Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies (RECOVER)
|Relapsing-Remitting Multiple Sclerosis||Drug: Interferon-beta-1a Drug: methylprednisolone||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies|
- Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20) [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
- Change in MxA protein values [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
- Change in binding antibody (Bab) tires [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
- Proportion of patients with NAb positive titre <5 [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
- Change in annualised relapse rate [ Time Frame: at 3, 6, 9, 12, and 15 months ]
- The number of relapse-free patients [ Time Frame: at 3, 6, 9, 12, and 15 months ]
|Study Start Date:||March 2003|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
dosage and frequency as per label
Other Name: AvonexDrug: methylprednisolone
dosage and frequency as per Biogen Idec protocol
This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.
In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.
The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.
Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492466
|Coordinating Research Site|
|Principal Investigator:||Biogen-Idec Investigatorfirstname.lastname@example.org|