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Kineret® (anakinra) Clinical Trial Activity
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Key Clinical Trials
Five randomised, placebo-controlled clinical trials of Kineret® (anakinra) have been completed in a total of 2,932 patients with rheumatoid arthritis (RA): the European Monotherapy Study; the Low-Dose Monotherapy Study; the Methotrexate (MTX) Combination Study; the Confirmatory Efficacy Study; and the Safety Study. The primary end-points of the first four studies were related to clinical efficacy, while primary outcome measures in the fifth study were safety-related. The European Monotherapy Study and the MTX Combination Study have both been published and, along with the Confirmatory Efficacy Study, demonstrate that Kineret® (anakinra) improves the signs and symptoms of RA. A treatment effect was not observed in the Low-Dose Monotherapy Study.
The European Monotherapy Study was a multicentre study that assessed the efficacy and safety of Kineret® (anakinra) at dosages of 30, 75, and 150 mg/day, compared with placebo, in patients (n = 472) with RA not receiving MTX.1
The Low-Dose Monotherapy Study was a relatively small study (n = 141) that investigated lower dosages of Kineret® (anakinra; 2.5, 10, and 30 mg/day), compared with placebo, in patients with RA not receiving MTX.2
The MTX Combination Study was a large-scale study that evaluated the additive effects of escalating dosages of Kineret® (anakinra; 0.04—2.0 mg/kg/day), compared with placebo, in patients (n = 419) who were already receiving MTX for the treatment of RA.3
The Confirmatory Efficacy Study was initiated to gain additional safety and efficacy information on RA patients (n = 501) receiving Kineret® (anakinra) at 100 mg/day in addition to MTX, compared with placebo.4
The Safety Study was conducted to evaluate the safety of Kineret® (anakinra) at 100 mg/day, compared with placebo, in a wide-ranging population of patients (n = 1,399) with RA.5,6
The baseline demographics of patients enrolled in the five Kineret® (anakinra) randomised, placebo-controlled trials were consistent with the general RA population. Patients presented with a wide range of RA disease activity and were receiving a broad range of RA therapies.1-5
Currently Ongoing Studies
Kineret® was shown to relieve pain in a small pilot clinical study in the treatment of osteoarthritis (OA)7. A phase II clinical study with Kineret® in OA will be initiated in Q2 2004.
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