Knee Osteoarthritis
Conditions
Keywords
Knee, osteoarthritis, pain, disease modifying
Brief summary
This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray
Interventions
DRUGbalicatib (AAE581)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Inclusion criteria
* At least one knee with osteoarthritis with Kellgren-Lawrence grade 3 * Significant osteoarthritis pain in the knee * Presence of at least one of the risk factors: obesity (BMI \> 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement
Exclusion criteria
* Women with childbearing potential * Secondary osteoarthritis * Treatment with intra-articular or systemic steroids * Inability to undergo MRI acquisition Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in knee cartilage volume in the target compartment after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cartilage volume in the different regions of the knee after 6 and 12 months, | — |
| - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months, | — |
| - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months, | — |
| Change from baseline in: | — |
| - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months | — |
| - Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months | — |
| - Joint space width after 6 and 12 months, | — |
Countries
Germany, United States
Outcome results
None listed