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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00493116
• Date of registration: 25/06/2007
• Prospective Registration: No
• Primary sponsor: Biogen Idec
• Public title: Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta RENeu
• Scientific 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
• Date of first enrolment: October 2003
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00493116
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Australia, New Zealand

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: methylprednisolone

Drug: Interferon-beta-1a

Primary Outcome(s)

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(s)

Brain atrophy and cumulative number of enlarging T2 lesions on MRI [Time Frame: months 0, 12, and 27]

proportion of patents relapse free [Time Frame: months 6, 12, 18 and 24]

proportion of patients becoming neutralizing antibody positive after treatment with AVONEX [Time Frame: at baseline and every three months]

total relapses [Time Frame: 27 months]

Proportion of patients becoming neutralizing antibody negative [Time Frame: screening and every 3 months from month 3 to month 27]

proportion of patients with an increase in EDSS of 1 point [Time Frame: screening, 3, 9, 15, 21, and 27 months]

Secondary ID(s)

AUS-8001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors