Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta (RENeu)

This study has been completed.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00493116

First received: June 25, 2007

Last updated: June 7, 2012

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 25, 2007
Last Updated Date	June 7, 2012
Start Date ^ICMJE	October 2003
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 11, 2007)	return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA [ Time Frame: screening and every 3 months from month 6 to month 27 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 25, 2007)	return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA [ Time Frame: screening and every 3 months from month 6 to month 27 ]
Change History	Complete list of historical versions of study NCT00493116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 11, 2007)	Proportion of patients becoming neutralizing antibody negative [ Time Frame: screening and every 3 months from month 3 to month 27 ] [ Designated as safety issue: No ] proportion of patients becoming neutralizing antibody positive after treatment with AVONEX [ Time Frame: at baseline and every three months ] [ Designated as safety issue: No ] proportion of patents relapse free [ Time Frame: months 6, 12, 18 and 24 ] [ Designated as safety issue: No ] total relapses [ Time Frame: 27 months ] [ Designated as safety issue: No ] proportion of patients with an increase in EDSS of 1 point [ Time Frame: screening, 3, 9, 15, 21, and 27 months ] [ Designated as safety issue: No ] Brain atrophy and cumulative number of enlarging T2 lesions on MRI [ Time Frame: months 0, 12, and 27 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 25, 2007)	Proportion of patients becoming neutralizing antibody negative [ Time Frame: screening and every 3 months from month 3 to month 27 ] proportion of patients becoming neutralizing antibody positive after treatment with AVONEX [ Time Frame: at baseline and every three months ] proportion of patents relapse free [ Time Frame: months 6, 12, 18 and 24 ] total relapses [ Time Frame: 27 months ] proportion of patients with an increase in EDSS of 1 point [ Time Frame: screening, 3, 9, 15, 21, and 27 months ] Brain atrophy and cumulative number of enlarging T2 lesions on MRI [ Time Frame: months 0, 12, and 27 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
Official Title ^ICMJE	A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability
Brief Summary	This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta
Detailed Description	This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies. Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH. Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Relapsing-Remitting Multiple Sclerosis
Intervention ^ICMJE	Drug: Interferon-beta-1a dosage and frequency as per Biogen Idec protocol Other Name: Avonex Drug: methylprednisolone dosage and frequency as per Biogen Idec protocol
Study Arm (s)	Experimental: 1 Interventions: Drug: Interferon-beta-1a Drug: methylprednisolone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	December 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria EDSS score of 6 or less NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart Reduced bioavailability (relative expression of MxA mRNA/GAPDH Exclusion Criteria: History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs Clinically significant systemic illness History of poorly controlled hypertension, diabetes, or osteoporosis History of uncontrolled seizures within 3 months of enrollment History of Depression or suicidal ideation within 3 months of enrollment Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study abnormal screening blood tests
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	Australia, New Zealand

Administrative Information
NCT Number ^ICMJE	NCT00493116
Other Study ID Numbers ^ICMJE	AUS-8001
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec MD, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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