Overview

Treatment for Patients With Osteoarthritis (OA) of the Knee

Status:
Completed

Trial end date:
2005-02-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Amgen

Treatments:

Interleukin 1 Receptor Antagonist Protein

Criteria

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