Is IFN-beta Treatment in MS Useful After a Washout Period in Patients
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
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
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
Immune responseHow the body handles the medicine
Other measures (6)
Proportion of patients becoming neutralizing antibody negative
screening and every 3 months from month 3 to month 27
Immune responseproportion of patients becoming neutralizing antibody positive after treatment with AVONEX
at baseline and every three months
Immune responseproportion of patents relapse free
months 6, 12, 18 and 24
Relapsestotal relapses
27 months
Relapsesproportion of patients with an increase in EDSS of 1 point
screening, 3, 9, 15, 21, and 27 months
Disability progressionBrain atrophy and cumulative number of enlarging T2 lesions on MRI
months 0, 12, and 27
MRI lesionsBrain volume loss
Who could take part
Relapsing MS · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Oct 2003
Main results due
Dec 2009
Finished
Dec 2009