Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
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|ClinicalTrials.gov Identifier: NCT00336557|
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : October 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Procedure: NAbs testing||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||1230 participants|
|Observational Model:||Case Control|
|Official Title:||A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns Versus Usual Care in High-Dose Interferon Treated Patients|
|Study Start Date :||July 2006|
|Primary Completion Date :||April 2009|
|Study Completion Date :||July 2009|
Regularly Scheduled NAb Testing Arm
Subjects will be scheduled for 5 study visits over the course of 12 months and any NAbs test results will be available to the investigator during the study.
Procedure: NAbs testing
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
Usual Care Arm
Subjects will be scheduled for 2 study visits over the course of 12 months and any NAbs test results will be unknown by the investigator until the conclusion of the subject's study participation.
- Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm [ Time Frame: 1 year ]
- The nature of any therapy/management change in each arm [ Time Frame: 1 year ]
- Reason for change in therapy/management [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336557
Show 49 Study Locations
|Study Chair:||Stephen Glenski, PharmD||Teva Neuroscience, Inc.|