NCT03446209.

Study name	Tocilizumab for the treatment of familial Mediterranean fever
Methods	Multicenter, parallel, placebo‐controlled, double‐blind phase II RCT Duration: 28 weeks
Participants	People with FMF diagnosed with the Tel‐Hashomer criteria, and fulfill the following criteria Aged 18–64 years of either gender With ≥ 1 heterozygous or homozygous mutation of the MEFV gene Inadequate response or intolerance to colchicine Attack during the last 12 weeks
Interventions	Intervention: tocilizumab intravenously once every 4 weeks for 28 weeks Control: placebo (0.9% physiological saline)
Outcomes	Primary outcome measure: measured change of PGA Secondary outcome measures: adverse events, ESR, SAA, CRP, blood cell count, creatinine, uric acid, GFR, GGT, ALT, AST, bilirubin
Starting date	23 April 2018
Contact information	Jörg Henes, PD Dr Med +49 (0)7071‐29 80681, joerg.henes@med.uni‐tuebingen.de Theodoros Xenitidis, Dr Med +49‐7071‐29 80681, theodoros.xenitidis@med.uni‐tuebingen.de
Notes	ClinicalTrials.gov Identifier: NCT03446209.