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

Phase 2

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT00371670
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-07
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
- Cartilage volume 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,
- 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
Change from baseline in:
- Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,

Trial Locations

Locations (2)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Novartis; 🇩🇪 Nuernberg, Germany