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NCT Number: NCT00371670

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis, Nuremberg, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

balicatib (AAE581)

Drug

Primary outcomes

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

Secondary outcomes

  1. Change from baseline in:

  2. - Cartilage volume in the different regions of the knee after 6 and 12 months,

  3. - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,

  4. - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,

  5. - Joint space width after 6 and 12 months,

  6. - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months

  7. - 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase II, 12-month, Double-blind, Placebo-controlled, Dose-finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-ray

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 4, 2006
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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