Primary Outcomes

Description: Difference in number of attacks per treatment month between rilonacept and placebo

Measure: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks.

Time: attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)

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Description: Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections.

Measure: To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo.

Time: 12 months of entire study length

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Secondary Outcomes

Description: This outcome was the difference in days in the length of attacks between rilonacept and placebo.

Measure: To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo.

Time: 12 months

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Description: The percentage of rilonacept and placebo treatment courses without FMF attacks.

Measure: Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses.

Time: Each treatment course of up to 3 months

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Description: Differences between rilonacept and placebo in the percentage of courses that attained at least a 50% decrease in FMF attacks when compared to attacks in the screening period.

Measure: To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses.

Time: Up to 3 months for each treatment course

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Description: In a survival analysis we measured the difference (in days) until the development of the first and second attack within a treatment course of up to 3 months and examined differences in this parameter between rilonacept and placebo. Data regarding the development of the second attack are reported below. In regards to the first attack there were no significant differences between rilonacept and placebo (20 days (7.5,>90)for rilonacept; 15 (8,32) for placebo, P=0.066).

Measure: To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo).

Time: 3 months

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Description: Erythrocyte sedimentation rate - ESR (mm/h)

Measure: To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo).

Time: 3 months (each treatment course, overall 12 months)

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Description: Differences between the treatment courses in the C-Reactive Protein levels mg/L

Measure: To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo)

Time: 3 months (each treatment course, overall 12 months)

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Description: The difference between the treatment arms in the platelet count X 10 to the power of 9

Measure: To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo)

Time: 3 months (each treatment course, overall 12 months)

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Description: The differences between treatment arms in the fibrinogen level (micromol/L)

Measure: To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo)

Time: 3 months (each treatment course, overall 12 months)

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Description: The difference between the treatment arms in serum amyloid A levels (mg/L)

Measure: To Determine the Differences in Serum Amyloid A Levels Between the Treatment Arms (Rilonacept vs. Placebo)

Time: 3 months (each treatment course, overall 12 months)

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Description: Differences in the health-related quality of life (HRQOL) during treatment with rilonacept vs. placebo. HRQOl was measured by the Childhood Health Questionnaire which was adopted also for adults. There are 2 summary scores: 1. Physical summary score. 2. Psychosocial summary score. The data reported below in the upper table is the physical summary composite score and in the lower table the psychosocial summary composite score. Scores were from 0-100 (higher is better) with a score of 50 representing the mean of the normal population.

Measure: To Determine the Differences in the Quality of Life Between the Treatment Arms (Rilonacept vs. Placebo).

Time: 12 months

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Description: Differences in the Armenian Evaluation Score between rilonacept and placebo courses. The Armenian Evaluation Score is a composite score of disease severity based on the frequency, duration and character of attacks (degree of fever and severity of serositis). It was adapted to calculate a score for a 3-month treatment course. The lowest (best) score is 0 and higher values are worse. In theory there is no upper limit to the scale. The total score is reported (there are no subscales).

Measure: To Determine the Differences in the FMF Severity Score of the Subjects Between the Treatment Arms (Rilonacept vs. Placebo).

Time: overall 12 months

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Description: The proportion of time within the trial that participants received rilonacept as opposed to placebo. The reason for this outcome is that participants who had at least 2 attacks within an individual treatment course were able to "escape" in a blinded manner to the other treatment arm until the end of that treatment course and then resume the original randomization sequence. Thus participants may have been treated for a longer time with one treatment arm or the other.

Measure: To Determine the Differences in the Proportion of Time Subjects Received Rilonacept vs Placebo

Time: 12 months

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