NCT03446209.

Trial name or title	Tocilizumab for the Treatment of Familial Mediterranean Fever
Methods	RCT. Placebo‐controlled and double‐blind phase 2 study. Parallel design. Duration: 28 weeks. Multicenter.
Participants	People with FMF diagnosed with the Tel‐Hashomer criteria, and fulfil the following criteria: • 18 to 64 years of both genders; • with at least one 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 measure: adverse events, ESR, SAA, CRP, blood cell count, creatinine, uric acid, GFR, GGT, ALT, AST, bilirubin.
Starting date	23 April 23 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.

ALT: alanine aminotransferase
 AST: aspartate aminotransferase
 CRP: C‐reactive protein
 ESR: erythrocyte sedimentation rate
 GFR: glomular filtration rate
 GGT: gamma‐glutamyl transferase
 PGA: physician's global assessment
 SAA: serum amyloid A