Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee

Novartis

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Drug: balicatib (AAE581)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371670

CAAE581C2201

Details and patient eligibility

About

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

Enrollment: 223 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind