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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.
Information provided by:
Biogen Identifier:
First received: June 25, 2007
Last updated: September 12, 2013
Last verified: July 2011
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

Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: Interferon-beta-1a
Drug: methylprednisolone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: October 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00493116

Coordinating Research Site
NSW, Australia
New Zealand
Research Site
Hamilton, New Zealand
Sponsors and Collaborators
  More Information

Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00493116     History of Changes
Other Study ID Numbers: AUS-8001
Study First Received: June 25, 2007
Last Updated: September 12, 2013

Keywords provided by Biogen:
recovery of efficacy
MxA protein
neutralizing antibodies
Multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Autonomic Agents processed this record on April 28, 2017