Osteoarthritis
Conditions
Keywords
Intra-articular, Osteoarthritis, OA, anakinra, Amgen
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 \[SC\] every 4 weeks) in subjects with OA.
Interventions
DRUGSystemic AMG 108
300 mg SC AMG 108 Q4W for 3 doses
OTHERPlacebo
SC placebo injection Q4W for 3 doses
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC pain score | Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in WOMAC pain score | Week 12 |
| Change in WOMAC composite score and function and stiffness index scores | Weeks 6 and 12 |
| Achieving 50% or more improvement from Day 1 in the WOMAC | Weeks 6 and 12 |
Outcome results
None listed