Design of the Tocilizumab in Giant Cell Arteritis Trial

Table 1

Critical trial definitions.

Term	Definition
Revised GCA diagnosis criteria	(1) Age ≥50 years; (2) History of ESR ≥50 mm/hour; (3) And at least one of the following: (a) Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); (b) Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness; (4) And at least one of the following: (a) Temporal artery biopsy revealing features of GCA; (b) Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)
New onset GCA	Diagnosis of GCA made within 6 weeks of baseline visit
Relapsing/refractory GCA	Diagnosis of GCA >6 weeks of baseline visit and active disease within 6 weeks of baseline visit
Active GCA	(1) At least one of the following within 6 weeks of baseline visit; (a) Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); (b) Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness; (c) Other features judged by the clinician investigator to be consistent with GCA or PMR flares (i.e., new or worsened extremity claudication, fever of unknown origin); (2) And ESR ≥30 mm/hr or CRP ≥1 mg/dL
Remission	Absence of all symptoms attributable to active GCA and normalization of ESR (<30 mm/hr) and CRP (<1 mg/dL)
Flare	Recurrence of symptoms attributable to active GCA, with or without elevation of ESR and/or CRP
Sustained remission (SR)	(1) Absence of flare following remission by week 12 after randomization; (2) And completion of the assigned prednisone taper; (3) And not having required escape therapy at any time by week 52.