Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Placebo-Controlled Study of the Efficacy and Safety of Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever
Brief Summary: FMF is the most common periodic fever with a worldwide patient population estimated as 150,000, mainly located in the Eastern Mediterranean basin. colchicine is the established therapy of choice ,however, around 20.000 patients worldwide fail to respond or cannot tolerate therapeutic doses, thereby suffering from recurrent debilitating, severe, painful attacks of peritonitis, pleuritis and synovitis and are at risk to die from reactive amyloidosis .Mutation-induced reduction in pyrin/ marenostrin activity is thought to underlie the disease by leading to NALP3 inflammasome activation ,and thereby to IL-1β related burst of inflammation.

The IL-1 receptor antagonist Kineret (Anakinra), seems to be the most appropriate response to the uncontrolled IL-1β elevation. Indeed, an increasing number of reports over the last few years indicate a good response to Kineret (Anakinra), in colchicine-resistant FMF ,also in children ,however, no controlled study has thoroughly evaluated the efficacy and safety of this treatment.

Study outline:

The study aims to run at the FMF centre in Sheba Medical Center, covering more than 10,000 patients. The study will evaluate the effect of recombinant IL-1 receptor antagonist, Kineret (Anakinra), on the frequency of FMF attacks in patients that, despite maximum tolerable dose of colchicine, present with more than one attack per month.

The study is designed as a randomised, placebo-controlled, double-blind study. 50 patients will be randomised to treatment with either Kineret (Anakinra), or placebo treatment for 4 months.


Options:
A: Arm Label: Vehicle; Type: PLACEBO_COMPARATOR; Interventions: Drug: Kineret | Arm Label: Kineret (Anakinra); Type: EXPERIMENTAL; Interventions: Drug: Kineret | Intervention Type: DRUG; Name: Kineret; Assigned to Arm(s): Kineret (Anakinra), Vehicle
B: Arm Label: once daily dosage schema of colchicine; Type: EXPERIMENTAL; Interventions: Drug: colchicine | Arm Label: twice daily dosage schema of colchicine; Type: EXPERIMENTAL; Interventions: Drug: colchicine | Intervention Type: DRUG; Name: colchicine; Assigned to Arm(s): once daily dosage schema of colchicine, twice daily dosage schema of colchicine
C: Arm Label: Placebo (for Rilonacept) and Indomethacin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Indomethacin, Other: Placebo (for Rilonacept) | Arm Label: Rilonacept and Indomethacin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rilonacept, Drug: Indomethacin | Arm Label: Rilonacept and Placebo (for Indomethacin); Type: ACTIVE_COMPARATOR; Interventions: Drug: Rilonacept, Other: Placebo (for Indomethacin) | Intervention Type: DRUG; Name: Rilonacept; Assigned to Arm(s): Rilonacept and Indomethacin, Rilonacept and Placebo (for Indomethacin) | Intervention Type: DRUG; Name: Indomethacin; Assigned to Arm(s): Placebo (for Rilonacept) and Indomethacin, Rilonacept and Indomethacin | Intervention Type: OTHER; Name: Placebo (for Indomethacin); Assigned to Arm(s): Rilonacept and Placebo (for Indomethacin) | Intervention Type: OTHER; Name: Placebo (for Rilonacept); Assigned to Arm(s): Placebo (for Rilonacept) and Indomethacin
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Rilonacept | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Rilonacept; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2

Answer: A