An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects

Table 1 Treatment period and evaluation schedule

	Screening visit		Injection using the prefilled syringe				Injections using the prefilled pen			EOS or EW
	Clinic	Clinic	Clinic	Clinic	Clinic	Clinic	Clinic	Home	Clinic	Clinic
	14-day period	Day 1	Day 2	Day 3	Day 8	Day 9	Day 10	Day 15	Day 22	Day 23
Treatment and evaluations		Injection 1			Injection 2			Injection 3	Injection 4
Study enrollment		x
Injection using the prefilled syringe		x
Neopterin serum sample collection		x^a	x^b	x^c	x^a	x^b	x^c
Prefilled pen training					x
Injection using the prefilled pen					x			x	x
Patient assessment of the prefilled pen training materials					x			x	x
Patient assessment of injection site pain		x^d			x^d			x^d	x^d
Patient assessment of ease of use		x			x			x	x
Patient assessment of injection procedure		x			x			x	x
Clinician assessment of injection site		x^e	x		x^e	x			x^e	x
Observation form									x
Preference questionnaire										x
Patient assessment and dosing information forms dispensed					x
Concomitant therapy and adverse events	Monitor and record throughout study

EOS, end of study; EW, early withdrawal.
^aNeopterin samples were to be obtained 1 hour pre-injection.
^bNeopterin serum samples were to be obtained 24 hours ± 2 hours post-injection.
^cNeopterin serum samples were to be obtained 48 hours ± 2 hours post-injection.
^dTo be completed within 1 hour before injection and also immediately after injection.
^eClinician injection site assessment was to be performed within 1 hour before injection.

ISSN: 1471-2377