Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies (RECOVER)
Tracking Information | |||||
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First Received Date ICMJE | June 25, 2007 | ||||
Last Updated Date | January 28, 2008 | ||||
Start Date ICMJE | March 2003 | ||||
Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
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 History | Complete list of historical versions of study NCT00492466 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Relapsing-Remitting Multiple Sclerosis | ||||
Intervention ICMJE |
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Study Arm (s) | Experimental: 1
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 14 | ||||
Completion Date | August 2006 | ||||
Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Finland | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00492466 | ||||
Other Study ID Numbers ICMJE | RECOVER | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | biogen Idec MD, Biogen Idec | ||||
Study Sponsor ICMJE | Biogen Idec | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Biogen Idec | ||||
Verification Date | January 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |