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| Sponsored by: |
Teva Pharmaceutical Industries |
| Information provided by: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00336557 |
Purpose
An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy
| Condition | Intervention | Phase |
|
Multiple Sclerosis |
Procedure: NAbs testing |
Phase IV |
| MedlinePlus related topics: | Multiple Sclerosis |
| ChemIDplus related topics: | Interferon alfa-2b Interferons |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| 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 |
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
| Estimated Enrollment: | 2440 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2008 |
Randomized, controlled, open-label parallel group study. All high-dose IFN patients willing to consent will be given a Binding Antibody (BAb) test and if it is positive (>4 units), a Neutralizing Antibody (NAb) test will also be done. Patients will be randomized to one of two arms:
Regularly Scheduled Nab Testing Arm: Patients will be followed-up for 12 months. At least 2 NAb and BAb tests will be performed during the study.
Usual Care Arm: Patients will be followed-up for 12 months under usual care conditions.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Teva Neuroscience | 1-800-221-4026 |
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Show 61 Study Locations |
| Teva Pharmaceutical Industries |
| Study Chair: | Stephen Glenski, PharmD | Teva Neuroscience, Inc. |
More Information
| Responsible Party: | Teva Neuroscience ( J. Michael Nicholas, Ph.D., Sr. Director, US Regulatory Affairs ) |
| Study ID Numbers: | PM028 |
| First Received: | June 12, 2006 |
| Last Updated: | November 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00336557 |
| Health Authority: | United States: Food and Drug Administration |
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