A randomized, multicenter, two-arm, open-label, phase IIIb study to ev
A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis.
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
The primary endpoint is the FLS score from the MSTCQ at week 4. This is defined as the sum of the scores for “side effects” section questions 1-4, corresponding to a maximum total score of 20.
Safety
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: Subject with Relapsing Forms of MS (RMS) Exclusion: Secondary Progressive Multiple Sclerosis (SPMS) without superimposed attacks
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 subject satisfaction by the MS Treatment Concern Questionnaire (MSTCQ) specifically measuring Flu Like Symptoms (FLS) during the first 4 weeks after subjects transitioned to RNF in 2 treatment groups: one treatment group receives ibuprofen prophylactically and the other ibuprofen PRN.
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History
Started
Apr 2007