Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT00336557
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-06-12
• Study First Submitted QC: 2006-06-12
• Study First Posted: 2006-06-13
• Study Start: 2006-07
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1230

Inclusion Criteria

• Willing to provide informed consent.
• Male or female, 18 years of age or older, with a diagnosis of MS.

Exclusion Criteria

• Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit.
• Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months.
• Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study.
• Previously participated in this study.
• Has received an experimental drug in the last thirty (30) days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm	1 year

Secondary Outcome Measures

Name	Time	Method
The nature of any therapy/management change in each arm	1 year
Reason for change in therapy/management	1 year

Trial Locations

Locations (49)

Phoenix Neurological Associates, LTD; 🇺🇸 Phoenix, Arizona, United States

East Bay Physicians Medical Group; 🇺🇸 Berkley, California, United States

Neuro-Pain Medical Center; 🇺🇸 Fresno, California, United States

Fullerton Neurology and Headache Center; 🇺🇸 Fullerton, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

Neurology Clinic of Marin; 🇺🇸 San Anselmo, California, United States

Colorado Springs Neurological Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

Colorado Neurosurgery; 🇺🇸 Engelwood, Colorado, United States

The Emery Neuroscience Center; 🇺🇸 Ft. Lauderdale, Florida, United States

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