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Post marketing surveillance study to evaluate the tolerability of Rebif® New Formulation in patients with relapsing multiple sclerosis in an Australian clinical setting. (ReNew)
Title
Post marketing surveillance study to evaluate the tolerability of Rebif® New Formulation in patients with relapsing multiple sclerosis in an Australian clinical setting. (ReNew)
Type of intervention
Drug
Form of MS
Relapsing-remitting
Brief summary
This observational multicentre study aims to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of injection site reactions (ISRs). The study will allow the comparison of tolerability data with historical data for both Rebif New and classic formulations, and will do so by using the same pre- specified preferred terms of treatment emergent adverse events as done in historical studies. In addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and the impact of Rebif New Formulation on the patient's Quality of Life.
Purpose of study observational, incidence and type of injection site reactions
Inclusion criteria
Anticipated start date
Recruitment status
Recruiting
Recruitment contacts
See contact details in link below
Further details
http://clinicaltrials.gov/ct2/show/NCT01101776?term=multiple+sclerosis+australia&recr=Open&rank=1
Region
VIC, NSW, SA, ACT, WA
Trial results
Last updated: May 2011