Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)
Brief Summary: Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1 beta production and activity. This molecule is very important in the process of inflammation in FMF.

Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes IL-1.

We will enroll in this study 17 subjects from the age of 4 years, including adults with active FMF despite colchicine therapy. Subjects will receive in random order two 3-month courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two 3-month courses of placebo injection. If patients have at least two FMF attacks during a treatment course they will be able to get if they choose the other treatment until the end of that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the cause of FMF.

Funding source - FDA Office of Orphan Products Development


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: 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
C: Arm Label: crFMF: 150 mg; Type: EXPERIMENTAL; Interventions: Drug: Canakinumab | Arm Label: crCMF: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: HIDS/MKD: 150 mg; Type: EXPERIMENTAL; Interventions: Drug: Canakinumab | Arm Label: HIDS/MKD: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: TRAPS: 150 mg; Type: EXPERIMENTAL; Interventions: Drug: Canakinumab | Arm Label: TRAPS: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Canakinumab; Assigned to Arm(s): HIDS/MKD: 150 mg, TRAPS: 150 mg, crFMF: 150 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): HIDS/MKD: placebo, TRAPS: placebo, crCMF: placebo
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: D