Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
RENeu
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
1 other identifier
interventional
20
2 countries
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2003
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 16, 2013
July 1, 2011
6.2 years
June 25, 2007
September 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA
screening and every 3 months from month 6 to month 27
Secondary Outcomes (6)
Proportion of patients becoming neutralizing antibody negative
screening and every 3 months from month 3 to month 27
proportion of patients becoming neutralizing antibody positive after treatment with AVONEX
at baseline and every three months
proportion of patents relapse free
months 6, 12, 18 and 24
total relapses
27 months
proportion of patients with an increase in EDSS of 1 point
screening, 3, 9, 15, 21, and 27 months
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (2)
Coordinating Research Site
NSW, Australia
Research Site
Hamilton, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
October 1, 2003
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
September 16, 2013
Record last verified: 2011-07