Randomized controlled trial in patients on long-term colchicine with colchicine-resistant familial Mediterranean fever (FMF) to evaluate the efficacy of on-demand Anakinra treatment for painful attacks in patients who refuse continuous daily therapy (KIN-ATTACK-FMF).

Familial Mediterranean Fever (FMF)

Mean number of painful days per month at 6 months of treatment.

Efficacy: −Cumulative days of FMF attack treatment from randomization to 6 months, - AIDAI (Auto-inflammatory Diseases activity index) score D0 and M6 Number of painful days and severity of FMF attacks (measured by VAS Visual Analogue Scale) occurring between randomization and M6 − Quality of life score measured by EuroQOL questionnaire (EQ-5D5L) at M6, Safety: − Number of local cutaneous reaction at 6 months (erythema and oedema involving the injection sites) in the anakinra arm − Proportion of adverse events

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