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

Novartis Pharmaceuticals223 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

223

Conditions

Knee Osteoarthritis

Interventions

balicatib (AAE581)DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pinnacle Research Group

Anniston, Alabama, United States

Novartis

Nuremberg, Germany

Outcomes

Primary Outcomes

Change from baseline in knee cartilage volume in the target compartment after 6 months

Secondary Outcomes

Change from baseline in:

- 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,

- Joint space width after 6 and 12 months,

- 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

Data from ClinicalTrials.gov

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