State Institute for Drug Control

SÚKL identifier allocated to the study:

Type of study:

Study title:

Study ID according to MAH's documents:

Objectives of the study:

Primary objective: To investigate whether there is a relationship between preceding relapse features (i.e. monosymptomatic or polysymptomatic) and a subsequent response to Rebif 44 mcg tiw therapy in MS patients who experienced their therapy escalation.

Further characteristics (study description):

Secondary objectives: To investigate whether there is a relationship between a dominant symptom of the preceding relapse and the subsequent response to Rebif 44 mcg tiw therapy in MS patients who experienced the therapy escalation. To assess relationship between relapse count prior the escalation and the subsequent response to Rebif 44 mcg tiw therapy in MS patients who experienced the therapy escalation. To assess relationship between EDSS status prior the escalation and the subsequent response to Rebif 44 mcg tiw treatment in MS patients who experienced the therapy escalation. To assess relationship between the most disabled functional system (i.e. the Kurtzke's functional system with the highest score on EDSS) prior the escalation and the subsequent response to Rebif 44 mcg tiw treatment in MS patients who experienced the therapy escalation. To assess an overall proportion of patients without clinical disease activity in the study population in the given timepoints. To assess a proportion of patients without clinical disease activity, separately in each group specified by their previous DMD therapy, in the study population in the given timepoints.

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End of data collection:

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Expected date of final report submission:

Date of protocol approval:

End of data collection date: