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Treatment for Patients With Osteoarthritis (OA) of the Knee

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Intra-articular metHuIL-1ra (anakinra) (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Intra-Articular metHuIL-1ra (Anakinra) in Subjects With Osteoarthritis (OA) of the Knee

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: WOMAC

Secondary outcome: Pain Patient's global assessment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

Starting date: June 2004
Last updated: February 20, 2008

Page last updated: August 23, 2015

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