Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2005-02-28
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Minor sub-study AMG 108
N = 15
Systemic AMG 108
300 mg SC AMG 108 Q4W for 3 doses
Minor sub-study placebo
N = 15
Placebo
SC placebo injection Q4W for 3 doses
Main sub-study AMG 108
N = 73
Systemic AMG 108
300 mg SC AMG 108 Q4W for 3 doses
Main sub-study placebo
N = 73
Placebo
SC placebo injection Q4W for 3 doses
Interventions
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Systemic AMG 108
300 mg SC AMG 108 Q4W for 3 doses
Placebo
SC placebo injection Q4W for 3 doses
Eligibility Criteria
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Inclusion Criteria
* Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
* If currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening
* If utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening
* If currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening
* If currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), must be on stable doses for at least 2 months prior to screening
* Able to discontinue NSAIDs at least 5 half-lives (approximately 3 days) prior to Day 1
* Radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening
* Signed written informed consent
Exclusion Criteria
* 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 10\^9/L and/or platelet count less than 100 x 10\^9/L observed within 1 month preceding screening
* Prior intra-articular (IA) injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with 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
30 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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References
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Cohen SB, Proudman S, Kivitz AJ, Burch FX, Donohue JP, Burstein D, Sun YN, Banfield C, Vincent MS, Ni L, Zack DJ. A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee. Arthritis Res Ther. 2011 Jul 29;13(4):R125. doi: 10.1186/ar3430.
Related Links
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AmgenTrials clinical trials website
To access clinical trial results information click on this link
Other Identifiers
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20040166
Identifier Type: -
Identifier Source: org_study_id