(1) Diagnosis of GCA
(2) Active disease within 6 weeks of baseline visit
(3) Willing to receive antiplatelet therapy
(4) Willing to receive treatment for prevention of glucocorticoid-induced osteopenia/osteoporosis | (1) Recent or incoming major surgery
(2) Organ transplantation recipient (except corneas within 3 months prior to baseline visit)
(3) Prior treatment with any of the following:
(i) Investigational agents within 12 weeks of screening visit
(ii) Cell depleting agents (i.e., anti-CD20)
(iii) Alkylating agents including CYC
(iv) Tocilizumab
(v) HCQ, CsA, AZA, or MMF within 4 weeks of baseline
(vi) Tumor necrosis factor inhibitors within 2–8 weeks of baseline depending on the agent
(vii) Anakinra within 1 week of baseline
(viii) MTX started within 6 weeks of study enrollment
(ix) CS for other conditions other than GCA
(4) History of severe allergic reactions to monoclonal antibodies
(5) Evidence of serious uncontrolled concomitant disease (i.e., cardiovascular, respiratory, renal, endocrine, etc.)
(6) Current liver disease that could interfere with the trial as determined by the physician investigator
(7) History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation
(8) Infections:
(i) Active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection
(ii) Prior episode of major infection
(iii) Active TB requiring treatment within the previous 3 years
(iv) Untreated latent TB infection (LTBI)
(9) Primary or secondary immunodeficiency
(10) Malignancy (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured)
(11) Laboratory abnormalities: AST or ALT >1.5 × upper limit of normal (ULN), total bilirubin > ULN, platelet count <100 × 109/L, hemoglobin <8.5 gr/dL, WBC count <3 × 109/L, ANC <2 × 109/L, ALC <0.5 × 109/L, positive HBs antigen or positive HCV antibody |
