Status:
COMPLETED
Treatment for Patients With Osteoarthritis (OA)
Lead Sponsor:
Amgen
Conditions:
Osteoarthritis
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index \[WOMAC\] pain score) of AMG 108 (300 mg subcutaneously \[SC\] eve...
Eligibility Criteria
Inclusion
- Diagnosed with knee OA as determined by American College of Rheumatology (ACR) 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
- 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 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00110942
Start Date
February 1 2005
End Date
November 1 2005
Last Update
June 23 2008
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