A multi-centre randomised study to evaluate the efficacy of Betaferon-
A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif)
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
The primary endpoint is time until confirmed NAb−negative status will be assessed, i.e. two consecutive NAb−negative samples taken 3 months apart. This will be compared between the two randomised groups (those taking interferon−beta−1b (Betaferon®) 500mcg subcutaneously every other day)and those remaining on subcutaneous interferon−beta−1a three times a week therapy (Rebif−22 or Rebif−44). The int
Immune response
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
Inclusion: Confirmed diagnosis of MS according to the McDonald criteria (Appendix 1). Exclusion: Treatment with other immunosuppressive, immunomodulatory, or experimental treatments within the last 6 months of enrollment in the study, but excluding pulsed intravenous or oral steroids for treatment of MS relapse.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To assess whether switching MS subjects with NAbs induced by IFNβ-1a (Rebif® 22µg or 44µg) to 500mcg IFNβ-1b (Betaferon®) re-induces tolerance to IFNβ, i.e. causes a higher than expected rate of reversion from NAb-positive to NAb-negative.
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History
Started
Feb 2006