A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis.
Hoffman GS., Cid MC., Hellmann DB., Guillevin L., Stone JH., Schousboe J., Cohen P., Calabrese LH., Dickler H., Merkel PA., Fortin P., Flynn JA., Locker GA., Easley KA., Schned E., Hunder GG., Sneller MC., Tuggle C., Swanson H., Hernández-Rodríguez J., Lopez-Soto A., Bork D., Hoffman DB., Kalunian K., Klashman D., Wilke WS., Scheetz RJ., Mandell BF., Fessler BJ., Kosmorsky G., Prayson R., Luqmani RA., Nuki G., McRorie E., Sherrer Y., Baca S., Walsh B., Ferland D., Soubrier M., Choi HK., Gross W., Segal AM., Ludivico C., Puechal X., International Network for the Study of Systemic Vasculitides .
OBJECTIVE: To evaluate treatment with methotrexate (MTX) in patients with newly diagnosed giant cell arteritis (GCA) to determine if MTX reduces GCA relapses and cumulative corticosteroid (CS) requirements and diminishes disease- and treatment-related morbidity. METHODS: This was a multicenter, randomized, double-blind study. Over 4 years, 16 centers from the International Network for the Study of Systemic Vasculitides enrolled patients with unequivocal GCA. The initial treatment was 1 mg/kg/day (