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Completed

NCT Number: NCT00493116

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

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

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Coordinating Research Site, NSW, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon-beta-1a

Drug

dosage and frequency as per Biogen Idec protocol

Other names: Avonex

methylprednisolone

Drug

dosage and frequency as per Biogen Idec protocol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Acronym: RENeu

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2007
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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