The Meteoritics Trial: efficacy of methotrexate after remission-induction with tocilizumab and glucocorticoids in giant cell arteritis—study protocol for a randomized, double-blind, placebo-controlled, parallel-group phase II study

Table 1 Schedule of activities

Visit		1	2	3	4	5	6	7	8	9	10
Timepoint	*Day: -14–0*	Day 0	*Month 1*	*Month 2*	*Month 3*	*Month 4*	*Month 6*	*Month 8*	*Month 12*	*Month 15*	*Month 18*	*At any time during the study*^b
	Screening	Baseline	Treatment Period							Follow-up		Relapse Visit
Written Informed Consent	X
Demography and medical history	X
Inclusion/Exclusion Criteria	X	X
Randomization	X	X^a
Administration of study drug		X	X	X	X	X	X	X	X
*Concomitant Medications*	X	X	X	X	X	X	X	X	X	X	X	X
Safety Assessments
*Physical Examination*	X	X							X	X	X	X
Vital Signs	X	X	X	X	X	X	X	X	X	X	X	X
*12-lead ECG*	X
*Adverse Events*		X	X	X	X	X	X	X	X	X	X	X
*Efficacy Assessments*
*GCA remission assessment, GCA relapse assessment, Patient global assessment, Patient pain assessment, Evaluator Global Assessment of disease activity*	X	X	X	X	X	X	X	X	X	X	X	X
*FACIT- Fatigue, SF-36*		X							X	X	X
*BVAS*		X	X	X	X	X	X	X	X	X	X	X
*Magnetic resonance imaging*		X							X		X
*Laboratory Assessments*
*Serum Chemistry, Hematology, CRP, ESR*	X	X	X	X	X	X	X	X	X	X	X	X
*Pregnancy Test*^c	X^d	X^e	X^e	X^e	X^e	X^e	X^e	X^e	X^e	X^e	X^e	X^e
*Hepatitis B and C testing*	X
*Imaging*
*Ultrasound examination*		X	X	X	X	X	X	X	X	X	X	X
*Magnetic resonance imaging*		X							X		X

ECG Electrocardiography, GCA Giant cell arteritis, CRP C-reactive protein, ESR Erythrocyte sedimentation rate, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy – Fatigue Scale, SF-36 Short Form-36, BVAS Birmingham Vasculitis Activity Score
^aIf not already occurred in the screening phase
^bRelapse visits can be made at any time during the study
^cFor women of childbearing potential
^dserum β-HCG level
^eurine β-HCG level

ISSN: 1745-6215