Combination Therapy of Interferon Beta-1b and Tacrolimus: A Pilot Safety Study

Table 1

Schedule of events for each clinic visit.

Visits	1	2	3	4	5	6	7	Extra procedures
	Screening; day -30 to -1	Baseline day 1	Week 6^d	Week 10	Week 14	Week 26	Week 38 final visit	W8, 12, 16, 20, 24, 28, 32
Safety assessment
Physical exam	√	√	√	√	√	√	√
Vital signs	√	√	√	√	√	√	√
Weight	√	√	√	√	√	√	√
Laboratory	√	√ ^a	√				√	√
Serum beta-HCG	√	√ ^a	√	√	√	√	√	√
Tacrolimus levels^b							√	√
Tacrolimus dose adjustment				√ ^c	√ ^c	√ ^c
Adverse events		√	√	√	√	√	√
Efficacy assessment
EDSS		√					√
MSFC		√					√
FAMS		√					√
VAS		√					√
MRI		√					√ ^e

^aIf not done in the last 30 days or if washout period from prohibited medications is required.
^bAt week 8, tacrolimus levels will be obtained predose and 1.5 hours after the dose.
In the event that a change to a chronic medication is needed, tacrolimus blood levels will be obtained within 7–14 days if the concomitant medication is known to interfere with the metabolism of tacrolimus.
^cIf necessary, and at any time during the study period.
^dShould the patient require a longer period to titrate the administration of interferon beta-1b, visit 3 can be delayed until after the patient has been on a full dose of interferon beta-1b for at least 1 month.
^eIn the event of early discontinuation, MRI will be performed at final visit if patient completed at least 3 months of treatment on the combined therapy.