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Treatment for Patients With Osteoarthritis (OA) of the Knee
This study has been completed.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00110916
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Intra-articular metHuIL-1ra (anakinra)
Drug: placebo
Phase II

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Anakinra
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • WOMAC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Patient's global assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: June 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Anakinra: Experimental
anakinra
Drug: Intra-articular metHuIL-1ra (anakinra)
anakinra
placebo: Placebo Comparator
placebo
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110916

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20040100
Study First Received: May 16, 2005
Last Updated: February 20, 2008
ClinicalTrials.gov Identifier: NCT00110916  
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Intra-articular
Osteoarthritis
OA
anakinra
Amgen

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Interleukin 1 Receptor Antagonist Protein
Rheumatic Diseases

Additional relevant MeSH terms:
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009