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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 31, 2006
Last updated: March 24, 2017
Last verified: March 2017
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

Condition Intervention Phase
Knee Osteoarthritis Drug: balicatib (AAE581) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in knee cartilage volume in the target compartment after 6 months

Secondary Outcome Measures:
  • 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

Enrollment: 223
Study Start Date: December 2004
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00371670

United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Nuernberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00371670     History of Changes
Other Study ID Numbers: CAAE581C2201
Study First Received: August 31, 2006
Last Updated: March 24, 2017

Keywords provided by Novartis:
Knee, osteoarthritis, pain, disease modifying

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 21, 2017