Kineret anakinra Clinical Trial Activity

1
Kineret (anakinra) Clinical Trial Activity

2
Kineret Has Been Evaluated in Five Randomised,
Placebo-Controlled Trials
n
Daily doses of Kineret
Description
Study
472
European Monotherapy Study
0560
30, 75, 150 mg
2.5, 10, 30 mg
141
Low Dose Monotherapy Study
960182
2.5, 10, 30 mg
419
MTX Combination Therapy Study
960180
0.04, 0.1, 0.4, 1.0, 2.0 mg/kg
501
100 mg
Confirmatory Efficacy Study
990145
1399
100 mg
Safety Study
990757
n number of patients who received at least one
dose of study drug MTX methotrexate
Five Placebo-Controlled Trials
3
Rationale for Initiating a Study Investigating
Kineret at 100 mg/day
Earlier Efficacy Studies
0560 European MonotherapyStudy
960182 Low Dose MonotherapyStudy
960180MTX Combination Therapy Study
Signs and symptoms (1 or 2 mg/kg/day)
Signs and symptoms(150 mg/day)
Lower doses ineffective(?30 mg/day)
990145Confirmatory Efficacy Study
Confirms signs and symptoms efficacy(100 mg/day)
MTX methotrexate