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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493116
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : September 16, 2013
Information provided by:

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2003
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Proportion of patients becoming neutralizing antibody negative [ Time Frame: screening and every 3 months from month 3 to month 27 ]
  2. proportion of patients becoming neutralizing antibody positive after treatment with AVONEX [ Time Frame: at baseline and every three months ]
  3. proportion of patents relapse free [ Time Frame: months 6, 12, 18 and 24 ]
  4. total relapses [ Time Frame: 27 months ]
  5. proportion of patients with an increase in EDSS of 1 point [ Time Frame: screening, 3, 9, 15, 21, and 27 months ]
  6. Brain atrophy and cumulative number of enlarging T2 lesions on MRI [ Time Frame: months 0, 12, and 27 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493116

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Coordinating Research Site
NSW, Australia
New Zealand
Research Site
Hamilton, New Zealand
Sponsors and Collaborators
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Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00493116    
Other Study ID Numbers: AUS-8001
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: July 2011
Keywords provided by Biogen:
recovery of efficacy
MxA protein
neutralizing antibodies
Multiple sclerosis
Additional relevant MeSH terms:
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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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Immunologic Factors
Adjuvants, Immunologic