopes to identify secondary and tertiary risk stratification markers that would aid in the clinical management of patients who are JC antibody positive.
Key facts
- Study ID
- NCT01330498
- Run by
- John F. Foley, MD
- People needed
- 229
- Starts
- 2011-04-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2012-01-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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 80 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 participated in IIT I (Foley, IIT 1 001-001-TY) in March, April, or May of 2010.
- Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with natalizumab, on file.
- Must weigh between 38 and 180 kg, inclusive.
- Up to 40 patients will be asked to also participate in Part B, the PK/PD subset,
- Approximately fifty patients will be asked to also participate in the sub-study Part C. These patients will have been in the bottom 20th percentile for iATP in Foley IIT 1 001-001-TY.
You may not qualify if…
- 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.
- If subject consumes alcohol within 24 hours of blood specimen collection.
Where it is running
- Rocky Mountain Multiple Sclerosis Clinic — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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