The purpose of this study is to evaluate the clinical response in subjects with symptomatic
OA of the knee following a single 50 mg anakinra, 150 mg anakinra or placebo intra-articular
(IA) injection.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria: - Diagnosed with knee OA as determined by American College of
Rheumatology (ACR) criteria - Pain defined by a level of greater than 30 mm on a 100 mm
Visual Analogue Scale (VAS) - No evidence of active effusion or inflammatory flare,
confirmed by investigator - Must exhibit radiographic evidence of tibio-femoral
compartment knee OA within 12 months of screening - Stable doses of any non-prescribed
supplements (e. g. glucosamine or chondroitin sulphate, shark cartilage, diacerhein, soya
extract) for at least 2 months prior to screening - Unchanged use of physical therapy,
biomechanical devices or orthotic support within at least 2 months of screening - Subjects
on nonsteroidal anti-inflammatory drug (NSAID) therapy must discontinue NSAIDs 3 days
prior to baseline (Day 1) - Before any study-specific procedure is performed, the
appropriate written informed consent for participation in the study must be obtained
Exclusion Criteria: - Malignancy within the previous 5 years, except for basal cell or in
situ cancer - Significant hematologic disease - Active infection or history of recurrent
or chronic infections - Known diagnosis of HIV, hepatitis B, or hepatitis C infection -
Uncontrolled diabetes or cardiovascular disease and hypertension - Inflammatory
arthropathy including secondary OA - Isolated OA of the patellofemoral joint (bi or
tri-compartmental involvement are not exclusions) - End-stage ("bone-on-bone") OA
(Kellgren Lawrence score of 4) - OA of the hip ipsilateral to the index knee - Total white
cell count less than 2. 0 x 109/L and/or platelet count less than 100 x 109/L observed
within 1 month preceding screening - Prior IA injection of anakinra or experimental
interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with subcutaneous (SC)
anakinra - Concurrent or recent (less than or equal to 1 month) use of experimental
therapy - Prior IA corticosteroid injection within 1 month of study - Prior
viscosupplement therapy within 3 months of study - Contraindication(s) to IA injections -
Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study -
Subject is not using adequate contraception - Known allergy to E coli-derived products -
Unable to understand informed consent - Concerns regarding subject's compliance with the
protocol procedures - Subject will not be available for follow-up assessment - Active
substance abuse