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: September 12, 2013
Last verified: July 2011

June 25, 2007
September 12, 2013
October 2003
December 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00493116 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
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

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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • 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
Experimental: 1
Interventions:
  • Drug: Interferon-beta-1a
  • Drug: methylprednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00493116
AUS-8001
No
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP