Efficacy and safety of secukinumab in patients with giant cell arteritis: study protocol for a randomized, parallel group, double-blind, placebo-controlled phase II trial

Table 1 Study schedule (selection)

Period	Screening*		BL	Treatment period															EOT	Safety-FU
Week	−6 to BL	≤ 4 weeks from baseline	0	1	2	3	4	8	12	16	20	24	28	32	36	40	44	48	52	56	60
Inclusion/exclusion criteria	x	x	x
Relevant medical history/concomitant diseases	x
Demography	x
GCA medical history and previous therapies	x
Prior/concomitant medications/non-drug therapy	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Administration of s.c. study treatment			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Prednisolone treatment (26-week taper)			x	x	x	x	x	x	x	x	x	x	x
GCA assessment (signs and symptoms)	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Ultrasound (selected sites)	x												x						x		x
MRA assessment (selected sites)	x												x						x		x
Patient reported outcomes (PGA, EQ-5D, SF-36, FACIT-fatigue)			x				x	x	x	x	x	x	x		x		x		x
PhGA			x				x	x	x	x	x	x	x		x		x		x
GTI			x				x	x	x	x	x	x	x		x		x		x
ESR and CRP			x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x	x
Pharmacokinetic assessments			x				x		x				x								x
Pharmacogenetics			x
Anti-secukinumab antibodies			x				x		x				x		x		x		x		x
Laboratory assessment		x	x				x		x				x		x		x		x

BL, baseline (randomization occurs after the 6-week screening period at baseline); CRP, C-reactive protein; EOT, end of treatment; ESR, erythrocyte sedimentation rate; FU, follow-up; GCA, giant cell arteritis; GTI, glucocorticoid toxicity index; MRA, magnetic resonance angiography; PGA, Patient’s Global Assessment; PhGA, Physician’s Global Assessment
^*Screening Visit 1 and Visit 2 can be performed on the same day if appropriate

ISSN: 1745-6215